Trial Outcomes & Findings for A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (NCT NCT04791319)
NCT ID: NCT04791319
Last Updated: 2023-03-01
Results Overview
Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
199 participants
Primary outcome timeframe
Week 16
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.
|
Bermekimab 350 mg
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15.
|
Bermekimab 700 mg
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15.
|
Dupilumab
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14.
|
Placebo Then Bermekimab 700 mg
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg Then Bermekimab 350 mg
After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Placebo Controlled Period (Week 0-15)
STARTED
|
33
|
33
|
67
|
66
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-15)
Treated
|
33
|
33
|
67
|
65
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-15)
COMPLETED
|
19
|
21
|
30
|
38
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-15)
NOT COMPLETED
|
14
|
12
|
37
|
28
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Active Treatment Period (Week 16-31)
STARTED
|
0
|
0
|
0
|
0
|
19
|
21
|
22
|
3
|
5
|
27
|
11
|
|
Active Treatment Period (Week 16-31)
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
6
|
3
|
1
|
1
|
6
|
2
|
|
Active Treatment Period (Week 16-31)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
18
|
15
|
19
|
2
|
4
|
21
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.
|
Bermekimab 350 mg
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15.
|
Bermekimab 700 mg
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15.
|
Dupilumab
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14.
|
Placebo Then Bermekimab 700 mg
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg Then Bermekimab 350 mg
After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Placebo Controlled Period (Week 0-15)
Withdrawal by Subject
|
4
|
2
|
9
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-15)
Lost to Follow-up
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-15)
Trial termination
|
2
|
4
|
5
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-15)
Participants who completed only safety follow-up
|
7
|
6
|
21
|
19
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-15)
Not treated
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Active Treatment Period (Week 16-31)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
0
|
0
|
0
|
3
|
|
Active Treatment Period (Week 16-31)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Active Treatment Period (Week 16-31)
Trial termination and COVID-19 related
|
0
|
0
|
0
|
0
|
4
|
5
|
2
|
0
|
1
|
9
|
2
|
|
Active Treatment Period (Week 16-31)
Participants who completed safety follow-up
|
0
|
0
|
0
|
0
|
12
|
8
|
16
|
2
|
3
|
11
|
4
|
Baseline Characteristics
A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=33 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=33 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=67 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=65 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 14.18 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 13.32 • n=7 Participants
|
36 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 15.02 • n=4 Participants
|
36 years
STANDARD_DEVIATION 13.65 • n=21 Participants
|
|
Age, Customized
From 18 to 64 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
|
Age, Customized
From 65 to 84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
185 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
142 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
CANADA
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Region of Enrollment
GERMANY
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Region of Enrollment
JAPAN
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
POLAND
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Region of Enrollment
UNITED STATES
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The modified full analysis set (mFAS) included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.
Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=24 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=42 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=43 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16
|
9.5 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
51.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The mFAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.
Percentage of participants achieving vIGA-AD at Week 16 were reported. It is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher score indicated more severity of AD.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=24 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=42 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=43 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
|
9.5 percentage of participants
|
12.5 percentage of participants
|
11.9 percentage of participants
|
27.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The mFAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Percentage of participants with improvement (reduction from baseline) in eczema-related itch NRS of score \>=4 at Week 16 among participants with a baseline itch value \>=4 were reported. The eczema skin pain and Itch NRS is a 2-item patient-reported outcome that participants used to rate the severity of their eczema-related skin pain and eczema related itch daily. Participants were asked the following questions: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours; and please rate the severity of your eczema-related itch at its worst in the past 24 hours. Each item was on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible" and were scored separately. Higher score indicated more severity.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=20 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=32 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=34 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction From Baseline) in Eczema-Related Itch Numeric Rating Scale (NRS) of Score >=4 at Week 16 Among Participants With a Baseline Itch Value >=4
|
10.5 percentage of participants
|
20.0 percentage of participants
|
6.3 percentage of participants
|
32.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: The mFAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.
Percentage of participants achieving EASI-90 at Week 16 were reported. EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=24 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=42 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=43 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving EASI-90 (>= 90% Improvement in EASI From Baseline) at Week 16
|
9.5 percentage of participants
|
12.5 percentage of participants
|
11.9 percentage of participants
|
34.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 36Population: The safety analysis set included all participants who had received at least 1 dose of study intervention.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were AEs with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline. AEs are presented by individual dose received by participants during placebo-controlled period and by responders individual dose received during active treatment period.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=33 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=67 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=65 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
n=19 Participants
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
n=5 Participants
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
n=11 Participants
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
18 Participants
|
26 Participants
|
46 Participants
|
40 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 36Population: The safety analysis set included all participants who had received at least 1 dose of study intervention.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any SAE with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline was considered to be TESAEs. AEs are presented by individual dose received by participants during placebo-controlled period and active treatment period.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=33 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=67 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=65 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
n=19 Participants
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
n=21 Participants
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
n=22 Participants
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
n=3 Participants
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
n=5 Participants
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
n=27 Participants
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
n=11 Participants
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose at Week 0, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, and Week 36Population: The pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of bermekimab and had at least 1 valid blood sample drawn for PK analysis. Here, "n (number analyzed)" specifies number of participants who were analyzed at the specified timepoint and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Serum bermekimab concentration over time were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=33 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=22 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=3 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
n=5 Participants
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Bermekimab Concentration Over Time
Week 0
|
—
|
0.00 micrograms per mililiters (mcg/mL)
Standard Deviation 0.000
|
0.00 micrograms per mililiters (mcg/mL)
Standard Deviation 0.000
|
0.00 micrograms per mililiters (mcg/mL)
Standard Deviation 0.000
|
0.00 micrograms per mililiters (mcg/mL)
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 1
|
—
|
24.80 micrograms per mililiters (mcg/mL)
Standard Deviation 10.156
|
44.61 micrograms per mililiters (mcg/mL)
Standard Deviation 16.945
|
36.88 micrograms per mililiters (mcg/mL)
Standard Deviation 2.831
|
34.96 micrograms per mililiters (mcg/mL)
Standard Deviation 11.796
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 4
|
—
|
37.85 micrograms per mililiters (mcg/mL)
Standard Deviation 19.347
|
75.65 micrograms per mililiters (mcg/mL)
Standard Deviation 35.815
|
83.07 micrograms per mililiters (mcg/mL)
Standard Deviation 46.927
|
71.15 micrograms per mililiters (mcg/mL)
Standard Deviation 29.254
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 8
|
—
|
42.33 micrograms per mililiters (mcg/mL)
Standard Deviation 20.880
|
81.25 micrograms per mililiters (mcg/mL)
Standard Deviation 41.734
|
80.72 micrograms per mililiters (mcg/mL)
Standard Deviation 40.377
|
76.88 micrograms per mililiters (mcg/mL)
Standard Deviation 32.047
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 12
|
—
|
46.90 micrograms per mililiters (mcg/mL)
Standard Deviation 19.759
|
81.17 micrograms per mililiters (mcg/mL)
Standard Deviation 42.878
|
83.89 micrograms per mililiters (mcg/mL)
Standard Deviation 21.875
|
74.06 micrograms per mililiters (mcg/mL)
Standard Deviation 32.283
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 16
|
0.00 micrograms per mililiters (mcg/mL)
Standard Deviation 0.000
|
51.26 micrograms per mililiters (mcg/mL)
Standard Deviation 19.349
|
80.56 micrograms per mililiters (mcg/mL)
Standard Deviation 46.644
|
83.35 micrograms per mililiters (mcg/mL)
Standard Deviation 43.518
|
77.95 micrograms per mililiters (mcg/mL)
Standard Deviation 47.186
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 20
|
86.49 micrograms per mililiters (mcg/mL)
Standard Deviation 43.182
|
50.91 micrograms per mililiters (mcg/mL)
Standard Deviation 20.004
|
79.51 micrograms per mililiters (mcg/mL)
Standard Deviation 50.180
|
82.14 micrograms per mililiters (mcg/mL)
Standard Deviation 21.151
|
38.73 micrograms per mililiters (mcg/mL)
Standard Deviation 19.023
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 24
|
90.40 micrograms per mililiters (mcg/mL)
Standard Deviation 51.619
|
55.55 micrograms per mililiters (mcg/mL)
Standard Deviation 24.609
|
65.57 micrograms per mililiters (mcg/mL)
Standard Deviation 31.614
|
45.13 micrograms per mililiters (mcg/mL)
Standard Deviation 31.291
|
23.93 micrograms per mililiters (mcg/mL)
Standard Deviation 17.506
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 28
|
99.41 micrograms per mililiters (mcg/mL)
Standard Deviation 58.863
|
58.31 micrograms per mililiters (mcg/mL)
Standard Deviation 24.150
|
62.20 micrograms per mililiters (mcg/mL)
Standard Deviation 30.876
|
68.88 micrograms per mililiters (mcg/mL)
Standard Deviation 13.172
|
2.02 micrograms per mililiters (mcg/mL)
Standard Deviation 1.742
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 32
|
30.13 micrograms per mililiters (mcg/mL)
Standard Deviation 23.807
|
48.68 micrograms per mililiters (mcg/mL)
Standard Deviation 21.937
|
12.95 micrograms per mililiters (mcg/mL)
Standard Deviation 18.318
|
56.96 micrograms per mililiters (mcg/mL)
Standard Deviation NA
NA indicates that standard deviation was not calculable because only one participant was involved in the analysis.
|
38.84 micrograms per mililiters (mcg/mL)
Standard Deviation NA
NA indicates that standard deviation was not calculable because only one participant was involved in the analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Bermekimab Concentration Over Time
Week 36
|
—
|
7.31 micrograms per mililiters (mcg/mL)
Standard Deviation 6.821
|
0.57 micrograms per mililiters (mcg/mL)
Standard Deviation 0.813
|
4.44 micrograms per mililiters (mcg/mL)
Standard Deviation NA
NA indicates that standard deviation was not calculable because only one participant was involved in the analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 36Population: The immunogenicity analysis set included all participants who had received at least 1 dose of bermekimab and who had at least 1 sample obtained after their first dose of bermekimab for the detection of antibodies to bermekimab.
Number of participants with anti-bermekimab antibodies were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg
n=33 Participants
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg
n=22 Participants
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Dupilumab
n=3 Participants
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Placebo Then Bermekimab 700 mg
n=5 Participants
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Bermekimab Antibodies
|
1 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Bermekimab 350 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Bermekimab 700 mg
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Dupilumab
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo Then Bermekimab 700 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Bermekimab 350 mg Then Bermekimab 350 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dupilumab Then Dupilumab 300 mg (Responders)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Dupilumab Then Bermekimab 700 mg (Non-Responders)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=33 participants at risk
Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.
|
Bermekimab 350 mg
n=33 participants at risk
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15.
|
Bermekimab 700 mg
n=67 participants at risk
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15.
|
Dupilumab
n=65 participants at risk
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14.
|
Placebo Then Bermekimab 700 mg
n=19 participants at risk
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg Then Bermekimab 350 mg
n=21 participants at risk
After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)
n=22 participants at risk
After completion of placebo-controlled period, at Week 16 participants who did not achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
n=3 participants at risk
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
n=5 participants at risk
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
n=27 participants at risk
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
n=11 participants at risk
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Auricular Haematoma
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Placebo
n=33 participants at risk
Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.
|
Bermekimab 350 mg
n=33 participants at risk
Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15.
|
Bermekimab 700 mg
n=67 participants at risk
Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15.
|
Dupilumab
n=65 participants at risk
Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14.
|
Placebo Then Bermekimab 700 mg
n=19 participants at risk
After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 350 mg Then Bermekimab 350 mg
n=21 participants at risk
After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)
n=22 participants at risk
After completion of placebo-controlled period, at Week 16 participants who did not achieved an eczema area and severity index (EASI-75) response (greater than or equal to \[\>=\] 75 percent \[%\] improvement from baseline) were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 700 mg (Responders)
n=3 participants at risk
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
|
Bermekimab 700 mg Then Bermekimab 350 mg (Responders)
n=5 participants at risk
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.
|
Dupilumab Then Dupilumab 300 mg (Responders)
n=27 participants at risk
After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.
|
Dupilumab Then Bermekimab 700 mg (Non-Responders)
n=11 participants at risk
After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Dry Eye
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.5%
1/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest Pain
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
6.1%
2/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
7.5%
5/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection Site Swelling
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.5%
3/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Covid-19
|
12.1%
4/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
6.1%
2/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.1%
2/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
26.3%
5/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
14.3%
3/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
13.6%
3/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
18.2%
2/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Eczema Impetiginous
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
2/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Impetigo
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Lice Infestation
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
3/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
11.9%
8/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.2%
6/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
13.6%
3/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
14.8%
4/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
18.2%
2/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Oral Herpes
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.1%
2/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.8%
1/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pilonidal Cyst
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
3/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
6.0%
4/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
6.2%
4/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.8%
1/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.5%
1/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
11.1%
3/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood Pressure Increased
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.1%
2/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
2/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
7.5%
5/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
7.7%
5/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.5%
1/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.0%
1/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
5.3%
1/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.8%
1/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
6.1%
2/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.8%
1/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
12.1%
4/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
3/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
16.4%
11/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
6.2%
4/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
4.8%
1/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
18.2%
4/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
3.7%
1/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/33 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/67 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
1.5%
1/65 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/19 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/21 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/22 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
0.00%
0/27 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
9.1%
1/11 • From Day 1 up to Week 36 for serious and other (non-serious) adverse events; all-cause mortality: from screening up to end of study (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of study intervention.
|
Additional Information
Director Clinical Research Dermatology
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER