Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa (NCT NCT04019041)
NCT ID: NCT04019041
Last Updated: 2023-07-27
Results Overview
HiSCR was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Week 12
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Placebo (Week 0-16)
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
Bermekimab 400 mg q2w (Week 0-16)
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo to Bermekimab 400 mg qw (Week 17-36)
At Week 16, participants who received placebo during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up (F-u) at Week 32 through Week 36.
|
Bermekimab 400 mg q2w (Week 17-36)
At Week 16, participants who received bermekimab 400 mg q2w during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection q2w with matching placebo through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
Bermekimab 400 mg qw (Week 17-36)
At Week 16, participants who received bermekimab 400 mg qw during placebo-controlled period entered into active treatment period and continued to receive bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
|---|---|---|---|---|---|---|
|
Placebo Controlled Period (Weeks 0-16)
STARTED
|
52
|
50
|
51
|
0
|
0
|
0
|
|
Placebo Controlled Period (Weeks 0-16)
COMPLETED
|
48
|
43
|
43
|
0
|
0
|
0
|
|
Placebo Controlled Period (Weeks 0-16)
NOT COMPLETED
|
4
|
7
|
8
|
0
|
0
|
0
|
|
Active Treatment+Safety F-U (Week 17-36)
STARTED
|
0
|
0
|
0
|
48
|
43
|
43
|
|
Active Treatment+Safety F-U (Week 17-36)
COMPLETED
|
0
|
0
|
0
|
42
|
35
|
38
|
|
Active Treatment+Safety F-U (Week 17-36)
NOT COMPLETED
|
0
|
0
|
0
|
6
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo (Week 0-16)
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
Bermekimab 400 mg q2w (Week 0-16)
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo to Bermekimab 400 mg qw (Week 17-36)
At Week 16, participants who received placebo during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up (F-u) at Week 32 through Week 36.
|
Bermekimab 400 mg q2w (Week 17-36)
At Week 16, participants who received bermekimab 400 mg q2w during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection q2w with matching placebo through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
Bermekimab 400 mg qw (Week 17-36)
At Week 16, participants who received bermekimab 400 mg qw during placebo-controlled period entered into active treatment period and continued to receive bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
|---|---|---|---|---|---|---|
|
Placebo Controlled Period (Weeks 0-16)
Withdrawal by Subject
|
3
|
5
|
4
|
0
|
0
|
0
|
|
Placebo Controlled Period (Weeks 0-16)
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Placebo Controlled Period (Weeks 0-16)
Other
|
1
|
2
|
1
|
0
|
0
|
0
|
|
Placebo Controlled Period (Weeks 0-16)
Imprisonment/compulsory detention
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Active Treatment+Safety F-U (Week 17-36)
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
2
|
1
|
|
Active Treatment+Safety F-U (Week 17-36)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Active Treatment+Safety F-U (Week 17-36)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Active Treatment+Safety F-U (Week 17-36)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
3
|
|
Active Treatment+Safety F-U (Week 17-36)
Other
|
0
|
0
|
0
|
0
|
3
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 13.85 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 14.02 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 13.81 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
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/Ethnicity, Customized
White
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
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/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The full analysis set (FAS) included all randomized participants who received at least 1 dose of study agent.
HiSCR was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
|
44.0 Percentage of participants
|
54.9 Percentage of participants
|
46.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
Change from baseline in NRS for pain and itch at Weeks 12 and 16 was reported. Participants were given a take-home diary to complete each night before bed. Participants were asked to report "average pain", and "worst moment pain" as well as "average itch" and "worst moment itch" on a 0 to 10 NRS, where 0=no itch or no pain and 10=worst itch or worst pain. Higher score indicated more severity.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=44 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=41 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=41 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pain & Itch at Weeks 12 and 16
Pain: Week 12
|
-1.92 scores on a scale
Standard Deviation 2.528
|
-1.67 scores on a scale
Standard Deviation 2.472
|
-1.47 scores on a scale
Standard Deviation 1.987
|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pain & Itch at Weeks 12 and 16
Pain: Week 16
|
-1.80 scores on a scale
Standard Deviation 2.537
|
-1.63 scores on a scale
Standard Deviation 2.307
|
-1.52 scores on a scale
Standard Deviation 2.086
|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pain & Itch at Weeks 12 and 16
Itch: Week 12
|
-1.82 scores on a scale
Standard Deviation 2.767
|
-1.62 scores on a scale
Standard Deviation 2.764
|
-1.79 scores on a scale
Standard Deviation 2.356
|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pain & Itch at Weeks 12 and 16
Itch: Week 16
|
-1.29 scores on a scale
Standard Deviation 2.940
|
-1.45 scores on a scale
Standard Deviation 2.660
|
-1.66 scores on a scale
Standard Deviation 3.081
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
Change form baseline in total AN count at Weeks 12 and 16 was reported. Abscess and inflammatory nodule were counted for the hidradenitis suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=46 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=47 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=49 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change Form Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Weeks 12 and 16
Week 12
|
-4.0 Abscess and inflammatory nodule
Standard Deviation 6.97
|
-5.2 Abscess and inflammatory nodule
Standard Deviation 6.18
|
-3.7 Abscess and inflammatory nodule
Standard Deviation 7.95
|
|
Change Form Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Weeks 12 and 16
Week 16
|
-4.8 Abscess and inflammatory nodule
Standard Deviation 8.31
|
-5.1 Abscess and inflammatory nodule
Standard Deviation 6.54
|
-5.1 Abscess and inflammatory nodule
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
Change form baseline in number of draining fistulas at Weeks 12 and 16 was reported. Draining fistula were defined as fistulas that drain serious or purulent fluid, either spontaneously or by gentle palpation.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=46 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=47 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=49 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Number of Draining Fistulas at Weeks 12 and 16
Week 12
|
0.1 fistulas
Standard Deviation 4.54
|
-0.3 fistulas
Standard Deviation 0.82
|
-0.6 fistulas
Standard Deviation 1.90
|
|
Change From Baseline in Number of Draining Fistulas at Weeks 12 and 16
Week 16
|
-0.5 fistulas
Standard Deviation 1.17
|
-0.3 fistulas
Standard Deviation 1.76
|
-0.6 fistulas
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent.
HiSCR was defined as at least 50% reduction in AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
|
52.0 percentage of participants
|
56.9 percentage of participants
|
44.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
Change from baseline in mHSS at Weeks 12 and 16 was reported. The sartorius scale was used to quantify the severity of HS. Points were awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between 2 lesions (2-6 points, 0 if no lesions); and if lesions were separated by normal skin (yes: 0 points; no: 6 points). The total sartorius score was the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=46 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=47 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=49 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Modified Hidradenitis Suppurativa Score (mHSS) at Weeks 12 and 16
Week 12
|
-13.2 scores on a scale
Standard Deviation 42.54
|
-26.1 scores on a scale
Standard Deviation 20.94
|
-24.0 scores on a scale
Standard Deviation 35.36
|
|
Change From Baseline in Modified Hidradenitis Suppurativa Score (mHSS) at Weeks 12 and 16
Week 16
|
-22.4 scores on a scale
Standard Deviation 44.53
|
-24.1 scores on a scale
Standard Deviation 30.47
|
-26.8 scores on a scale
Standard Deviation 43.19
|
SECONDARY outcome
Timeframe: Weeks 12 and 16Population: The FAS included all randomized participants who received at least 1 dose of study agent.
HS-PGA was physician assessment of severity of disease based on 6-point scale:Clear (0)=total number of abscesses, inflammatory nodule, non-inflammatory nodule and draining fistulas was 0;Minimal (1)=total number of abscesses,draining fistulas, inflammatory nodule was 0, presence of non-inflammatory nodule;Mild (2)=total number of abscesses, draining fistulas was 0, total number of inflammatory nodule was 1-4, or presence of 1 abscess or draining fistula and absence of any inflammatory nodules;Moderate (3)=total number of abscesses and draining fistulas was 0, total number of inflammatory nodule was at least 5; or presence of 1 abscess or draining fistula and at least 1 inflammatory nodule; or 2-5 abscesses or draining fistulas, fewer than 10 inflammatory nodule;Severe (4)=total number of abscesses or draining fistulas was 2-5, total number of inflammatory nodule was at least 10;Very severe (5)=more than 5 abscesses or draining fistulas.Higher score indicated more severity of disease.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved HS-PGA of Clear (0) or Minimal (1) or HS-PGA Score of Mild or Better (<=2) With at Least a 2-grade Improvement Relative to Baseline at Weeks 12 and 16
Week 12
|
2.0 percentage of participants
|
17.6 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants Who Achieved HS-PGA of Clear (0) or Minimal (1) or HS-PGA Score of Mild or Better (<=2) With at Least a 2-grade Improvement Relative to Baseline at Weeks 12 and 16
Week 16
|
2.0 percentage of participants
|
19.6 percentage of participants
|
11.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
The HADS was an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes in a participant's emotional state. It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale was obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (\>) 9 = anxiety; HADS (depression): 0-8 = no depression; \>9 = depression.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12 and 16
HADS anxiety: Week 12
|
-1.4 scores on a scale
Standard Deviation 3.54
|
-1.5 scores on a scale
Standard Deviation 3.65
|
-1.7 scores on a scale
Standard Deviation 2.70
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12 and 16
HADS anxiety: Week 16
|
-1.8 scores on a scale
Standard Deviation 3.17
|
-1.8 scores on a scale
Standard Deviation 3.13
|
-1.6 scores on a scale
Standard Deviation 3.19
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12 and 16
HADS depression: Week 12
|
-0.8 scores on a scale
Standard Deviation 2.41
|
-1.5 scores on a scale
Standard Deviation 3.48
|
-0.6 scores on a scale
Standard Deviation 2.58
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12 and 16
HADS depression: Week 16
|
-0.9 scores on a scale
Standard Deviation 2.53
|
-1.3 scores on a scale
Standard Deviation 3.15
|
-0.5 scores on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
DLQI was a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The DLQI domains include symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The participant respond on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (that is, negative change score) indicated improvement in the Quality of Life.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 16
Week 12
|
-4.5 scores on a scale
Standard Deviation 7.09
|
-4.6 scores on a scale
Standard Deviation 5.07
|
-3.8 scores on a scale
Standard Deviation 4.91
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 16
Week 16
|
-5.1 scores on a scale
Standard Deviation 7.09
|
-4.7 scores on a scale
Standard Deviation 5.27
|
-4.2 scores on a scale
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
The EQ-5D-3L was a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D-3L-VAS records the participant's self-rated health on a vertical VAS that allows the participants to indicate their health state that can range from 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Health Status as Assessed by EuroQol-5 Dimension Instrument-3 Levels (EQ-5D-3L) Visual Analogue Scale (VAS) Scores at Weeks 12 and 16
Week 12
|
6.9 scores on a scale
Standard Deviation 14.69
|
3.7 scores on a scale
Standard Deviation 19.20
|
7.2 scores on a scale
Standard Deviation 14.30
|
|
Change From Baseline in Health Status as Assessed by EuroQol-5 Dimension Instrument-3 Levels (EQ-5D-3L) Visual Analogue Scale (VAS) Scores at Weeks 12 and 16
Week 16
|
7.7 scores on a scale
Standard Deviation 14.60
|
6.1 scores on a scale
Standard Deviation 17.47
|
9.3 scores on a scale
Standard Deviation 14.23
|
SECONDARY outcome
Timeframe: Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
The PGI-c was a single-item patient reported outcome (PRO) that assessed change in severity of skin pain due to HS. Participants rated how his/her HS had changed since the beginning of the study using a 7-point scale ranging from 1 to 7 where 1 indicates "very much better", 2 indicates "Much better', 3 indicates "A little better", 4 indicates "No change", 5 indicates "A little worse", 6 indicates "Much worse" and 7 indicates "Very much worse".
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=42 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=44 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=48 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Very much better: Week 12
|
1 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Much better: Week 12
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
A little better: Week 12
|
14 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
No change: Week 12
|
14 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
A little worse: Week 12
|
6 Participants
|
8 Participants
|
13 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Much worse: Week 12
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Very much worse: Week 12
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Very much better: Week 16
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Much better: Week 16
|
6 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
A little better: Week 16
|
8 Participants
|
12 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
No change: Week 16
|
17 Participants
|
12 Participants
|
13 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
A little worse: Week 16
|
6 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Much worse: Week 16
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Patient Global Impression of Change (PGI-c) at Week 12 and 16
Very much worse: Week 16
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
The PGI-s was a single-item PRO that assessed change in a participant's impression of their disease severity. The PGI-s item asks the respondent to best describe how his/her HS symptoms are now (that is, "check the one number that best describes how your HS symptoms are now") on a 4-point scale scored as: "normal" (1), "mild" (2), "moderate" (3), or "severe" (4)".
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=42 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=44 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=48 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Severe: Week 12
|
0 Participants
|
4 Participants
|
12 Participants
|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Normal: Week 16
|
3 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Severe: Week 16
|
2 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Normal: Week 12
|
3 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Mild: Week 12
|
19 Participants
|
19 Participants
|
12 Participants
|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Moderate: Week 12
|
19 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Mild: Week 16
|
22 Participants
|
16 Participants
|
18 Participants
|
|
Number of Participants With Patient Global Impression of Severity (PGI-s) at Weeks 12 and 16
Moderate: Week 16
|
15 Participants
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours with a score range from 0 (no symptom experience) to 10 (worst possible symptom experience). A total symptom score also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period. Change from baseline in HS-related pain symptom score in the past 24 hours based on HSSD was reported.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=51 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Weeks 12 and 16
Week 12
|
-1.8 scores on a scale
Standard Deviation 3.05
|
-1.9 scores on a scale
Standard Deviation 2.81
|
-1.7 scores on a scale
Standard Deviation 2.81
|
|
Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Weeks 12 and 16
Week 16
|
-1.9 scores on a scale
Standard Deviation 2.97
|
-1.9 scores on a scale
Standard Deviation 2.85
|
-1.9 scores on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 16Population: The FAS included all randomized participants who received at least 1 dose of study agent. Here, 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
The HSSD was a 7-item patient self-reported questionnaire that assessed 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms had a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. Each individual symptom scale score, ranging from 0-10, was summarized. A total symptom score, which also ranged from 0-10, was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 Participants
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=52 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Change From Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD) Total Symptom Score at Weeks 12 and 16
Week 12
|
-2.1 scores on a scale
Standard Deviation 2.38
|
-2.1 scores on a scale
Standard Deviation 2.19
|
-1.9 scores on a scale
Standard Deviation 2.16
|
|
Change From Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD) Total Symptom Score at Weeks 12 and 16
Week 16
|
-2.0 scores on a scale
Standard Deviation 2.33
|
-1.9 scores on a scale
Standard Deviation 2.29
|
-1.8 scores on a scale
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 5, 8, 12, and 16Population: The pharmacokinetic (PK) analysis set included all participants who received at least 1 complete dose of bermekimab and had at least 1 valid blood sample drawn for PK analysis after their first dose of bermekimab. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
Serum concentration of bermekimab was reported. This outcome measure was planned to be analyzed for specified arms only.
Outcome measures
| Measure |
Bermekimab 400 mg q2w (Week 0-16)
n=50 Participants
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo (Week 0-16)
n=50 Participants
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
|---|---|---|---|
|
Serum Concentration of Bermekimab
Week 0
|
0.00 micrograms per milliliter (mcg/mL)
Standard Deviation 0.000
|
—
|
0.00 micrograms per milliliter (mcg/mL)
Standard Deviation 0.000
|
|
Serum Concentration of Bermekimab
Week 1
|
35.76 micrograms per milliliter (mcg/mL)
Standard Deviation 19.153
|
—
|
31.60 micrograms per milliliter (mcg/mL)
Standard Deviation 18.697
|
|
Serum Concentration of Bermekimab
Week 2
|
48.81 micrograms per milliliter (mcg/mL)
Standard Deviation 25.938
|
—
|
37.75 micrograms per milliliter (mcg/mL)
Standard Deviation 20.620
|
|
Serum Concentration of Bermekimab
Week 3
|
38.09 micrograms per milliliter (mcg/mL)
Standard Deviation 25.627
|
—
|
16.44 micrograms per milliliter (mcg/mL)
Standard Deviation 12.725
|
|
Serum Concentration of Bermekimab
Week 4
|
34.71 micrograms per milliliter (mcg/mL)
Standard Deviation 21.042
|
—
|
20.22 micrograms per milliliter (mcg/mL)
Standard Deviation 14.118
|
|
Serum Concentration of Bermekimab
Week 5
|
30.95 micrograms per milliliter (mcg/mL)
Standard Deviation 20.248
|
—
|
9.94 micrograms per milliliter (mcg/mL)
Standard Deviation 9.794
|
|
Serum Concentration of Bermekimab
Week 8
|
28.34 micrograms per milliliter (mcg/mL)
Standard Deviation 17.659
|
—
|
21.43 micrograms per milliliter (mcg/mL)
Standard Deviation 15.529
|
|
Serum Concentration of Bermekimab
Week 12
|
29.36 micrograms per milliliter (mcg/mL)
Standard Deviation 16.891
|
—
|
20.87 micrograms per milliliter (mcg/mL)
Standard Deviation 13.407
|
|
Serum Concentration of Bermekimab
Week 16
|
31.03 micrograms per milliliter (mcg/mL)
Standard Deviation 18.503
|
—
|
21.35 micrograms per milliliter (mcg/mL)
Standard Deviation 17.958
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 12 and 16Population: Due to change in planned analysis, data was not collected for this outcome measure hence analysis was not performed.
Reduction from baseline in serum IL-6 was reported.
Outcome measures
Outcome data not reported
Adverse Events
Placebo (Week 0-16)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Bermekimab 400 mg q2w (Week 0-16)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Bermekimab 400 mg qw (Week 0-16)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo to Bermekimab 400 mg qw (Week 17-36)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Bermekimab 400 mg q2w (Week 17-36)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Bermekimab 400 mg qw (Week 17-36)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Week 0-16)
n=52 participants at risk
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
Bermekimab 400 mg q2w (Week 0-16)
n=50 participants at risk
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 participants at risk
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo to Bermekimab 400 mg qw (Week 17-36)
n=48 participants at risk
At Week 16, participants who received placebo during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up (F-u) at Week 32 through Week 36.
|
Bermekimab 400 mg q2w (Week 17-36)
n=43 participants at risk
At Week 16, participants who received bermekimab 400 mg q2w during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection q2w with matching placebo through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
Bermekimab 400 mg qw (Week 17-36)
n=43 participants at risk
At Week 16, participants who received bermekimab 400 mg qw during placebo-controlled period entered into active treatment period and continued to receive bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus Tachycardia
|
1.9%
1/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Infections and infestations
Covid-19
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Infections and infestations
Influenza
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.0%
1/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Nervous system disorders
Epilepsy
|
1.9%
1/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
Other adverse events
| Measure |
Placebo (Week 0-16)
n=52 participants at risk
Participants received placebo as subcutaneous (SC) injection at Weeks 0 and 1, and once every week (qw) from Week 2 through Week 16.
|
Bermekimab 400 mg q2w (Week 0-16)
n=50 participants at risk
Participants received loading dose of bermekimab 800 milligrams (mg) (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg once every 2 weeks (q2w) alternating with matching placebo q2w through Week 16.
|
Bermekimab 400 mg qw (Week 0-16)
n=51 participants at risk
Participants received loading dose of bermekimab 800 mg (2\*400 mg) as SC injection at Weeks 0 and 1, followed by bermekimab 400 mg qw through Week 16.
|
Placebo to Bermekimab 400 mg qw (Week 17-36)
n=48 participants at risk
At Week 16, participants who received placebo during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up (F-u) at Week 32 through Week 36.
|
Bermekimab 400 mg q2w (Week 17-36)
n=43 participants at risk
At Week 16, participants who received bermekimab 400 mg q2w during placebo-controlled period entered into active treatment period and received bermekimab 400 mg as SC injection q2w with matching placebo through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
Bermekimab 400 mg qw (Week 17-36)
n=43 participants at risk
At Week 16, participants who received bermekimab 400 mg qw during placebo-controlled period entered into active treatment period and continued to receive bermekimab 400 mg as SC injection qw through Week 31. All participants entered safety follow-up at Week 32 through Week 36.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
6.0%
3/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
4.0%
2/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
7.8%
4/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
6.2%
3/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
General disorders
Injection Site Swelling
|
0.00%
0/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
4.0%
2/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.0%
1/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
6.2%
3/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
6.0%
3/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
3.9%
2/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.9%
1/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.0%
1/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
5.9%
3/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Infections and infestations
Urinary Tract Infection
|
7.7%
4/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.0%
1/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.1%
1/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
3/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Nervous system disorders
Headache
|
3.8%
2/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
6.0%
3/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
3.9%
2/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
4.2%
2/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
2.3%
1/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
7.7%
4/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
0.00%
0/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
5.8%
3/52 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
4.0%
2/50 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
9.8%
5/51 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
8.3%
4/48 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
4.7%
2/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
4.7%
2/43 • Placebo Controlled Period: Weeks 0 to 16; Active Treatment + Safety Follow-up Period: Weeks 17 to 36
The safety analysis set included all randomized participants who received at least 1 dose of study agent, that is, the treated population.
|
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 with hold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER