Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (NCT NCT04044690)
NCT ID: NCT04044690
Last Updated: 2025-12-09
Results Overview
A responder was defined as a participant with a TIS \>= 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS was a sum response criterion which incorporates 6 weighted international myositis assessment and clinical studies (IMACS) core set measures (CSMs) including Physician and Patient Global Disease Activity (PGA), Manual Muscle Testing-8 (MMT-8), Health Assessment Questionnaire, Muscle Enzyme, and Extramuscular Global Activity (EGA). Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Percentage of responders at Week 25 based on TIS are reported here. Multiple imputation (MI) was used to impute missing values for participants who discontinued due to the military activities in Ukraine.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
134 participants
Primary outcome timeframe
At Week 25
Results posted on
2025-12-09
Participant Flow
This study was conducted from 21 October 2019 to 02 December 2024.
A total of 199 participants were screened, and 65 of these were screen failures. A total of 134 were randomized in the study. This study consisted of 3 study periods (SP): SP1 (from Baseline to Week 25), SP2 (from Week 25 to 56) and SP3 (from Week 56 to approximately 5 years, study drug reimbursement was planned until drug becomes commercially available or if there is no longer benefit from the study drug). However, the study was terminated early.
Participant milestones
| Measure |
Sequence A: IgPro20 / IgPro20 / IgPro20
Participants received IgPro20 subcutaneous (SC) infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (Total Improvement Score \[TIS\] greater than or equal to (\>=) 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the end of the study (EOS) (up to 5 years).
|
Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|
|
Period 1
STARTED
|
67
|
67
|
|
Period 1
Treated
|
67
|
67
|
|
Period 1
COMPLETED
|
56
|
55
|
|
Period 1
NOT COMPLETED
|
11
|
12
|
|
Period 2
STARTED
|
56
|
55
|
|
Period 2
Treated
|
56
|
55
|
|
Period 2
COMPLETED
|
40
|
38
|
|
Period 2
NOT COMPLETED
|
16
|
17
|
|
Period 3
STARTED
|
36
|
34
|
|
Period 3
Treated
|
36
|
34
|
|
Period 3
COMPLETED
|
11
|
12
|
|
Period 3
NOT COMPLETED
|
25
|
22
|
Reasons for withdrawal
| Measure |
Sequence A: IgPro20 / IgPro20 / IgPro20
Participants received IgPro20 subcutaneous (SC) infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (Total Improvement Score \[TIS\] greater than or equal to (\>=) 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the end of the study (EOS) (up to 5 years).
|
Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|
|
Period 1
Lack of Efficacy
|
1
|
1
|
|
Period 1
Adverse Event
|
4
|
2
|
|
Period 1
Physician Decision
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
2
|
5
|
|
Period 1
Protocol Deviation
|
2
|
0
|
|
Period 1
Site Terminated by Sponsor
|
0
|
1
|
|
Period 1
Study Terminated by Sponsor
|
0
|
1
|
|
Period 1
Death
|
1
|
1
|
|
Period 1
Other: Unspecified
|
1
|
0
|
|
Period 2
Lack of Efficacy
|
0
|
1
|
|
Period 2
Adverse Event
|
0
|
1
|
|
Period 2
Physician Decision
|
0
|
2
|
|
Period 2
Withdrawal by Subject
|
5
|
5
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
|
Period 2
Site Terminated by Sponsor
|
1
|
3
|
|
Period 2
Study Terminated by Sponsor
|
8
|
3
|
|
Period 2
Death
|
1
|
0
|
|
Period 2
Other: Unspecified
|
1
|
1
|
|
Period 3
Site Terminated by Sponsor
|
1
|
2
|
|
Period 3
Study Terminated by Sponsor
|
24
|
18
|
|
Period 3
Missing
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Baseline characteristics by cohort
| Measure |
IgPro20
n=67 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1.
|
Placebo
n=67 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 15.86 • n=9 Participants
|
49.1 years
STANDARD_DEVIATION 14.02 • n=6 Participants
|
50.3 years
STANDARD_DEVIATION 14.96 • n=9 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=9 Participants
|
51 Participants
n=6 Participants
|
98 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
36 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=9 Participants
|
15 Participants
n=6 Participants
|
29 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=9 Participants
|
49 Participants
n=6 Participants
|
100 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
10 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
48 Participants
n=9 Participants
|
50 Participants
n=6 Participants
|
98 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: At Week 25Population: Analysis was performed on the modified intent-to-treat (mITT) analysis set. The mITT analysis set comprises all participants who underwent study screening procedures, were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP or the lack of any post randomization efficacy data lead to the exclusion of the participant from the mITT.
A responder was defined as a participant with a TIS \>= 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS was a sum response criterion which incorporates 6 weighted international myositis assessment and clinical studies (IMACS) core set measures (CSMs) including Physician and Patient Global Disease Activity (PGA), Manual Muscle Testing-8 (MMT-8), Health Assessment Questionnaire, Muscle Enzyme, and Extramuscular Global Activity (EGA). Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Percentage of responders at Week 25 based on TIS are reported here. Multiple imputation (MI) was used to impute missing values for participants who discontinued due to the military activities in Ukraine.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Responder Rate
|
64.3 percentage of participants
Interval 52.56 to 75.99
|
61.6 percentage of participants
Interval 49.52 to 73.74
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100; higher the score, better the condition), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Least squares (LS) means were estimated using a mixed model repeated measures (MMRM) including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (\<=142 points vs \>142 points) as fixed effects, participant as a random effect.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Mean TIS
|
32.24 score on a scale
Interval 25.275 to 39.208
|
30.78 score on a scale
Interval 23.668 to 37.896
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The MMT-8 was a set of 8 designated muscles which were tested bilaterally (potential score ranging from 0 to 150): 7 biaxial muscles with a potential score 0 to 140 and 1 axial (neck flexors) with a potential score of 0 to 10. Improvement is documented with an increase in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, and region as fixed effects, baseline MMT-8 as a continuous covariate and participant as a random effect.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Mean Changes From Baseline in MMT-8
|
8.9 score on a scale
Interval 4.08 to 13.78
|
11.3 score on a scale
Interval 4.79 to 17.89
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The CDASI in its modified version 2 (V2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (\<=142 points vs \>142 points) as fixed effects, baseline CDASI-A as a continuous covariate, and participants as a random effect.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Mean Changes From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Total Activity Score (CDASI-A)
|
-10.6 score on a scale
Interval -13.28 to -7.82
|
-5.3 score on a scale
Interval -8.29 to -2.28
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
Reduction in corticosteroid dose.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%
|
23.2 percentage of participants
Interval 12.89 to 33.45
|
20.2 percentage of participants
Interval 10.39 to 30.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 5, 9, 13, 17, 21, and 25Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points on the TIS.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=59 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=62 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 1: Mean TIS at Each Visit
Week 5
|
23.22 score on a scale
Standard Deviation 16.387
|
20.97 score on a scale
Standard Deviation 16.684
|
—
|
—
|
—
|
—
|
|
Period 1: Mean TIS at Each Visit
Week 9
|
32.54 score on a scale
Standard Deviation 18.132
|
26.67 score on a scale
Standard Deviation 17.924
|
—
|
—
|
—
|
—
|
|
Period 1: Mean TIS at Each Visit
Week 13
|
37.68 score on a scale
Standard Deviation 17.267
|
31.68 score on a scale
Standard Deviation 20.705
|
—
|
—
|
—
|
—
|
|
Period 1: Mean TIS at Each Visit
Week 17
|
41.00 score on a scale
Standard Deviation 16.926
|
35.44 score on a scale
Standard Deviation 21.458
|
—
|
—
|
—
|
—
|
|
Period 1: Mean TIS at Each Visit
Week 21
|
43.56 score on a scale
Standard Deviation 17.112
|
36.67 score on a scale
Standard Deviation 21.882
|
—
|
—
|
—
|
—
|
|
Period 1: Mean TIS at Each Visit
Week 25
|
40.20 score on a scale
Standard Deviation 20.093
|
40.21 score on a scale
Standard Deviation 21.812
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 25, 29, 33, 37, 41, 45, 49, and 53Population: Analysis was performed on the mITT analysis set extended (mITT-Ex) that comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points on the TIS.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=54 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=52 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 2: Mean TIS at Each Visit
Week 25
|
40.09 score on a scale
Standard Deviation 19.547
|
38.08 score on a scale
Standard Deviation 22.658
|
—
|
—
|
—
|
—
|
|
Period 2: Mean TIS at Each Visit
Week 29
|
45.05 score on a scale
Standard Deviation 19.931
|
42.74 score on a scale
Standard Deviation 20.057
|
—
|
—
|
—
|
—
|
|
Period 2: Mean TIS at Each Visit
Week 33
|
44.66 score on a scale
Standard Deviation 19.346
|
46.23 score on a scale
Standard Deviation 18.258
|
—
|
—
|
—
|
—
|
|
Period 2: Mean TIS at Each Visit
Week 37
|
47.81 score on a scale
Standard Deviation 18.805
|
48.49 score on a scale
Standard Deviation 17.071
|
—
|
—
|
—
|
—
|
|
Period 2: Mean TIS at Each Visit
Week 41
|
50.49 score on a scale
Standard Deviation 18.255
|
51.68 score on a scale
Standard Deviation 15.943
|
—
|
—
|
—
|
—
|
|
Period 2: Mean TIS at Each Visit
Week 45
|
50.89 score on a scale
Standard Deviation 19.018
|
52.94 score on a scale
Standard Deviation 15.078
|
—
|
—
|
—
|
—
|
|
Period 2: Mean TIS at Each Visit
Week 49
|
51.63 score on a scale
Standard Deviation 17.844
|
50.51 score on a scale
Standard Deviation 16.010
|
—
|
—
|
—
|
—
|
|
Period 2: Mean TIS at Each Visit
Week 53
|
50.32 score on a scale
Standard Deviation 15.886
|
54.26 score on a scale
Standard Deviation 15.022
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 5, 9, 13, 17, 21, and 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
Participants were considered and reported in more than one category (TIS \>= 20, \>= 40 and \>= 60 Points).
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 5: TIS >= 40 Points
|
16.9 percentage of participants
Interval 8.76 to 28.27
|
15.4 percentage of participants
Interval 7.63 to 26.48
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 5: TIS >= 60 Points
|
1.5 percentage of participants
Interval 0.04 to 8.28
|
1.5 percentage of participants
Interval 0.04 to 8.28
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 9: TIS >= 20 Points
|
63.1 percentage of participants
Interval 50.2 to 74.72
|
56.3 percentage of participants
Interval 43.28 to 68.63
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 9: TIS >= 40 Points
|
32.3 percentage of participants
Interval 21.23 to 45.05
|
26.6 percentage of participants
Interval 16.3 to 39.09
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 9: TIS >= 60 Points
|
9.2 percentage of participants
Interval 3.46 to 19.02
|
4.7 percentage of participants
Interval 0.98 to 13.09
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 13: TIS >= 20 Points
|
73.8 percentage of participants
Interval 61.46 to 83.97
|
60.9 percentage of participants
Interval 47.93 to 72.9
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 13: TIS >= 40 Points
|
36.9 percentage of participants
Interval 25.28 to 49.8
|
31.3 percentage of participants
Interval 20.24 to 44.06
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 13: TIS >= 60 Points
|
13.8 percentage of participants
Interval 6.53 to 24.66
|
10.9 percentage of participants
Interval 4.51 to 21.25
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 17: TIS >= 20 Points
|
75.4 percentage of participants
Interval 63.13 to 85.23
|
57.8 percentage of participants
Interval 44.82 to 70.06
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 17: TIS >= 40 Points
|
44.6 percentage of participants
Interval 32.27 to 57.47
|
34.4 percentage of participants
Interval 22.95 to 47.3
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 17: TIS >= 60 Points
|
15.4 percentage of participants
Interval 7.63 to 26.48
|
15.6 percentage of participants
Interval 7.76 to 26.86
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 21: TIS >= 20 Points
|
73.4 percentage of participants
Interval 60.91 to 83.7
|
60.3 percentage of participants
Interval 47.2 to 72.43
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 21: TIS >= 40 Points
|
53.1 percentage of participants
Interval 40.23 to 65.72
|
33.3 percentage of participants
Interval 21.95 to 46.34
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 21: TIS >= 60 Points
|
18.8 percentage of participants
Interval 10.08 to 30.46
|
12.7 percentage of participants
Interval 5.65 to 23.5
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 25: TIS >= 20 Points
|
64.1 percentage of participants
Interval 51.1 to 75.68
|
65.1 percentage of participants
Interval 52.03 to 76.66
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 25: TIS >= 40 Points
|
45.3 percentage of participants
Interval 32.82 to 58.25
|
39.7 percentage of participants
Interval 27.57 to 52.8
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 25: TIS >= 60 Points
|
17.2 percentage of participants
Interval 8.9 to 28.68
|
15.9 percentage of participants
Interval 7.88 to 27.26
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 5: TIS >= 20 Points
|
47.7 percentage of participants
Interval 35.15 to 60.46
|
47.7 percentage of participants
Interval 35.15 to 60.46
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 25, 29, 33, 37, 41, 45, 49, and 53Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex.
Participants were considered and reported in more than one category (TIS \>= 20, \>= 40 and \>= 60 Points).
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=55 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=54 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 37: TIS >= 20 Points
|
82.7 percentage of participants
Interval 69.67 to 91.77
|
88.5 percentage of participants
Interval 76.56 to 95.65
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 37: TIS >= 40 Points
|
57.7 percentage of participants
Interval 43.2 to 71.27
|
67.3 percentage of participants
Interval 52.89 to 79.67
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 37: TIS >= 60 Points
|
28.8 percentage of participants
Interval 17.13 to 43.08
|
25.0 percentage of participants
Interval 14.03 to 38.95
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 45: TIS >= 40 Points
|
64.0 percentage of participants
Interval 49.19 to 77.08
|
66.7 percentage of participants
Interval 52.08 to 79.24
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 45: TIS >= 60 Points
|
40.0 percentage of participants
Interval 26.41 to 54.82
|
31.4 percentage of participants
Interval 19.11 to 45.89
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 49: TIS >= 20 Points
|
80.0 percentage of participants
Interval 66.28 to 89.97
|
70.0 percentage of participants
Interval 55.39 to 82.14
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 49: TIS >= 40 Points
|
68.0 percentage of participants
Interval 53.3 to 80.48
|
58.0 percentage of participants
Interval 43.21 to 71.81
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 49: TIS >= 60 Points
|
36.0 percentage of participants
Interval 22.92 to 50.81
|
22.0 percentage of participants
Interval 11.53 to 35.96
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 53: TIS >= 20 Points
|
78.0 percentage of participants
Interval 64.04 to 88.47
|
72.0 percentage of participants
Interval 57.51 to 83.77
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 53: TIS >= 40 Points
|
56.0 percentage of participants
Interval 41.25 to 70.01
|
66.0 percentage of participants
Interval 51.23 to 78.79
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 53: TIS >= 60 Points
|
30.0 percentage of participants
Interval 17.86 to 44.61
|
24.0 percentage of participants
Interval 13.06 to 38.17
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 25: TIS >= 20 Points
|
80.0 percentage of participants
Interval 67.03 to 89.57
|
77.8 percentage of participants
Interval 64.4 to 87.96
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 25: TIS >= 40 Points
|
56.4 percentage of participants
Interval 42.32 to 69.7
|
48.1 percentage of participants
Interval 34.34 to 62.16
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 25: TIS >= 60 Points
|
20.0 percentage of participants
Interval 10.43 to 32.97
|
18.5 percentage of participants
Interval 9.25 to 31.43
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 29: TIS >= 20 Points
|
87.0 percentage of participants
Interval 75.1 to 94.63
|
84.9 percentage of participants
Interval 72.41 to 93.25
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 29: TIS >= 40 Points
|
64.8 percentage of participants
Interval 50.62 to 77.32
|
54.7 percentage of participants
Interval 40.45 to 68.44
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 29: TIS >= 60 Points
|
31.5 percentage of participants
Interval 19.52 to 45.55
|
22.6 percentage of participants
Interval 12.28 to 36.21
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 33: TIS >= 20 Points
|
85.2 percentage of participants
Interval 72.88 to 93.38
|
90.6 percentage of participants
Interval 79.34 to 96.87
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 33: TIS >= 40 Points
|
57.4 percentage of participants
Interval 43.21 to 70.77
|
64.2 percentage of participants
Interval 49.8 to 76.86
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 33: TIS >= 60 Points
|
22.2 percentage of participants
Interval 12.04 to 35.6
|
24.5 percentage of participants
Interval 13.76 to 38.28
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 41: TIS >= 20 Points
|
84.3 percentage of participants
Interval 71.41 to 92.98
|
84.6 percentage of participants
Interval 71.92 to 93.12
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 41: TIS >= 40 Points
|
64.7 percentage of participants
Interval 50.07 to 77.57
|
73.1 percentage of participants
Interval 58.98 to 84.43
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 41: TIS >= 60 Points
|
37.3 percentage of participants
Interval 24.13 to 51.92
|
30.8 percentage of participants
Interval 18.72 to 45.1
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Week 45: TIS >= 20 Points
|
80.0 percentage of participants
Interval 66.28 to 89.97
|
84.3 percentage of participants
Interval 71.41 to 92.98
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS
TIS >= 60 Points
|
NA days
Median and 95% CI are not estimable due to an insufficient number of participants with event (TIS \>= 60 points), due to a high number of censored observations.
|
NA days
Interval 170.0 to
Median and upper limit of 95% CI are not estimable due to an insufficient number of participants with event (TIS \>= 60 points), due to a high number of censored observations.
|
—
|
—
|
—
|
—
|
|
Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS
TIS >= 20 Points
|
31.0 days
Interval 28.0 to 56.0
|
32.0 days
Interval 28.0 to 56.0
|
—
|
—
|
—
|
—
|
|
Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS
TIS >= 40 Points
|
112.0 days
Interval 63.0 to 141.0
|
112.0 days
Interval 84.0 to 168.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 53Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS
TIS >= 20 Points
|
31.0 days
Interval 28.0 to 56.0
|
32.0 days
Interval 28.0 to 56.0
|
—
|
—
|
—
|
—
|
|
Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS
TIS >= 40 Points
|
112.0 days
Interval 63.0 to 141.0
|
137.0 days
Interval 84.0 to 196.0
|
—
|
—
|
—
|
—
|
|
Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS
TIS >= 60 Points
|
308.0 days
Interval 196.0 to
Upper limit of CI was not estimable due to an insufficient number of participants with event (TIS \>= 60 points), due to a high number of censored observations.
|
336.0 days
Interval 249.0 to
Upper limit of CI was not estimable due to an insufficient number of participants with event (TIS \>= 60 points), due to a high number of censored observations.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 25Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
Individual CSMs included following: Myositis Disease Activity Assessment Tool (MDAAT) Physician global disease activity (PGDA), PGA assessment, MMT-8, health assessment questionnaire-disability index (HAQ-DI), and MDAAT-EGA. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=52 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=48 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
MMT-8: Week 25
|
10.8 score on a scale
Standard Deviation 16.71
|
15.2 score on a scale
Standard Deviation 24.02
|
—
|
—
|
—
|
—
|
|
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
MDAAT-PGDA: Week 25
|
-21.2 score on a scale
Standard Deviation 19.86
|
-21.8 score on a scale
Standard Deviation 18.64
|
—
|
—
|
—
|
—
|
|
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
MDAAT-EGA: Week 25
|
-17.4 score on a scale
Standard Deviation 22.54
|
-13.9 score on a scale
Standard Deviation 17.67
|
—
|
—
|
—
|
—
|
|
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
PGA: Week 25
|
-13.0 score on a scale
Standard Deviation 26.52
|
-16.8 score on a scale
Standard Deviation 20.57
|
—
|
—
|
—
|
—
|
|
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
HAQ - DI: Week 25
|
-0.195 score on a scale
Standard Deviation 0.4627
|
-0.172 score on a scale
Standard Deviation 0.4801
|
—
|
—
|
—
|
—
|
|
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
CDASI-A: Week 25
|
-11.5 score on a scale
Standard Deviation 10.85
|
-7.9 score on a scale
Standard Deviation 8.91
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 25 to Week 53Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
Individual CSMs included following: MDAAT-PGDA, PGA assessment, MMT-8, HAQ-DI, and MDAAT extramacular global assessment. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=40 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=37 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
MDAAT-PGDA: Week 53
|
-8.5 score on a scale
Standard Deviation 17.13
|
-15.5 score on a scale
Standard Deviation 18.74
|
—
|
—
|
—
|
—
|
|
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
PGA: Week 53
|
-3.3 score on a scale
Standard Deviation 20.94
|
-9.0 score on a scale
Standard Deviation 23.87
|
—
|
—
|
—
|
—
|
|
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
HAQ - DI: Week 53
|
-0.106 score on a scale
Standard Deviation 0.2587
|
-0.162 score on a scale
Standard Deviation 0.4477
|
—
|
—
|
—
|
—
|
|
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
CDASI-A: Week 53
|
-0.8 score on a scale
Standard Deviation 7.52
|
-5.3 score on a scale
Standard Deviation 9.70
|
—
|
—
|
—
|
—
|
|
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
MMT-8: Week 53
|
7.1 score on a scale
Standard Deviation 11.32
|
7.9 score on a scale
Standard Deviation 13.44
|
—
|
—
|
—
|
—
|
|
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
MDAAT-EGA: Week 53
|
-0.9 score on a scale
Standard Deviation 12.38
|
-11.5 score on a scale
Standard Deviation 18.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment Visual Analog Scale (VAS) worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice
More Than Twice
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice
At Least Once
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice
At Least Twice
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
At Least Once
|
3.1 percentage of participants
|
4.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
At Least Twice
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
More Than Twice
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 25 up to Week 53Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex.
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=55 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=54 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice
At Least Once
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice
At Least Twice
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice
More Than Twice
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 25 up to Week 53Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex.
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=55 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=54 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
At Least Once
|
3.6 percentage of participants
|
1.9 percentage of participants
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
At Least Twice
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
More Than Twice
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 53Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The observation was censored if no DOW was observed before the intake of rescue treatment or before the end of the period.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Time to Meeting DOW for the First Time
|
NA days
Median and 95% CI are not estimable due to an insufficient number of participants with event (DOW), due to a high number of censored observations.
|
NA days
Median and 95% CI are not estimable due to an insufficient number of participants with event (DOW), due to a high number of censored observations.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The Number of participants meeting DOW and who received rescue steroid treatment are reported here.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Number of Participants Meeting DOW and Receiving Rescue Steroid Treatment
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The percentage of participants meeting DOW and who received rescue steroid treatment are reported here.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Meeting DOW and Receiving Rescue Steroid Treatment
|
0 percentage of participants
|
3.1 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT. Here, overall number of participants analyzed (N) = participants with oral concomitant corticosteroid treatment at Week 1.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=46 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=48 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Start Oral Corticosteroid Dose Taper
|
19 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT. Here, overall number of participants analyzed (N) = participants with oral concomitant corticosteroid treatment at Week 1.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=46 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=48 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Start Oral Corticosteroid Dose Taper
|
41.3 percentage of participants
|
39.6 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25 and 52Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = all participants with oral concomitant corticosteroid treatment at Week 1 who were part of mITT Ex.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=40 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=39 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 25: Reduction >= 25%
|
16 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 25: Reduction >= 50%
|
11 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 25: Reduction >= 75%
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 52: Reduction >= 25%
|
19 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 52: Reduction >= 50%
|
17 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 52: Reduction >= 75%
|
12 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25 and 52Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = all participants with oral concomitant corticosteroid treatment at Week 1 who were part of mITT Ex.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=40 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=39 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 25: Reduction >= 25%
|
40.0 percentage of participants
|
35.9 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 25: Reduction >= 50%
|
27.5 percentage of participants
|
20.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 25: Reduction >= 75%
|
7.5 percentage of participants
|
7.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 52: Reduction >= 25%
|
47.5 percentage of participants
|
43.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 52: Reduction >= 50%
|
42.5 percentage of participants
|
35.9 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Week 52: Reduction >= 75%
|
30.0 percentage of participants
|
23.1 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Receiving Rescue Corticosteroid Treatment
|
1.5 percentage of participants
|
9.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT. Here, overall number of participants analyzed (N) = participants receiving oral rescue corticosteroid treatment up to Week 25.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=1 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=6 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Whose Rescue Corticosteroid Treatment is Tapered
|
0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 25Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
The observation was censored if no Rescue was observed before the last day of the last week with IMP intake or before the end of the period.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=65 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=65 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Time to First Intake of Rescue Corticosteroid Treatment
|
NA days
Median and 95% CI are not estimable due to an insufficient number of participants with event (intake of rescue treatment), due to a high number of censored observations.
|
NA days
Median and 95% CI are not estimable due to an insufficient number of participants with event (intake of rescue treatment), due to a high number of censored observations.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 13 and 25Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=57 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=55 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Mobility: At least 2 level improvement
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Mobility: More than 2 level improvement
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Self-Care: At least 1 level improvement
|
15 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Self-Care: At least 2 level improvement
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Self-Care: More than 2 level improvement
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Usual Activities: At least 1 level improvement
|
16 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Usual Activities: At least 2 level improvement
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Usual Activities: More than 2 level improvement
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Self-Care: At least 2 level improvement
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Self-Care: More than 2 level improvement
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 13: Mobility: At least 1 level improvement
|
16 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Mobility: At least 1 level improvement
|
10 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Mobility: At least 2 level improvement
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Mobility: More than 2 level improvement
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Self-Care: At least 1 level improvement
|
9 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Usual Activities: At least 1 level improvement
|
15 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Usual Activities: At least 2 level improvement
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
Week 25: Usual Activities: More than 2 level improvement
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Week 13 and 25Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified category.
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=57 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=55 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Self-Care : More than 2 level improvement
|
1.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Usual Activities : At least 1 level improvement
|
28.1 percentage of participants
|
27.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Mobility : At least 1 level improvement
|
19.2 percentage of participants
|
29.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Self-Care : At least 1 level improvement
|
3.8 percentage of participants
|
31.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Usual Activities : At least 1 level improvement
|
15.8 percentage of participants
|
29.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Usual Activities : At least 2 level improvement
|
1.8 percentage of participants
|
5.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Usual Activities : More than 2 level improvement
|
1.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Mobility : At least 2 level improvement
|
9.6 percentage of participants
|
6.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Mobility : More than 2 level improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Self-Care : At least 2 level improvement
|
1.9 percentage of participants
|
6.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Self-Care : More than 2 level improvement
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Usual Activities : At least 2 level improvement
|
5.3 percentage of participants
|
5.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 25: Usual Activities : More than 2 level improvement
|
3.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Mobility : At least 1 level improvement
|
28.1 percentage of participants
|
27.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Mobility : At least 2 level improvement
|
1.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Mobility : More than 2 level improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Self-Care : At least 1 level improvement
|
26.3 percentage of participants
|
23.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 13: Self-Care : At least 2 level improvement
|
3.5 percentage of participants
|
3.6 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 25 to 41 and 53Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified category.
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=47 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=45 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: At least 1 level improvement
|
10 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: At least 2 level improvement
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: At least 2 level improvement
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: At least 2 level improvement
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: At least 1 level improvement
|
10 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: No Reduction
|
29 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: More than 2 level improvement
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: No Reduction
|
32 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: At least 1 level improvement
|
5 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: More than 2 level improvement
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: No Reduction
|
23 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: At least 1 level improvement
|
13 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: At least 2 level improvement
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: More than 2 level improvement
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: No Reduction
|
24 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: At least 1 level improvement
|
8 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: At least 2 level improvement
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: At least 2 level improvement
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: More than 2 level improvement
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: More than 2 level improvement
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: No Reduction
|
33 Participants
|
23 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: At least 1 level improvement
|
2 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: More than 2 level improvement
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: No Reduction
|
21 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 25 to 41 and 53Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified category.
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from "no problems" to "unable to" walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=47 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=45 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: No Reduction
|
60.0 percentage of participants
|
67.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: More than 2 level improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: No Reduction
|
52.5 percentage of participants
|
59.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: No Reduction
|
61.7 percentage of participants
|
62.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: At least 1 level improvement
|
21.3 percentage of participants
|
17.8 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: At least 2 level improvement
|
2.1 percentage of participants
|
2.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Mobility: More than 2 level improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: No Reduction
|
68.1 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: At least 1 level improvement
|
0.6 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: At least 2 level improvement
|
6.4 percentage of participants
|
2.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Self-Care: More than 2 level improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: No Reduction
|
48.9 percentage of participants
|
68.9 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: At least 1 level improvement
|
27.7 percentage of participants
|
22.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: At least 2 level improvement
|
2.1 percentage of participants
|
2.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: At least 2 level improvement
|
5.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 41: Usual Activities: More than 2 level improvement
|
2.1 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: More than 2 level improvement
|
0 percentage of participants
|
2.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Mobility: At least 1 level improvement
|
20.0 percentage of participants
|
18.9 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: No Reduction
|
82.5 percentage of participants
|
62.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: At least 1 level improvement
|
25.0 percentage of participants
|
27.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: At least 1 level improvement
|
5.0 percentage of participants
|
29.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Self-Care: At least 2 level improvement
|
5.0 percentage of participants
|
2.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: At least 2 level improvement
|
7.5 percentage of participants
|
5.4 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
Week 53: Usual Activities: More than 2 level improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Period 1: Safety analysis set (SAF): All randomized participants who received any IMP, analyzed by actual treatment. Period 2: SAF extended (SAF-EX): Participants from SAF who completed 24 weeks in Period 1 and received any IMP in Period 2. Period 3: SAF for SP3 (SAF-P3): Participants from SAF-EX who completed 52 weeks in Periods 1 and 2 and received any IMP after Week 52.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=67 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=67 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
n=56 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
n=55 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
n=36 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
n=34 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs
Related TEAEs
|
52.2 percentage of participants
|
25.4 percentage of participants
|
17.9 percentage of participants
|
43.6 percentage of participants
|
13.9 percentage of participants
|
20.6 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs
TEAEs
|
82.1 percentage of participants
|
67.2 percentage of participants
|
69.6 percentage of participants
|
74.5 percentage of participants
|
75.0 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs
Serious TEAEs
|
4.5 percentage of participants
|
7.5 percentage of participants
|
3.6 percentage of participants
|
5.5 percentage of participants
|
13.9 percentage of participants
|
20.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Period 1: SAF: All randomized participants who received any IMP, analyzed by actual treatment. Period 2: SAF-EX: Participants from SAF who completed 24 weeks in Period 1 and received any IMP in Period 2. Period 3: SAF-P3: Participants from SAF-EX who completed 52 weeks in Periods 1 and 2 and received any IMP after Week 52.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=67 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=67 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
n=56 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
n=55 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
n=36 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
n=34 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk
TEAEs
|
11.725 TEAEs per year
|
5.359 TEAEs per year
|
4.922 TEAEs per year
|
6.718 TEAEs per year
|
3.165 TEAEs per year
|
3.644 TEAEs per year
|
|
Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk
Related TEAEs
|
6.327 TEAEs per year
|
0.936 TEAEs per year
|
1.348 TEAEs per year
|
2.166 TEAEs per year
|
0.195 TEAEs per year
|
0.240 TEAEs per year
|
|
Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk
Serious TEAEs
|
0.214 TEAEs per year
|
0.226 TEAEs per year
|
0.067 TEAEs per year
|
0.110 TEAEs per year
|
0.137 TEAEs per year
|
0.288 TEAEs per year
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Period 1: SAF: All randomized participants who received any IMP, analyzed by actual treatment. Period 2: SAF-EX: Participants from SAF who completed 24 weeks in Period 1 and received any IMP in Period 2. Period 3: SAF-P3: Participants from SAF-EX who completed 52 weeks in Periods 1 and 2 and received any IMP after Week 52.
Outcome measures
| Measure |
Sequence A: IgPro20 / IgPro20
n=67 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Sequence B: Placebo / IgPro20
n=67 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence A: IgPro20 / IgPro20
n=56 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
n=55 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
n=36 Participants
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
n=34 Participants
Participants received matching placebo SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At Week 53, participants with demonstrated treatment benefit at Week 49 (TIS \>= 20 points) continued to Period 3 long-term treatment with open-label IgPro20 SC infusions weekly until the EOS (up to 5 years).
|
|---|---|---|---|---|---|---|
|
Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk
Severe
|
0.393 TEAEs per year
|
0.161 TEAEs per year
|
0.067 TEAEs per year
|
0.110 TEAEs per year
|
0.117 TEAEs per year
|
0.096 TEAEs per year
|
|
Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk
Mild
|
9.151 TEAEs per year
|
4.035 TEAEs per year
|
4.011 TEAEs per year
|
4.332 TEAEs per year
|
2.442 TEAEs per year
|
2.157 TEAEs per year
|
|
Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk
Moderate
|
2.145 TEAEs per year
|
1.162 TEAEs per year
|
0.843 TEAEs per year
|
2.239 TEAEs per year
|
0.606 TEAEs per year
|
1.390 TEAEs per year
|
Adverse Events
Period 1 Sequence A: IgPro20
Serious events: 3 serious events
Other events: 41 other events
Deaths: 1 deaths
Period 1 Sequence B: Placebo
Serious events: 5 serious events
Other events: 33 other events
Deaths: 1 deaths
Period 2 Sequence A: IgPro20 / IgPro20
Serious events: 2 serious events
Other events: 25 other events
Deaths: 1 deaths
Period 2 Sequence B: Placebo / IgPro20
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
Serious events: 7 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Period 1 Sequence A: IgPro20
n=67 participants at risk
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1.
|
Period 1 Sequence B: Placebo
n=67 participants at risk
Participants received albumin solution administered IV to match IgPro20 SC infusions weekly for 24 weeks in Period 1.
|
Period 2 Sequence A: IgPro20 / IgPro20
n=56 participants at risk
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
n=55 participants at risk
Participants received albumin solution administered IV to match IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
n=36 participants at risk
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At the Week 53 visit, eligible participants continued to study Period 3 and continued to receive IgPro20 SC infusions weekly until the end of the study.
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
n=34 participants at risk
Participants received albumin solution administered IV to match IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At the Week 53 visit, eligible participants continued to study Period 3 and continued to receive IgPro20 SC infusions weekly until the end of the study.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Blood and lymphatic system disorders
Pseudolymphoma
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Dermatomyositis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Sudden death
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mueller's mixed tumour
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Vascular disorders
Embolism
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
Other adverse events
| Measure |
Period 1 Sequence A: IgPro20
n=67 participants at risk
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1.
|
Period 1 Sequence B: Placebo
n=67 participants at risk
Participants received albumin solution administered IV to match IgPro20 SC infusions weekly for 24 weeks in Period 1.
|
Period 2 Sequence A: IgPro20 / IgPro20
n=56 participants at risk
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 2 Sequence B: Placebo / IgPro20
n=55 participants at risk
Participants received albumin solution administered IV to match IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2.
|
Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20
n=36 participants at risk
Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At the Week 53 visit, eligible participants continued to study Period 3 and continued to receive IgPro20 SC infusions weekly until the end of the study.
|
Period 3 Sequence B: Placebo / IgPro20 / IgPro20
n=34 participants at risk
Participants received albumin solution administered IV to match IgPro20 SC infusions weekly for 24 weeks in Period 1, followed by IgPro20 SC infusions weekly for 28 weeks in Period 2. At the Week 53 visit, eligible participants continued to study Period 3 and continued to receive IgPro20 SC infusions weekly until the end of the study.
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
2/67 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
6.0%
4/67 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
3/67 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
6.0%
4/67 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
8.9%
5/56 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.5%
3/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
8.8%
3/34 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Gastrointestinal disorders
Nausea
|
9.0%
6/67 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
6.0%
4/67 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Infusion site bruising
|
7.5%
5/67 • Number of events 10 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
6.0%
4/67 • Number of events 10 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 7 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Infusion site erythema
|
17.9%
12/67 • Number of events 47 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
6.0%
4/67 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 12 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
18.2%
10/55 • Number of events 11 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Infusion site nodule
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.4%
3/56 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Infusion site pain
|
6.0%
4/67 • Number of events 10 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
9.1%
5/55 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Infusion site rash
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 8 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Infusion site swelling
|
9.0%
6/67 • Number of events 11 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.5%
3/55 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
General disorders
Pyrexia
|
4.5%
3/67 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.5%
3/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
COVID-19
|
7.5%
5/67 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
6.0%
4/67 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
10.7%
6/56 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
7.3%
4/55 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
36.1%
13/36 • Number of events 13 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
23.5%
8/34 • Number of events 8 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 9 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
4.5%
3/67 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/56 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
9.1%
5/55 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
22.2%
8/36 • Number of events 21 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
17.6%
6/34 • Number of events 16 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.4%
3/56 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
11.8%
4/34 • Number of events 8 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Investigations
Fibrin D dimer increased
|
7.5%
5/67 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
4.5%
3/67 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
8.8%
3/34 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
4/67 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
7.1%
4/56 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
7.5%
5/67 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.5%
3/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
8.3%
3/36 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Dermatomyositis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
7.5%
5/67 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
2/67 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/56 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
7.3%
4/55 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Nervous system disorders
Dizziness
|
7.5%
5/67 • Number of events 6 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/55 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Nervous system disorders
Headache
|
17.9%
12/67 • Number of events 37 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
4.5%
3/67 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.4%
3/56 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.5%
3/55 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
11.1%
4/36 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/34 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Nervous system disorders
Migraine
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/56 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/55 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/67 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
6.0%
4/67 • Number of events 5 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/56 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/55 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.8%
1/36 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.9%
2/34 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
3/67 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.5%
1/67 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
1.8%
1/56 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/55 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
5.6%
2/36 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 1 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
|
Vascular disorders
Hypertension
|
4.5%
3/67 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
4.5%
3/67 • Number of events 3 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
7.1%
4/56 • Number of events 4 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
3.6%
2/55 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
0.00%
0/36 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
2.9%
1/34 • Number of events 2 • Up to 5 years
Analysis was performed on the SAF, which consisted of all participants who were randomized and received any amount of randomized IMP and was based on the actual treatment sequence received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place