Trial Outcomes & Findings for An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (NCT NCT03759288)
NCT ID: NCT03759288
Last Updated: 2026-06-23
Results Overview
CDAI remission is defined as \- CDAI score \< 150 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
89 participants
Primary outcome timeframe
at Week 12
Results posted on
2026-06-23
Participant Flow
As of 1 June 2023, AstraZeneca discontinued the development of brazikumab. All study related dosing was immediately stopped. Because of study early termination, site data cleaning engagement proved challenging and as a result databases were locked with unclean data. A patient centric approach was taken to focus data cleaning on key safety variables (adverse events). Please be aware that the data submitted needs to be considered with the data quality in mind.
Participant milestones
| Measure |
Brazikumab Low Dose
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Adalimumab
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50. Note: The adalimumab group was removed in Amendment 4 version 5.
|
Placebo
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
2
|
18
|
|
Overall Study
COMPLETED
|
4
|
7
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
31
|
24
|
0
|
15
|
Reasons for withdrawal
| Measure |
Brazikumab Low Dose
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Adalimumab
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50. Note: The adalimumab group was removed in Amendment 4 version 5.
|
Placebo
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Overall Study
The reason is either study terminated by the Sponsor, or Unknown.
|
23
|
21
|
0
|
12
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
4
|
1
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Adalimumab 40 mg
n=2 Participants
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 Participants
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 18.69 • n=20 Participants
|
36.5 years
STANDARD_DEVIATION 13.02 • n=20 Participants
|
37.5 years
STANDARD_DEVIATION 6.36 • n=40 Participants
|
42.5 years
STANDARD_DEVIATION 18.16 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 16.64 • n=9 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
55 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
16 Participants
n=5 Participants
|
76 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
13 Participants
n=5 Participants
|
66 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: at Week 12Population: Outcome measure 1 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
CDAI remission is defined as \- CDAI score \< 150 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12Population: Outcome measure 2 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.
Endoscopic response is defined as \- Minimum of 50% decrease from Baseline in SES-CD total score Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12Population: Outcome measure 3 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 25.
Clinical Remission is defined as \- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12Population: Outcome measure 4 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
CDAI response is defined as \- CDAI score of \< 150 points or CDAI reduction from Baseline of ≥ 100 points Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12 and 52Population: Outcome measure 5 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
CDAI remission at both Week 12 and Week 52 is defined as \- CDAI score \< 150 at both Week 12 and 52 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12 and 52Population: Outcome measure 6 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
CDAI response at both Week 12 and Week 52 is defined as \- CDAI score of \< 150 points or CDAI reduction from Baseline of ≥ 100 points at both Week 12 and 52
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12 and 52Population: Outcome measure 7 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.
Endoscopic response at both Week 12 and Week 52 is defined as \- Minimum of 50% decrease from Baseline in SES-CD total score at both Week 12 and 52 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12 and 52Population: Outcome measure 8 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
Clinical remission at both Week 12 and Week 52 is defined as \- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item at both Week 12 and 52
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 52Population: Outcome measure 9 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.
Endoscopic remission is defined as \- SES-CD total score of 0-2, OR SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore \> 1 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 52Population: Outcome measure 10 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
Clinical remission is defined as \- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 52Population: Outcome measure 11 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
CDAI response is defined as \- CDAI score of \< 150 points or CDAI reduction from Baseline of ≥ 100 points Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 52Population: Outcome measure 12 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.
CDAI remission is defined as \- CDAI score \< 150 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 52Population: Outcome measure 13 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.
Endoscopic response is defined as \- Minimum of 50% decrease from Baseline in SES-CD total score Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 52Population: Outcome measure 14 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.
SES-CD total score of 0 - 2 is defined as \- SES-CD total score of 0 - 2 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12 (response) and at Week 52 (remission)Population: Outcome measure 15 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.
Endoscopic response and endoscopic remission is defined as * Endoscopic response at Week 12 and * endoscopic remission at Week 52 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 68 WeeksPopulation: The PK population includes all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
serum concentration of brazikumab
Outcome measures
| Measure |
Adalimumab
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Serum Brazikumab Concentration
Week 16
|
—
|
—
|
38736.890 ng/mL
Standard Deviation 24390.374
|
64005.344 ng/mL
Standard Deviation 32966.081
|
|
Serum Brazikumab Concentration
Baseline (Week 0)
|
—
|
—
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Serum Brazikumab Concentration
Week 4
|
—
|
—
|
39740.393 ng/mL
Standard Deviation 16831.393
|
84159.863 ng/mL
Standard Deviation 45498.163
|
|
Serum Brazikumab Concentration
Week 8
|
—
|
—
|
237241.760 ng/mL
Standard Deviation 176335.398
|
509242.871 ng/mL
Standard Deviation 340284.089
|
|
Serum Brazikumab Concentration
Week 12
|
—
|
—
|
60889.921 ng/mL
Standard Deviation 31963.196
|
126727.906 ng/mL
Standard Deviation 50760.775
|
|
Serum Brazikumab Concentration
Week 24
|
—
|
—
|
32301.477 ng/mL
Standard Deviation 27986.448
|
31530.520 ng/mL
Standard Deviation 19209.280
|
|
Serum Brazikumab Concentration
Week 40
|
—
|
—
|
20446.627 ng/mL
Standard Deviation 12811.061
|
29845.158 ng/mL
Standard Deviation 29196.460
|
SECONDARY outcome
Timeframe: through Week 68Population: The data is reported for the PK population including all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Outcome measures
| Measure |
Adalimumab
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies
Week 52 · Number of subjects without ADA results, n
|
—
|
—
|
30 Participants
|
23 Participants
|
|
Incidence of Anti-drug Antibodies
Week 12 · Number of subjects with any ADA results, n
|
—
|
—
|
32 Participants
|
25 Participants
|
|
Incidence of Anti-drug Antibodies
Week 12 · Positive ADA, n1/n (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Week 12 · nAbs, n2/n1 (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Week 12 · Number of subjects without ADA results, n
|
—
|
—
|
3 Participants
|
6 Participants
|
|
Incidence of Anti-drug Antibodies
Week 52 · nAbs, n2/n1 (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Week 40 · Number of subjects without ADA results, n
|
—
|
—
|
27 Participants
|
17 Participants
|
|
Incidence of Anti-drug Antibodies
Week 52 · Number of subjects with any ADA results, n
|
—
|
—
|
5 Participants
|
8 Participants
|
|
Incidence of Anti-drug Antibodies
Week 52 · Positive ADA, n1/n (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Week 24 · Number of subjects with any ADA results, n
|
—
|
—
|
20 Participants
|
18 Participants
|
|
Incidence of Anti-drug Antibodies
Week 24 · Positive ADA, n1/n (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Week 24 · nAbs, n2/n1 (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Week 24 · Number of subjects without ADA results, n
|
—
|
—
|
15 Participants
|
13 Participants
|
|
Incidence of Anti-drug Antibodies
Week 40 · Number of subjects with any ADA results, n
|
—
|
—
|
8 Participants
|
14 Participants
|
|
Incidence of Anti-drug Antibodies
Week 40 · Positive ADA, n1/n (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Week 40 · nAbs, n2/n1 (%)
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Incidence of Anti-drug Antibodies
Baseline (Week 0) · Number of subjects without ADA results, n
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Incidence of Anti-drug Antibodies
Baseline (Week 0) · nAbs, n2/n1 (%)
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Incidence of Anti-drug Antibodies
Baseline (Week 0) · Number of subjects with any ADA results, n
|
—
|
—
|
34 Participants
|
28 Participants
|
|
Incidence of Anti-drug Antibodies
Baseline (Week 0) · Positive ADA, n1/n (%)
|
—
|
—
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: through Week 68Population: Since the primary endpoint (outcome measure 1) cannot be reported due to the lack of the component based on rescue and prohibited medication, which is defined by adjudication of blinded data, the data for the exposure-response analysis is not available.
Derive exposure-response model linking primary endpoint to metrics of model predicted individual brazikumab exposures.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Week 12Population: Since the serum IL-22 concentration clinical cut-off is derived based on the CDAI remission (outcome measure1) and endoscopic response (outcome measure 2), which cannot be reported due to the lack of the component based on rescue and prohibited medication, defined by adjudication of blinded data, the data for the serum IL-22 concentration clinical cut-off is not available.
Derive the relationship between baseline serum IL-22 concentration and efficacy of brazikumab through CDAI remission and endoscopic response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through Week 68Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
Number and percentage of patients with reported Adverse Events
Outcome measures
| Measure |
Adalimumab
n=2 Participants
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 Participants
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Adverse Events
|
2 Participants
|
13 Participants
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: through Week 68Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
Number and percentage of participants with Potentially Clinically Significant Postbaseline results in hematology, clinical chemistry, and urinalysis.
Outcome measures
| Measure |
Adalimumab
n=2 Participants
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 Participants
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Laboratory Values
Albumin (g/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Albumin (g/L) · Normal
|
2 Participants
|
18 Participants
|
35 Participants
|
29 Participants
|
|
Laboratory Values
Asparate Aminotransferase (ukat/L) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Asparate Aminotransferase (ukat/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Asparate Aminotransferase (ukat/L) · Normal
|
2 Participants
|
17 Participants
|
35 Participants
|
31 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · Low
|
1 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Laboratory Values
Hemoglobin (g/L) · Normal
|
1 Participants
|
14 Participants
|
29 Participants
|
28 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · High
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Leukocytes (10^9/L) · Normal
|
2 Participants
|
17 Participants
|
34 Participants
|
31 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · Low
|
0 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
|
Laboratory Values
Lymphocytes/Leukocytes (%) · Normal
|
2 Participants
|
12 Participants
|
29 Participants
|
29 Participants
|
|
Laboratory Values
Neutrophils/Leukocytes · High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Neutrophils/Leukocytes · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Neutrophils/Leukocytes · Normal
|
2 Participants
|
18 Participants
|
34 Participants
|
31 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Alanine Aminotransferase (ukat/L) · Normal
|
2 Participants
|
17 Participants
|
35 Participants
|
31 Participants
|
|
Laboratory Values
Albumin (g/L) · High
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Laboratory Values
Glucose (mmol/L) · High
|
1 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Laboratory Values
Glucose (mmol/L) · Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Glucose (mmol/L) · Normal
|
1 Participants
|
15 Participants
|
27 Participants
|
29 Participants
|
|
Laboratory Values
Magnesium (mmol/L) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Magnesium (mmol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Magnesium (mmol/L) · Normal
|
2 Participants
|
17 Participants
|
35 Participants
|
31 Participants
|
|
Laboratory Values
Protein (g/L) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Protein (g/L) · Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Protein (g/L) · Normal
|
2 Participants
|
16 Participants
|
35 Participants
|
31 Participants
|
|
Laboratory Values
Urate (umol/L) · High
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Laboratory Values
Urate (umol/L) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urate (umol/L) · Normal
|
1 Participants
|
18 Participants
|
35 Participants
|
29 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · High
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Glucose (Arbitrary U) · Normal
|
1 Participants
|
17 Participants
|
34 Participants
|
31 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · High
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Ketone Bodies (Arbitrary U) · Normal
|
2 Participants
|
17 Participants
|
33 Participants
|
30 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · High
|
0 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Leukocyte Esterase (Arbitrary U) · Normal
|
2 Participants
|
16 Participants
|
28 Participants
|
29 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Nitrite (Arbitrary U) · Normal
|
2 Participants
|
17 Participants
|
35 Participants
|
31 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · High
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory Values
Urine Protein (Arbitrary U) · Normal
|
2 Participants
|
18 Participants
|
33 Participants
|
30 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · High
|
1 Participants
|
8 Participants
|
14 Participants
|
10 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Laboratory Values
Urine Specific Gravity (RATIO) · Normal
|
1 Participants
|
10 Participants
|
20 Participants
|
21 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · Low
|
1 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Laboratory Values
Hematocrit (RATIO) · Normal
|
1 Participants
|
14 Participants
|
30 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: through Week 68Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
Number and percentage of participants with Potentially Clinically Significant Postbaseline results in systolic, diastolic pulse rate.
Outcome measures
| Measure |
Adalimumab
n=2 Participants
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 Participants
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · High
|
0 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vital Signs
Sitting systolic blood pressure (mmHg) · Normal
|
2 Participants
|
15 Participants
|
31 Participants
|
26 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · High
|
0 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Low
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Vital Signs
Sitting diastolic blood pressure (mmHg) · Normal
|
2 Participants
|
16 Participants
|
24 Participants
|
24 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · High
|
0 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Low
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Vital Signs
Sitting pulse rate (bpm) · Normal
|
2 Participants
|
14 Participants
|
27 Participants
|
24 Participants
|
|
Vital Signs
Weight (kg) · High
|
0 Participants
|
2 Participants
|
9 Participants
|
10 Participants
|
|
Vital Signs
Weight (kg) · Low
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Vital Signs
Weight (kg) · Normal
|
2 Participants
|
14 Participants
|
25 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: through Week 68Population: The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
Number and percentage of participants with Potentially Clinically Significant Postbaseline results in 12-lead ECG recordings.
Outcome measures
| Measure |
Adalimumab
n=2 Participants
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 Participants
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
ECGs
|
1 Participants
|
6 Participants
|
7 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through Week 68Population: Any new or aggravated clinically relevant abnormal medical finding occurring at a physical examination (PE) as compared with the Baseline assessment was considered as a treatment emergent adverse event and is reported in the Adverse Event section. No data related to the PE was captured and it was not captured for the adverse events if it was related to a PE. Since it was never collected it is not possible to report either any PE data or the AEs related to a PE separately.
Physical examination as safety assessment, to facilitate the evaluation of the safety objective (Adverse Events).
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: at Week 12 and at Week 52Population: Since the pre-specified outcome measure based on the CDAI score cannot be reported due to the lack of the component based on rescue and prohibited medication, which is defined by adjudication of blinded data, the CDAI score is reported since that is the data assessed and available.
Mean CDAI score at Baseline, Week 12, and Change from Baseline
Outcome measures
| Measure |
Adalimumab
n=18 Participants
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Mean CDAI Score
CDAI score at Baseline
|
308.7 score
Standard Deviation 49.52
|
—
|
325.7 score
Standard Deviation 64.76
|
308.2 score
Standard Deviation 62.37
|
|
Mean CDAI Score
CDAI score at Week 12
|
193.6 score
Standard Deviation 88.17
|
—
|
212.7 score
Standard Deviation 145.03
|
148.7 score
Standard Deviation 91.65
|
|
Mean CDAI Score
Change from Baseline to Week 12
|
-112.7 score
Standard Deviation 81.03
|
—
|
-109.0 score
Standard Deviation 142.99
|
-152.2 score
Standard Deviation 122.73
|
|
Mean CDAI Score
CDAI score at Week 52
|
7.0 score
Standard Deviation 0
|
—
|
196.0 score
Standard Deviation 0
|
62.4 score
Standard Deviation 72.16
|
|
Mean CDAI Score
Change from Baseline to Week 52
|
-229.0 score
Standard Deviation 0
|
—
|
-276.0 score
Standard Deviation 0
|
-245.2 score
Standard Deviation 78.33
|
POST_HOC outcome
Timeframe: at Week 12 and at Week 52Population: Since the pre-specified outcome measure based on the SES-CD score cannot be reported due to the lack of the component based on rescue and prohibited medication, which is defined by adjudication of blinded data, the SES-CD score is reported since that is the data assessed and available.
SES-CD component and total scores at Baseline and Week 12
Outcome measures
| Measure |
Adalimumab
n=2 Participants
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 Participants
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
Brazikumab Low Dose
n=35 Participants
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 Participants
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Mean SES-CD Scores
SES-CD score of rectum at Baseline
|
3.0 score
Standard Deviation 0
|
2.2 score
Standard Deviation 2.69
|
2.5 score
Standard Deviation 2.96
|
1.9 score
Standard Deviation 2.47
|
|
Mean SES-CD Scores
SES-CD score of rectum at Week 12
|
2.5 score
Standard Deviation 3.54
|
1.6 score
Standard Deviation 2.91
|
1.8 score
Standard Deviation 2.72
|
0.9 score
Standard Deviation 1.69
|
|
Mean SES-CD Scores
Change from Baseline to Week 12 for rectum
|
-0.5 score
Standard Deviation 3.54
|
-0.6 score
Standard Deviation 2.11
|
-0.9 score
Standard Deviation 1.83
|
-0.9 score
Standard Deviation 2.29
|
|
Mean SES-CD Scores
SES-CD score of left colon at Baseline
|
2.0 score
Standard Deviation 2.83
|
2.6 score
Standard Deviation 3.01
|
2.1 score
Standard Deviation 2.66
|
2.5 score
Standard Deviation 2.79
|
|
Mean SES-CD Scores
SES-CD score of left colon at Week 12
|
2.0 score
Standard Deviation 2.83
|
2.1 score
Standard Deviation 3.29
|
1.6 score
Standard Deviation 2.50
|
0.6 score
Standard Deviation 1.72
|
|
Mean SES-CD Scores
Change from Baseline to Week 12 for left colon
|
0 score
Standard Deviation 0.0
|
-0.8 score
Standard Deviation 2.29
|
-0.6 score
Standard Deviation 1.48
|
-2.2 score
Standard Deviation 2.62
|
|
Mean SES-CD Scores
SES-CD score of transverse colon at Baseline
|
2.0 score
Standard Deviation 2.83
|
1.1 score
Standard Deviation 1.64
|
1.6 score
Standard Deviation 2.20
|
2.3 score
Standard Deviation 2.73
|
|
Mean SES-CD Scores
SES-CD score of transverse colon at Week 12
|
1.5 score
Standard Deviation 2.12
|
1.4 score
Standard Deviation 2.78
|
1.2 score
Standard Deviation 2.52
|
0.8 score
Standard Deviation 1.75
|
|
Mean SES-CD Scores
Change from Baseline to Week 12 for transverse colon
|
-0.5 score
Standard Deviation 0.71
|
0.5 score
Standard Deviation 2.66
|
-0.6 score
Standard Deviation 2.62
|
-1.7 score
Standard Deviation 2.40
|
|
Mean SES-CD Scores
SES-CD score of right colon at Baseline
|
1.5 score
Standard Deviation 2.12
|
2.2 score
Standard Deviation 2.33
|
3.5 score
Standard Deviation 2.19
|
3.3 score
Standard Deviation 2.63
|
|
Mean SES-CD Scores
SES-CD score of right colon at Week 12
|
3.0 score
Standard Deviation 0.0
|
2.9 score
Standard Deviation 4.18
|
2.0 score
Standard Deviation 2.44
|
1.6 score
Standard Deviation 2.48
|
|
Mean SES-CD Scores
Change from Baseline to Week 12 for right colon
|
1.5 score
Standard Deviation 2.12
|
1.2 score
Standard Deviation 4.42
|
-1.6 score
Standard Deviation 2.44
|
-1.3 score
Standard Deviation 2.47
|
|
Mean SES-CD Scores
SES-CD score of ileum at Baseline
|
2.0 score
Standard Deviation 2.83
|
5.8 score
Standard Deviation 3.45
|
4.3 score
Standard Deviation 3.21
|
4.0 score
Standard Deviation 2.94
|
|
Mean SES-CD Scores
SES-CD score of ileum at Week 12
|
0 score
Standard Deviation 0.0
|
5.2 score
Standard Deviation 4.18
|
2.4 score
Standard Deviation 2.78
|
3.6 score
Standard Deviation 3.85
|
|
Mean SES-CD Scores
Change from Baseline to Week 12 for ileum
|
-2.0 score
Standard Deviation 2.83
|
-0.6 score
Standard Deviation 1.41
|
-1.0 score
Standard Deviation 2.31
|
-0.7 score
Standard Deviation 2.00
|
|
Mean SES-CD Scores
Total SES-CD score at Baseline
|
10.5 score
Standard Deviation 0.71
|
13.1 score
Standard Deviation 6.38
|
13.6 score
Standard Deviation 6.93
|
13.2 score
Standard Deviation 6.70
|
|
Mean SES-CD Scores
Total SES-CD score at Week 12
|
9.0 score
Standard Deviation 8.49
|
11.3 score
Standard Deviation 6.50
|
7.8 score
Standard Deviation 6.81
|
6.9 score
Standard Deviation 6.83
|
|
Mean SES-CD Scores
Change from Baseline to Week 12 for Total Score
|
-1.5 score
Standard Deviation 7.78
|
-1.3 score
Standard Deviation 4.85
|
-6.1 score
Standard Deviation 6.44
|
-6.2 score
Standard Deviation 9.00
|
|
Mean SES-CD Scores
SES-CD score of rectum at Week 52
|
2.5 score
Standard Deviation 3.54
|
0.0 score
Standard Deviation 0
|
0.0 score
Standard Deviation 0
|
0.1 score
Standard Deviation 0.35
|
|
Mean SES-CD Scores
Change from Baseline to Week 52 for score of rectum
|
-0.5 score
Standard Deviation 3.54
|
0 score
Standard Deviation 0
|
-1.7 score
Standard Deviation 2.66
|
-1.6 score
Standard Deviation 1.77
|
|
Mean SES-CD Scores
SES-CD score of left colon at Week 52
|
3.5 score
Standard Deviation 3.54
|
0.0 score
Standard Deviation 0
|
0.0 score
Standard Deviation 0
|
1.0 score
Standard Deviation 1.85
|
|
Mean SES-CD Scores
Change from Baseline to Week 52 for score of left colon
|
1.5 score
Standard Deviation 0.71
|
0.0 score
Standard Deviation 0
|
-1.8 score
Standard Deviation 2.56
|
-1.9 score
Standard Deviation 3.44
|
|
Mean SES-CD Scores
SES-CD score of transverse colon at Week 52
|
3.0 score
Standard Deviation 4.24
|
0.0 score
Standard Deviation 0
|
0.5 score
Standard Deviation 1.22
|
0.0 score
Standard Deviation 0
|
|
Mean SES-CD Scores
Change from Baseline to Week 52 for score of transverse colon
|
1.0 score
Standard Deviation 1.41
|
0.0 score
Standard Deviation 0
|
-0.8 score
Standard Deviation 1.17
|
-2.5 score
Standard Deviation 2.67
|
|
Mean SES-CD Scores
SES-CD score of right colon at Week 52
|
2.5 score
Standard Deviation 3.54
|
0.0 score
Standard Deviation 0
|
1.2 score
Standard Deviation 2.86
|
0.9 score
Standard Deviation 1.64
|
|
Mean SES-CD Scores
Change from Baseline to Week 52 for score of right colon
|
1.0 score
Standard Deviation 5.66
|
-1.5 score
Standard Deviation 2.12
|
-2.5 score
Standard Deviation 3.02
|
-2.6 score
Standard Deviation 3.20
|
|
Mean SES-CD Scores
SES-CD score of ileum at Week 52
|
1.5 score
Standard Deviation 2.12
|
7.7 score
Standard Deviation 3.06
|
1.4 score
Standard Deviation 1.95
|
2.6 score
Standard Deviation 3.78
|
|
Mean SES-CD Scores
Change from Baseline to Week 52 for score of ileum
|
-0.5 score
Standard Deviation 0.71
|
2.0 score
Standard Deviation 1.73
|
-2.6 score
Standard Deviation 2.61
|
-2.4 score
Standard Deviation 2.51
|
|
Mean SES-CD Scores
Total SES-CD score at Week 52
|
13.0 score
Standard Deviation 12.73
|
7.7 score
Standard Deviation 3.06
|
2.8 score
Standard Deviation 2.64
|
4.6 score
Standard Deviation 4.69
|
|
Mean SES-CD Scores
Change from Baseline to Week 52 in Total SES-CD score
|
2.5 score
Standard Deviation 12.02
|
1.0 score
Standard Deviation 3.00
|
-11.0 score
Standard Deviation 6.90
|
-9.6 score
Standard Deviation 11.41
|
Adverse Events
Brazikumab Low Dose
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Brazikumab High Dose
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Adalimumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brazikumab Low Dose
n=35 participants at risk
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 participants at risk
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Adalimumab
n=2 participants at risk
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 participants at risk
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Infections and infestations
Herpes zoster
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorders
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
Other adverse events
| Measure |
Brazikumab Low Dose
n=35 participants at risk
IV brazikumab 720 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Brazikumab High Dose
n=31 participants at risk
IV brazikumab 1440 mg on Days 1, 29, and 57, followed by SC brazikumab 240 mg on Day 85 and every 4 weeks through Week 48
|
Adalimumab
n=2 participants at risk
SC adalimumab 160 mg on Day 1, 80 mg on Day 15, and 40 mg beginning on Day 29 and every 2 weeks through Week 50
|
Placebo
n=18 participants at risk
IV placebo on Days 1, 29, and 57, followed by SC placebo on Day 85 and every 4 weeks through Week 48
|
|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
50.0%
1/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Abdominal mass
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.6%
3/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
11.1%
2/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Gastro mucosal lesion
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Haematochezia
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Intestinal fistula
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
6.5%
2/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
50.0%
1/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
3/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
50.0%
1/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
3/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Renal and urinary disorders
Haematuria
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Renal and urinary disorders
Renal colic
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Fatigue
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Injection site erythema
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Injection site pruritus
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Malaise
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Pain
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
General disorders
Pyrexia
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Investigations
Crystal urine present
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
50.0%
1/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Abscess
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
11.1%
2/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
COVID-19
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
16.7%
3/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Chlamydial infection
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Clostridium difficile infection
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Fungal infection
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Furuncle
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Gastrointestinal viral infection
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Herpes zoster
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
5/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
6.5%
2/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
50.0%
1/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
11.1%
2/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Oral Candidiasis
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Paronychia
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Pharyngitis
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Vaginal infection
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
11.1%
2/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
6.5%
2/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
5.6%
1/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Psychiatric disorders
Anxiety
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Nervous system disorders
Hypoaesthesia
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Eye disorders
Blepharitis
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Eye disorders
Vision blurred
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
50.0%
1/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/35 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
3.2%
1/31 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/2 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
0.00%
0/18 • Through week 66
The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place