Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis (NCT NCT04021862)
NCT ID: NCT04021862
Last Updated: 2025-02-04
Results Overview
Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response was 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 severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. This outcome measure was planned to be analyzed for specified arms only.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Week 16
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Placebo (Week 0 - 16)
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Placebo Controlled Period (Week 0-16)
STARTED
|
29
|
29
|
29
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-16)
COMPLETED
|
27
|
28
|
27
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-16)
NOT COMPLETED
|
2
|
1
|
2
|
0
|
0
|
0
|
|
Active Treatment Period (Week 16-32)
STARTED
|
0
|
0
|
0
|
27
|
28
|
27
|
|
Active Treatment Period (Week 16-32)
COMPLETED
|
0
|
0
|
0
|
26
|
28
|
27
|
|
Active Treatment Period (Week 16-32)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo (Week 0 - 16)
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Placebo Controlled Period (Week 0-16)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-16)
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-16)
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Placebo Controlled Period (Week 0-16)
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Active Treatment Period (Week 16-32)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 15.59 • n=5 Participants
|
44 years
STANDARD_DEVIATION 15.71 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 16.65 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 16.25 • n=4 Participants
|
|
Age, Customized
Adults (18-64 years)
|
23 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Age, Customized
From 65 to 84 years
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Age, Customized
85 years and over
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study agent.
Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response was 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 severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) Response at Week 16
|
13.8 percentage of participants
|
24.1 percentage of participants
|
34.5 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16 and 32Population: FAS included all randomized participants who received at least 1 dose of study agent. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Percentage of participants achieving greater than or equal to (\>=4) point improvement (reduction from baseline) in weekly average peak (worst) daily pruritus NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related itch participants were asked the following question: please rate the severity of your eczema-related itch at its worst in the past 24 hours. The response was rated on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible". Higher score indicated more severity. Seven daily average NRS scores are into a weekly score.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=26 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=25 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=23 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=25 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=25 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=23 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4
Week 4
|
26.9 percentage of participants
|
8.0 percentage of participants
|
8.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4
Week 8
|
34.6 percentage of participants
|
16.0 percentage of participants
|
26.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4
Week 12
|
46.2 percentage of participants
|
28.0 percentage of participants
|
30.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4
Week 16
|
53.8 percentage of participants
|
32.0 percentage of participants
|
52.2 percentage of participants
|
56.0 percentage of participants
|
32.0 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants Achieving >=4 Point Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Pruritus (Itch) Numeric Rating Scale (NRS) Score From Baseline at Week 4, 8, 12, 16 and 32 Among Participants With Baseline Score >=4
Week 32
|
—
|
—
|
—
|
80.0 percentage of participants
|
64.0 percentage of participants
|
65.2 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16 and 32Population: FAS included all randomized participants who received at least 1 dose of study agent. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Percentage of participants achieving \>= 4 improvement (reduction from baseline) in weekly average of average daily pruritis NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related itch participants were asked the following question: please rate the severity of your eczema-related average itch in the past 24 hours. The response was rated on a 0 to 10 NRS. Higher score indicated more severity. Seven daily averaged NRS scores were averaged into a weekly score.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=26 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=22 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=22 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=14 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=12 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=17 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 4
|
23.1 percentage of participants
|
13.6 percentage of participants
|
9.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 8
|
30.8 percentage of participants
|
22.7 percentage of participants
|
27.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 12
|
50.0 percentage of participants
|
27.3 percentage of participants
|
40.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 16
|
50.0 percentage of participants
|
50.0 percentage of participants
|
54.5 percentage of participants
|
35.7 percentage of participants
|
25.0 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving >= 4 Point Improvement (Reduction From Baseline) in Weekly Average of Average Daily Pruritis (Itch) NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 32
|
—
|
—
|
—
|
71.4 percentage of participants
|
66.7 percentage of participants
|
58.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16 and 32Population: FAS included all randomized participants who received at least 1 dose of study agent. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Percentage of participants achieving \>=4 improvement (reduction from baseline) in weekly average peak (worst) daily skin pain NRS score from baseline at Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related skin pain participants were asked the following question: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours. The response was rated on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible". Seven daily NRS scores were averaged into a weekly score. Higher score indicated more severity.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=17 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=17 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=20 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=16 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=17 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=20 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 4
|
47.1 percentage of participants
|
23.5 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 8
|
41.2 percentage of participants
|
29.4 percentage of participants
|
30.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 12
|
41.2 percentage of participants
|
17.6 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 16
|
35.3 percentage of participants
|
29.4 percentage of participants
|
40.0 percentage of participants
|
37.5 percentage of participants
|
29.4 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average Peak (Worst) Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 32
|
—
|
—
|
—
|
56.3 percentage of participants
|
52.9 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16 and 32Population: FAS included all randomized participants who received at least 1 dose of study agent. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Percentage of participants achieving \>=4 improvement (reduction from baseline) in weekly average of average daily skin pain NRS score from baseline to Weeks 4, 8, 12, 16 and 32 among participants with a baseline score \>=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. To rate the severity of eczema-related skin pain participants were asked the following question: Please rate the severity of your eczema-related average skin pain in the past 24 hours; The response was rated on a 0 to 10 NRS. Higher score indicated more severity. Seven daily averaged NRS scores were averaged into a weekly score.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=15 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=12 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=17 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=14 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=12 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=17 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 4
|
40.0 percentage of participants
|
33.3 percentage of participants
|
17.6 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 8
|
33.3 percentage of participants
|
50.0 percentage of participants
|
35.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 12
|
40.0 percentage of participants
|
33.3 percentage of participants
|
52.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 16
|
33.3 percentage of participants
|
25.0 percentage of participants
|
47.1 percentage of participants
|
35.7 percentage of participants
|
25.0 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving >=4 Improvement (Reduction From Baseline) in Weekly Average of Average Daily Skin Pain NRS Score From Baseline at Weeks 4, 8, 12, 16 and 32 Among Participants With a Baseline Score >=4
Week 32
|
—
|
—
|
—
|
71.4 percentage of participants
|
66.7 percentage of participants
|
58.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 32Population: FAS included all randomized participants who received at least 1 dose of study agent. Here, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
Percentage of participants achieving EASI-75 response at Weeks 4, 8, 12, and 32 were reported. EASI-75 response was defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=28 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32
Week 4
|
10.3 percentage of participants
|
17.2 percentage of participants
|
10.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32
Week 8
|
10.3 percentage of participants
|
13.8 percentage of participants
|
17.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32
Week 12
|
13.8 percentage of participants
|
20.7 percentage of participants
|
37.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving EASI-75 Response at Weeks 4, 8, 12, and 32
Week 32
|
—
|
—
|
—
|
77.8 percentage of participants
|
69.0 percentage of participants
|
65.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS included all randomized participants who received at least 1 dose of study agent.
Percentage of participants with both IGA score of 0 or 1 and a reduction from baseline of \>=2 points was reported. IGA assesses AD severity and clinical response using a 5-point scale: 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, 4 = severe. A higher score indicated more severity of AD. The score was determined by ranking the extent of erythema and population/infiltration. A clinical response to therapy was an IGA score of 0 (clear) or 1 (almost clear). This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
IGA score of clear (0)
|
0 percentage of participants
|
6.9 percentage of participants
|
6.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
IGA score of clear (0) or almost clear (1)
|
6.9 percentage of participants
|
17.2 percentage of participants
|
13.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16
IGA score of mild or better (reduction from baseline of >=2 points)
|
24.1 percentage of participants
|
34.5 percentage of participants
|
34.5 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 16, and 32Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.
Percentage of participants achieving EASI-90 response at Weeks 12, 16 and 32 were reported. EASI-90 response was 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 severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The total EASI score is the sum of four body-region scores ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32
Week 12
|
6.9 percentage of participants
|
6.9 percentage of participants
|
10.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32
Week 16
|
0 percentage of participants
|
10.3 percentage of participants
|
10.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving EASI-90 Response at Weeks 12, 16, and 32
Week 32
|
—
|
—
|
—
|
37.0 percentage of participants
|
24.1 percentage of participants
|
34.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 12, 16 and 32Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. A higher score indicates more severe disease and poor QoL.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32
Week 16
|
-6.07 score on a scale
Standard Deviation 7.151
|
-3.38 score on a scale
Standard Deviation 3.886
|
-5.93 score on a scale
Standard Deviation 5.120
|
-6.52 score on a scale
Standard Deviation 7.213
|
—
|
—
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32
Week 32
|
—
|
—
|
—
|
-9.15 score on a scale
Standard Deviation 6.413
|
-4.10 score on a scale
Standard Deviation 5.759
|
-7.76 score on a scale
Standard Deviation 6.122
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32
Week 8
|
-4.86 score on a scale
Standard Deviation 5.598
|
-3.03 score on a scale
Standard Deviation 4.136
|
-3.41 score on a scale
Standard Deviation 4.694
|
—
|
—
|
—
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 8, 12, 16, and 32
Week 12
|
-4.86 score on a scale
Standard Deviation 5.774
|
-3.29 score on a scale
Standard Deviation 3.505
|
-4.72 score on a scale
Standard Deviation 5.028
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8,12,16 and 32Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.
In this outcome measure, change from baseline in HADS-Anxiety score at weeks 8, 12, 16 and 32 were reported. The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a participant's emotional state. The HADS is a 14-item self-administered questionnaire, 7 each for anxiety and depression symptoms. Each item is scored from 0-3, resulting in total anxiety score ranging from 0 (less severity of anxiety) to 21 (greater severity of anxiety). Higher score indicated more anxiety symptoms. The following cut-off scores are recommended: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32
Week 8
|
1.59 score on a scale
Standard Deviation 2.732
|
2.00 score on a scale
Standard Deviation 3.770
|
1.90 score on a scale
Standard Deviation 2.257
|
—
|
—
|
—
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32
Week 12
|
1.45 score on a scale
Standard Deviation 2.898
|
1.89 score on a scale
Standard Deviation 3.755
|
2.62 score on a scale
Standard Deviation 2.846
|
—
|
—
|
—
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32
Week 16
|
1.59 score on a scale
Standard Deviation 2.771
|
1.97 score on a scale
Standard Deviation 3.669
|
2.66 score on a scale
Standard Deviation 3.062
|
1.70 score on a scale
Standard Deviation 2.839
|
—
|
—
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) (Anxiety) Score at Weeks 8, 12, 16, and 32
Week 32
|
—
|
—
|
—
|
2.93 score on a scale
Standard Deviation 3.419
|
2.34 score on a scale
Standard Deviation 3.467
|
3.14 score on a scale
Standard Deviation 3.114
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8,12,16 and 32Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.
In this outcome measure, change from baseline in HADS-depression score at weeks 8, 12, 16 and 32 were reported. The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a participant's emotional state. The HADS is a 14-item self-administered questionnaire, and consists of 7 items each for anxiety and depression symptoms. Each item is scored from 0-3, resulting in total depression score ranging from 0 (less severity of depression) to 21 (greater severity of depression). Higher score indicated more depression symptoms. The following cut-off scores are recommended: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe depression.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32
Week 12
|
0.97 score on a scale
Standard Deviation 2.291
|
0.57 score on a scale
Standard Deviation 3.132
|
0.90 score on a scale
Standard Deviation 3.426
|
—
|
—
|
—
|
|
Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32
Week 16
|
0.93 score on a scale
Standard Deviation 2.103
|
0.31 score on a scale
Standard Deviation 2.989
|
1.07 score on a scale
Standard Deviation 3.139
|
1.00 score on a scale
Standard Deviation 2.166
|
—
|
—
|
|
Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32
Week 32
|
—
|
—
|
—
|
1.93 score on a scale
Standard Deviation 2.235
|
0.28 score on a scale
Standard Deviation 3.401
|
1.55 score on a scale
Standard Deviation 4.188
|
|
Change From Baseline in HADS (Depression) Score at Weeks 8, 12, 16, and 32
Week 8
|
0.86 score on a scale
Standard Deviation 1.941
|
0.59 score on a scale
Standard Deviation 3.088
|
1.31 score on a scale
Standard Deviation 2.904
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 12, 16, and 32Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). Higher scores indicated more severe disease and poor quality of life.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32
Week 16
|
-5.76 score on a scale
Standard Deviation 5.680
|
-6.00 score on a scale
Standard Deviation 5.542
|
-8.07 score on a scale
Standard Deviation 5.618
|
-6.19 score on a scale
Standard Deviation 5.657
|
—
|
—
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32
Week 8
|
-4.79 score on a scale
Standard Deviation 3.949
|
-5.66 score on a scale
Standard Deviation 5.627
|
-6.59 score on a scale
Standard Deviation 4.939
|
—
|
—
|
—
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32
Week 12
|
-5.07 score on a scale
Standard Deviation 5.021
|
-6.14 score on a scale
Standard Deviation 5.543
|
-7.55 score on a scale
Standard Deviation 4.903
|
—
|
—
|
—
|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Scores at Weeks 8, 12, 16, and 32
Week 32
|
—
|
—
|
—
|
-10.48 score on a scale
Standard Deviation 6.659
|
-8.66 score on a scale
Standard Deviation 6.726
|
-10.66 score on a scale
Standard Deviation 6.800
|
SECONDARY outcome
Timeframe: Baseline to Weeks 8, 12, 16 and 32Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.
SCORAD is a validated scoring index for AD, which consists of 3 components that is A =extent or affected body surface area assessed as percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on visual analogue scale, where "0" is no itch (or no sleeplessness) and "10" is worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7\*B/2+ C to give the SCORAD total score range of 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.
Week 8
|
21.53 score on a scale
Standard Deviation 11.468
|
21.29 score on a scale
Standard Deviation 15.632
|
19.39 score on a scale
Standard Deviation 11.632
|
—
|
—
|
—
|
|
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.
Week 12
|
24.27 score on a scale
Standard Deviation 13.130
|
26.50 score on a scale
Standard Deviation 12.894
|
22.45 score on a scale
Standard Deviation 12.849
|
—
|
—
|
—
|
|
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.
Week 16
|
25.90 score on a scale
Standard Deviation 15.916
|
27.56 score on a scale
Standard Deviation 13.661
|
24.11 score on a scale
Standard Deviation 14.961
|
27.82 score on a scale
Standard Deviation 14.743
|
—
|
—
|
|
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Weeks 8, 12, 16, and 32.
Week 32
|
—
|
—
|
—
|
44.35 score on a scale
Standard Deviation 16.479
|
31.92 score on a scale
Standard Deviation 18.467
|
35.05 score on a scale
Standard Deviation 18.461
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8,12,16 and 32Population: FAS; N (number of participants analyzed)=participants evaluated for this outcome measure, n (number analyzed)=participants analyzed at specified timepoints, 0=no participant analyzed. Week 16 data were collected and analyzed only for placebo crossover participants during active treatment period as pre-planned. For active treatment period assessments, participants who discontinued placebo controlled period in Bermekimab 400 mg q2w and Bermekimab 400 mg qw arms were also included as pre-planned.
GISS assesses AD lesions for erythema, excoriations, lichenification and edema/papulation. Each component was rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) according to the EASI grading severity. The cumulative score, which ranges from 0 to 12, is the sum of the four components. A higher score indicates more severe disease.
Outcome measures
| Measure |
Placebo (Week 0 - 16)
n=29 Participants
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 Participants
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 Participants
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 Participants
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=29 Participants
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.
Week 8
|
2.97 score on a scale
Standard Deviation 1.973
|
3.24 score on a scale
Standard Deviation 2.247
|
2.07 score on a scale
Standard Deviation 2.034
|
—
|
—
|
—
|
|
Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.
Week 12
|
3.48 score on a scale
Standard Deviation 2.385
|
3.54 score on a scale
Standard Deviation 2.516
|
2.93 score on a scale
Standard Deviation 2.313
|
—
|
—
|
—
|
|
Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.
Week 16
|
3.34 score on a scale
Standard Deviation 2.768
|
3.69 score on a scale
Standard Deviation 2.647
|
2.97 score on a scale
Standard Deviation 2.514
|
3.59 score on a scale
Standard Deviation 2.707
|
—
|
—
|
|
Change From Baseline in Global Individual Signs Score (GISS) at Weeks 8, 12, 16, and 32.
Week 32
|
—
|
—
|
—
|
5.70 score on a scale
Standard Deviation 2.799
|
3.97 score on a scale
Standard Deviation 2.934
|
3.97 score on a scale
Standard Deviation 2.860
|
Adverse Events
Placebo (Week 0 - 16)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bermekimab 400 mg q2w (Week 0 - 16)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Bermekimab 400 mg qw (Week 0 - 16)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bermekimab 400 mg q2w (Week 16 - 31)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bermekimab 400 mg qw (Week 16 - 31)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Week 0 - 16)
n=29 participants at risk
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 participants at risk
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 participants at risk
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 participants at risk
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=28 participants at risk
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=27 participants at risk
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.4%
1/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.4%
1/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
Other adverse events
| Measure |
Placebo (Week 0 - 16)
n=29 participants at risk
Participants received placebo matching to bermekimab (4 milliliters \[mL\]) subcutaneous (SC) injection at Week 0, followed by weekly (qw) placebo SC injections from Week 1 through Week 16.
|
Bermekimab 400 mg q2w (Week 0 - 16)
n=29 participants at risk
Participants received bermekimab 800 milligrams (mg) (400mg\*2) loading dose SC injection at Week 0 followed by bermekimab 400 mg SC injections every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0 - 16)
n=29 participants at risk
Participants received bermekimab 400 mg loading dose SC injection along with matching placebo loading dose SC injection at Week 0 followed by weekly (qw) SC injections of bermekimab 400 mg (2\*200 mg per mL) through Week 16.
|
Placebo Then Bermekimab 400 mg qw (Week 16 - 31)
n=27 participants at risk
After completion of placebo-controlled period, participants were crossed-over to active treatment period and received bermekimab 400 mg SC injection qw at Week 16 through Week 31.
|
Bermekimab 400 mg q2w (Week 16 - 31)
n=28 participants at risk
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection q2w alternating with matching placebo through Week 31.
|
Bermekimab 400 mg qw (Week 16 - 31)
n=27 participants at risk
After completion of placebo-controlled period, participants entered active treatment period and continued to receive bermekimab 400 mg SC injection qw through Week 31.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
6.9%
2/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
7.4%
2/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.7%
1/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
General disorders
Fatigue
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
6.9%
2/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
General disorders
Injection Site Swelling
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
6.9%
2/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.6%
1/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
Infections and infestations
Influenza
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
6.9%
2/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
2/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.4%
1/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
10.3%
3/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.7%
1/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.4%
1/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
10.7%
3/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
3.4%
1/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
6.9%
2/29 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/28 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
0.00%
0/27 • Up to Week 36
The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.
|
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 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