Hidradenitis Suppurativa
Conditions
Brief summary
The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).
Detailed description
Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects 1 percent (%) to 4% of the general population. JNJ-77474462 (bermekimab) is a recombinant human immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb) that binds with high affinity and selectivity for human interleukin-1 alpha (IL-1 alpha) and is an effective blocker of IL-1 alpha biological activity. IL-1 alpha is a key mediator of sterile inflammatory responses. Skin is a significant reservoir of preformed IL-1 alpha, and it has been postulated that IL-1 alpha may play a role in the pathophysiology of multiple inflammatory skin disorders, including HS. Part 1 of this study contains 4 study periods: up to 6 weeks screening period (Period 1), 16-week placebo-controlled period (Period 2), 16-week cross over period (Period 3), and 4-week safety follow-up (Period 4). Part 2 of this study also contains 4 study periods: up to 6 weeks screening period (Period 1), 12-week placebo-controlled period (Period 2), 20-week cross over period (Period 3), and 4-week safety follow up (Period 4). Safety will be assessed by adverse events (AEs), serious adverse event (SAEs), physical examinations, vital signs, electrocardiograms, clinical safety laboratory assessments, allergic reaction, injection-site reactions, and tuberculosis evaluations. The total duration of study participation will be up to 42 weeks.
Interventions
DRUGBermekimab
Bermekimab will be administered subcutaneously.
DRUGAdalimumab
Adalimumab will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have hidradenitis suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history * Have Hurley Stage II or Hurley Stage III HS as determined by the investigator at screening and baseline visits * Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold) at screening and baseline visits * Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (\>=) 5 at the screening and baseline visit * Agree not to receive a live virus or live bacterial vaccination during the study and for 90 days after the last administration of study intervention
Exclusion criteria
* Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * Has unstable cardiovascular disease, defined as a recent clinical deterioration (that is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months * Has or has had herpes zoster within the 2 months before screening * Has a transplanted organ (with exception of a corneal transplant greater than \[\>\] 3 months before the first administration of study intervention) * Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 | Week 16 | HiSCR50 was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16 | Week 16 | HiSCR90 was defined as at least 90% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. |
| Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16 | Baseline, Week 16 | Change from baseline in the AN count as Week 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. |
| Part 1: Change From Baseline in Number of Abscess at Week 16 | Baseline, Week 16 | Change from baseline in number of abscess at Week 16 was reported. |
| Part 1: Change From Baseline in Number of Draining Fistula at Week 16 | Baseline, Week 16 | Change from baseline in number of draining fistula at Week 16 was reported. Draining fistula was defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. |
| Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16 | Baseline, Week 16 | Change from baseline in number of inflammatory nodules at Week 16 was reported. Inflammatory nodules arise from inflamed blood vessels (vasculitis) or adipose tissue (panniculitis). |
| Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16 | Week 16 | HiSCR75 was defined as at least 75% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. |
| Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | Baseline, Week 16 | The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. The participant's HS was assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild activity (2) and with at least 2-grade improvement relative to baseline at Week 16 were reported. |
| Part 1: 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 Week 16 | Baseline, Week 16 | 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. |
| Serum Concentration of Bermekimab | Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 | Serum concentration of bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36. |
| Number of Participants With Antibodies to Bermekimab | From baseline up to Week 36 | Number of participants with antibodies to bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36. |
| Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16 | Baseline up to Week 16 | IHS4 was a dynamic severity assessment of HS. IHS4 score was arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Higher scores indicate more severity. |
Countries
Australia, Canada, Germany, Japan, Netherlands, Poland, Spain, United States
Participant flow
Pre-assignment details
As per change in planned analysis, Part 2 of this study was not conducted due to early termination because interim analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint. Hence, data for Part 2 and some secondary efficacy outcome measures (Parts 1 and 2) were not reported in this results summary.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Placebo (Week 0-16) Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1. | 50 |
| Part 1: Bermekimab (Week 0-36) Participants received bermekimab 1050 mg (3\*350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\*350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1. Participants who received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 36 in Part 1. | 51 |
| Part 1: Adalimumab (Week 0-16) Participants received adalimumab 160 mg (4\*40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\*40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1. | 50 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Active Treatment+Safety F-U (Week 17-36) | Lost to Follow-up | 0 | 0 | 0 | 3 | 3 | 1 |
| Active Treatment+Safety F-U (Week 17-36) | Other | 0 | 0 | 0 | 10 | 10 | 14 |
| Active Treatment+Safety F-U (Week 17-36) | Study terminated by sponsor | 0 | 0 | 0 | 5 | 6 | 2 |
| Active Treatment+Safety F-U (Week 17-36) | Withdrawal by Subject | 0 | 0 | 0 | 3 | 2 | 1 |
| Placebo Controlled Period (Weeks 0-16) | Death | 0 | 0 | 1 | 0 | 0 | 0 |
| Placebo Controlled Period (Weeks 0-16) | Lost to Follow-up | 4 | 4 | 0 | 0 | 0 | 0 |
| Placebo Controlled Period (Weeks 0-16) | Other | 10 | 9 | 14 | 0 | 0 | 0 |
| Placebo Controlled Period (Weeks 0-16) | Study terminated by sponsor | 6 | 4 | 3 | 0 | 0 | 0 |
| Placebo Controlled Period (Weeks 0-16) | Withdrawal by Subject | 2 | 4 | 4 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: Bermekimab (Week 0-36) | Part 1: Adalimumab (Week 0-16) | Part 1: Placebo (Week 0-16) | Total |
|---|---|---|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 9.67 | 35.7 years STANDARD_DEVIATION 12.2 | 38.1 years STANDARD_DEVIATION 12.55 | 36.8 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 41 Participants | 38 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 10 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 3 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) White | 37 Participants | 32 Participants | 32 Participants | 101 Participants |
| Region of Enrollment AUSTRALIA | 4 Participants | 4 Participants | 1 Participants | 9 Participants |
| Region of Enrollment CANADA | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Region of Enrollment GERMANY | 10 Participants | 10 Participants | 12 Participants | 32 Participants |
| Region of Enrollment JAPAN | 2 Participants | 1 Participants | 5 Participants | 8 Participants |
| Region of Enrollment NETHERLANDS | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment POLAND | 7 Participants | 8 Participants | 5 Participants | 20 Participants |
| Region of Enrollment SPAIN | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Region of Enrollment UNITED STATES | 20 Participants | 21 Participants | 21 Participants | 62 Participants |
| Sex: Female, Male Female | 30 Participants | 28 Participants | 25 Participants | 83 Participants |
| Sex: Female, Male Male | 21 Participants | 22 Participants | 25 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 | 1 / 50 | 0 / 28 | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 21 / 50 | 31 / 51 | 22 / 50 | 12 / 28 | 12 / 30 | 11 / 28 |
| serious Total, serious adverse events | 1 / 50 | 1 / 51 | 4 / 50 | 0 / 28 | 1 / 30 | 1 / 28 |
Outcome results
Primary
Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16
HiSCR50 was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.
Time frame: Week 16
Population: The full analysis set (FAS) included all randomized participants who received at least one administration of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 | 37.1 Percentage of participants |
| Part 1: Bermekimab (Week 0-16) | Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 | 37.1 Percentage of participants |
| Part 1: Adalimumab (Week 0-16) | Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 | 57.1 Percentage of participants |
Secondary
Number of Participants With Antibodies to Bermekimab
Number of participants with antibodies to bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.
Time frame: From baseline up to Week 36
Population: The immunogenicity analysis set included all participants who received at least 1 dose of bermekimab and who had at least 1 sample obtained after their first dose of bermekimab for the detection of antibodies to bermekimab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Placebo (Week 0-16) | Number of Participants With Antibodies to Bermekimab | 16 Participants |
Secondary
Part 1: 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 Week 16
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.
Time frame: Baseline, Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: 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 Week 16 | -1.00 scores on a scale | Standard Deviation 2.461 |
| Part 1: Bermekimab (Week 0-16) | Part 1: 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 Week 16 | -0.41 scores on a scale | Standard Deviation 2.374 |
| Part 1: Adalimumab (Week 0-16) | Part 1: 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 Week 16 | -1.96 scores on a scale | Standard Deviation 2.326 |
Secondary
Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16
IHS4 was a dynamic severity assessment of HS. IHS4 score was arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Higher scores indicate more severity.
Time frame: Baseline up to Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16 | -5.5 scores on a scale | Standard Deviation 10.38 |
| Part 1: Bermekimab (Week 0-16) | Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16 | -10.14 scores on a scale | Standard Deviation 13.36 |
| Part 1: Adalimumab (Week 0-16) | Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16 | -12.6 scores on a scale | Standard Deviation 9.15 |
Secondary
Part 1: Change From Baseline in Number of Abscess at Week 16
Change from baseline in number of abscess at Week 16 was reported.
Time frame: Baseline, Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Change From Baseline in Number of Abscess at Week 16 | -0.86 Abscess | Standard Deviation 1.9 |
| Part 1: Bermekimab (Week 0-16) | Part 1: Change From Baseline in Number of Abscess at Week 16 | -0.83 Abscess | Standard Deviation 3.071 |
| Part 1: Adalimumab (Week 0-16) | Part 1: Change From Baseline in Number of Abscess at Week 16 | -1.46 Abscess | Standard Deviation 2.333 |
Secondary
Part 1: Change From Baseline in Number of Draining Fistula at Week 16
Change from baseline in number of draining fistula at Week 16 was reported. Draining fistula was defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Time frame: Baseline, Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Change From Baseline in Number of Draining Fistula at Week 16 | -0.04 fistulas | Standard Deviation 1.915 |
| Part 1: Bermekimab (Week 0-16) | Part 1: Change From Baseline in Number of Draining Fistula at Week 16 | -1.00 fistulas | Standard Deviation 1.626 |
| Part 1: Adalimumab (Week 0-16) | Part 1: Change From Baseline in Number of Draining Fistula at Week 16 | -0.96 fistulas | Standard Deviation 1.575 |
Secondary
Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16
Change from baseline in number of inflammatory nodules at Week 16 was reported. Inflammatory nodules arise from inflamed blood vessels (vasculitis) or adipose tissue (panniculitis).
Time frame: Baseline, Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16 | -3.64 inflammatory nodules | Standard Deviation 5.258 |
| Part 1: Bermekimab (Week 0-16) | Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16 | -4.48 inflammatory nodules | Standard Deviation 7.689 |
| Part 1: Adalimumab (Week 0-16) | Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16 | -5.79 inflammatory nodules | Standard Deviation 4.306 |
Secondary
Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16
Change from baseline in the AN count as Week 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.
Time frame: Baseline, Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16 | -4.50 Abscess and inflammatory nodule | Standard Deviation 5.088 |
| Part 1: Bermekimab (Week 0-16) | Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16 | -5.31 Abscess and inflammatory nodule | Standard Deviation 8.594 |
| Part 1: Adalimumab (Week 0-16) | Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16 | -7.25 Abscess and inflammatory nodule | Standard Deviation 4.774 |
Secondary
Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16
HiSCR75 was defined as at least 75% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.
Time frame: Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16 | 25.7 Percentage of participants |
| Part 1: Bermekimab (Week 0-16) | Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16 | 25.7 Percentage of participants |
| Part 1: Adalimumab (Week 0-16) | Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16 | 40.0 Percentage of participants |
Secondary
Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16
HiSCR90 was defined as at least 90% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.
Time frame: Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16 | 14.3 Percentage of participants |
| Part 1: Bermekimab (Week 0-16) | Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16 | 17.1 Percentage of participants |
| Part 1: Adalimumab (Week 0-16) | Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16 | 22.9 Percentage of participants |
Secondary
Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16
The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. The participant's HS was assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild activity (2) and with at least 2-grade improvement relative to baseline at Week 16 were reported.
Time frame: Baseline, Week 16
Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0) or almost active (1) | 25.7 Percentage of participants |
| Part 1: Placebo (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0) | 11.4 Percentage of participants |
| Part 1: Placebo (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0), or or almost active (1), or mild activity (2) | 28.6 Percentage of participants |
| Part 1: Bermekimab (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0) or almost active (1) | 25.7 Percentage of participants |
| Part 1: Bermekimab (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0) | 17.1 Percentage of participants |
| Part 1: Bermekimab (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0), or or almost active (1), or mild activity (2) | 28.6 Percentage of participants |
| Part 1: Adalimumab (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0) | 20.6 Percentage of participants |
| Part 1: Adalimumab (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0), or or almost active (1), or mild activity (2) | 38.2 Percentage of participants |
| Part 1: Adalimumab (Week 0-16) | Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 | HS-IGA scores of inactive (0) or almost active (1) | 38.2 Percentage of participants |
Secondary
Serum Concentration of Bermekimab
Serum concentration of bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.
Time frame: Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
Population: The pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of bermekimab and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at each specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 0 | 0.00 micrograms per milliliter (mcg/mL) | Standard Deviation 0 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week1 | 51.36 micrograms per milliliter (mcg/mL) | Standard Deviation 20.354 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 4 | 78.46 micrograms per milliliter (mcg/mL) | Standard Deviation 43.897 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 8 | 73.14 micrograms per milliliter (mcg/mL) | Standard Deviation 37.583 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 12 | 72.45 micrograms per milliliter (mcg/mL) | Standard Deviation 39.185 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 16 | 61.81 micrograms per milliliter (mcg/mL) | Standard Deviation 42.092 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 20 | 74.68 micrograms per milliliter (mcg/mL) | Standard Deviation 59.3 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 24 | 89.75 micrograms per milliliter (mcg/mL) | Standard Deviation 50.94 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 28 | 66.30 micrograms per milliliter (mcg/mL) | Standard Deviation 57.219 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 32 | 34.53 micrograms per milliliter (mcg/mL) | Standard Deviation 36.16 |
| Part 1: Placebo (Week 0-16) | Serum Concentration of Bermekimab | Week 36 | 4.63 micrograms per milliliter (mcg/mL) | Standard Deviation 7.576 |