Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC) (NCT NCT06137183)
NCT ID: NCT06137183
Last Updated: 2026-02-24
Results Overview
Clinical remission was defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore=0, \& endoscopy subscore ≤ 1 (score of 1 modified to exclude friability). MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease: stool frequency (0=Normal number of stools, 1=1-2 more stools than normal, 2=3-4 more stools than normal, 3=5 or more stools than normal); rectal bleeding (0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed); centrally read endoscopy (0=Normal appearance of mucosa, 1=Mild disease \[erythema, decreased vascular pattern\], 2=Moderate disease \[marked erythema, absent vascular pattern, friability, erosions\], 3=Severe disease \[spontaneous bleeding, ulceration\]). Percentages have been rounded off.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
At Week 12
Results posted on
2026-02-24
Participant Flow
A total of 79 participants with active moderate to severe ulcerative colitis (UC) took part in the study at 43 centers across 12 countries from 1 May 2024 to 16 June 2025.
Participants were randomized in a 1:1:1 ratio to 3 cohorts \& received Vixarelimab, every 2 weeks (Q2W); Vixarelimab, every 4 weeks (Q4W), or Placebo, Q2W. The study was divided into two periods: Induction period and an optional Active Treatment Extension (ATE) period. Participants who completed the induction period could optionally continue treatment in the ATE period.
Participant milestones
| Measure |
Arm A: Vixarelimab 720 mg Q2W
Participants received vixarelimab, 720 milligrams (mg), subcutaneously (SC), at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Induction Period
NOT COMPLETED
|
12
|
16
|
9
|
0
|
0
|
0
|
|
Induction Period
STARTED
|
27
|
26
|
26
|
0
|
0
|
0
|
|
Induction Period
COMPLETED
|
15
|
10
|
17
|
0
|
0
|
0
|
|
Optional ATE Period
STARTED
|
0
|
0
|
0
|
15
|
10
|
17
|
|
Optional ATE Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Optional ATE Period
NOT COMPLETED
|
0
|
0
|
0
|
15
|
10
|
17
|
Reasons for withdrawal
| Measure |
Arm A: Vixarelimab 720 mg Q2W
Participants received vixarelimab, 720 milligrams (mg), subcutaneously (SC), at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Induction Period
Adverse Event
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Induction Period
Disease Relapse
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period
Lack of Efficacy
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period
Progressive Disease
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period
Study Terminated by Sponsor
|
7
|
9
|
8
|
0
|
0
|
0
|
|
Induction Period
Withdrawal by Subject
|
4
|
2
|
0
|
0
|
0
|
0
|
|
Optional ATE Period
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Optional ATE Period
Disease Relapse
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Optional ATE Period
Lack of Efficacy
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Optional ATE Period
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Optional ATE Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
11
|
9
|
14
|
|
Optional ATE Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Baseline characteristics by cohort
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 Participants
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 15.4 • n=58 Participants
|
45.5 years
STANDARD_DEVIATION 18.0
|
40.6 years
STANDARD_DEVIATION 14.9 • n=1 Participants
|
43.4 years
STANDARD_DEVIATION 16.0 • n=484 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=58 Participants
|
7 Participants
|
14 Participants
n=1 Participants
|
35 Participants
n=484 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=58 Participants
|
19 Participants
|
12 Participants
n=1 Participants
|
44 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=58 Participants
|
2 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=58 Participants
|
23 Participants
|
23 Participants
n=1 Participants
|
73 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
1 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=484 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=58 Participants
|
3 Participants
|
6 Participants
n=1 Participants
|
13 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=58 Participants
|
1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=484 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=58 Participants
|
20 Participants
|
20 Participants
n=1 Participants
|
63 Participants
n=484 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=484 Participants
|
PRIMARY outcome
Timeframe: At Week 12Population: mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment.
Clinical remission was defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore=0, \& endoscopy subscore ≤ 1 (score of 1 modified to exclude friability). MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease: stool frequency (0=Normal number of stools, 1=1-2 more stools than normal, 2=3-4 more stools than normal, 3=5 or more stools than normal); rectal bleeding (0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed); centrally read endoscopy (0=Normal appearance of mucosa, 1=Mild disease \[erythema, decreased vascular pattern\], 2=Moderate disease \[marked erythema, absent vascular pattern, friability, erosions\], 3=Severe disease \[spontaneous bleeding, ulceration\]). Percentages have been rounded off.
Outcome measures
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 Participants
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Remission at Week 12
|
11.1 percentage of participants
Interval 3.85 to 28.06
|
3.8 percentage of participants
Interval 0.68 to 18.89
|
11.5 percentage of participants
Interval 4.0 to 28.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment.
Clinical response was defined as decrease from baseline in mMS of ≥ 2 \& ≥ 30% reduction from baseline and also decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease. Rectal bleeding scores are: 0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed. Percentages have been rounded off.
Outcome measures
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 Participants
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Response at Week 12
|
29.6 percentage of participants
Interval 15.85 to 48.48
|
19.2 percentage of participants
Interval 8.51 to 37.88
|
26.9 percentage of participants
Interval 13.7 to 46.08
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment.
Endoscopic improvement was defined as a Mayo endoscopy subscore of ≤ 1 (score of 1 modified to exclude friability). Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation \[erythema, decreased vascular pattern\]; 2=Moderate inflammation \[marked erythema, absent vascular pattern, and friability\]; 3= Severe inflammation \[ulceration and spontaneous bleeding\]), with higher scores indicating more severe disease. Percentages have been rounded off.
Outcome measures
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 Participants
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Improvement at Week 12
|
11.1 percentage of participants
Interval 3.85 to 28.06
|
3.8 percentage of participants
Interval 0.68 to 18.89
|
19.2 percentage of participants
Interval 8.51 to 37.88
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment.
Endoscopic remission was defined as a Mayo endoscopy subscore of 0. Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation \[erythema, decreased vascular pattern and mild friability\]; 2=Moderate inflammation \[marked erythema, absent vascular pattern, and friability\]; 3= Severe inflammation \[ulceration and spontaneous bleeding\]), with higher scores indicating more severe disease. Percentages have been rounded off.
Outcome measures
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 Participants
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Remission at Week 12
|
0 percentage of participants
Interval 0.0 to 12.46
|
0 percentage of participants
Interval 0.0 to 12.87
|
7.7 percentage of participants
Interval 2.14 to 24.14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)Population: Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; Any new disease or exacerbation of existing disease; Recurrence of an intermittent medical condition not present at baseline; Any deterioration in a laboratory value or other clinical test, associated with symptoms or leads to change in study treatment or concomitant treatment or discontinuation from study treatment; AEs related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.
Outcome measures
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 Participants
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
n=15 Participants
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
n=10 Participants
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
n=17 Participants
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
13 Participants
|
14 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks)Population: Pharmacokinetic (PK)-evaluable population included all participants with at least one post-dose serum PK sample in which vixarelimab concentration was evaluable. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Outcome measures
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=25 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=25 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Vixarelimab at Specified Timepoints
Week 0
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not estimable as samples were less than reportable (LTR).
|
NA micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not estimable as samples were LTR.
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Vixarelimab at Specified Timepoints
Week 1
|
62.9 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 39.9
|
66.0 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 45.2
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Vixarelimab at Specified Timepoints
Week 2
|
126 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 41.9
|
112 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 62.9
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Vixarelimab at Specified Timepoints
Week 4
|
127 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 59.5
|
74.5 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 65.7
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Vixarelimab at Specified Timepoints
Week 8
|
135 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 64.9
|
44.2 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 110.2
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Vixarelimab at Specified Timepoints
Week 12
|
143 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 53.4
|
46.2 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 86.6
|
—
|
—
|
—
|
—
|
|
Serum Concentration of Vixarelimab at Specified Timepoints
Study Completion/Early Termination
|
123 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 51.3
|
74.0 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 68.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and post-baseline visits (up to 12 weeks)Population: Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to vixarelimab was determined by summing the ADA-positive participants across all timepoints.
Outcome measures
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=25 Participants
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Induction: Number of Participants With Anti-drug Antibodies (ADAs)
Baseline
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Induction: Number of Participants With Anti-drug Antibodies (ADAs)
Post-baseline
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Arm A: Vixarelimab 720 mg Q2W
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm B: Vixarelimab 720 mg Q4W
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm C: Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm C: Placebo to Vixarelimab 720 mg Q2W
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 participants at risk
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 participants at risk
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 participants at risk
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
n=15 participants at risk
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
n=10 participants at risk
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
n=17 participants at risk
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
3.8%
1/26 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
3.8%
1/26 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
Other adverse events
| Measure |
Arm A: Vixarelimab 720 mg Q2W
n=27 participants at risk
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm B: Vixarelimab 720 mg Q4W
n=26 participants at risk
Participants received vixarelimab, 720 mg, SC, at Weeks 0, 1, 4, and Q4W thereafter, along with placebo, SC, at Week 2 and Q4W up to Week 12 during the induction period. Participants received a placebo at Week 2 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo
n=26 participants at risk
Participants received placebo, SC, at Weeks 0, 1, 2, and Q2W thereafter, up to Week 12 during the induction period.
|
Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W
n=15 participants at risk
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter, for up to Week 46.
|
Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W
n=10 participants at risk
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q4W thereafter, up to Week 46. Participants received placebo at Week 14 and Q4W thereafter to maintain blind between Q2W and Q4W regimens.
|
Arm C: Placebo to Vixarelimab 720 mg Q2W
n=17 participants at risk
After completion of induction treatment, participants who entered the optional ATE period continued to receive vixarelimab, 720 mg, SC, at Week 12 and Q2W thereafter up to Week 46.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
7.4%
2/27 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
11.5%
3/26 • Number of events 3 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
11.8%
2/17 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
General disorders
Oedema
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
General disorders
Peripheral swelling
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Eye infection
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
1/27 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Periodontitis
|
3.7%
1/27 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Viral infection
|
3.7%
1/27 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.7%
1/27 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
3.8%
1/26 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.7%
1/27 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
7.7%
2/26 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
13.3%
2/15 • Number of events 2 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
General disorders
Drug intolerance
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
5.9%
1/17 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Gastrointestinal disorders
Administration site reaction
|
0.00%
0/27 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
6.7%
1/15 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/10 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
|
Infections and infestations
Gastrointestinal Infection
|
3.7%
1/27 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/26 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/15 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
10.0%
1/10 • Number of events 1 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
0.00%
0/17 • Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks)
Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER