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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002607-19 | EudraCT Number | ||
| 77474462HDS2001 | Other Identifier | Janssen Research & Development, LLC |
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Study has been prematurely terminated as the Interim Analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint.
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The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Group 1): Placebo | Placebo Comparator | Participants will receive placebo subcutaneously (SC) at Week 0 through Week 15. At Week 16, participants will cross over to receive bermekimab dose 1 SC every week thereafter through Week 31. |
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| Part 1 (Group 2): Adalimumab | Active Comparator | Participants will receive adalimumab 160 milligrams (mg) SC at Week 0, placebo SC at Week 1, followed by adalimumab 80 mg SC and placebo SC at Weeks 2 and 3. Participants will then receive adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31. |
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| Part 1 (Group 3): Bermekimab Dose 1 | Experimental | Participants will receive bermekimab dose 1 SC and placebo SC at Week 0, followed by bermekimab dose 1 SC at Week 1 and every week thereafter through Week 31. |
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| Part 2 (Group 1): Placebo | Placebo Comparator | Participants will receive placebo SC from Week 0 through Week 11. At Week 12, participants will cross over to receive bermekimab dose 1 SC weekly through Week 31. |
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| Part 2 (Group 2): Bermekimab Dose 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bermekimab | Drug | Bermekimab will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | United States | ||
| First OC Dermatology |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Part 1: Bermekimab (Week 0-36) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo Controlled Period (Weeks 0-16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 12, 2022 | Oct 12, 2023 |
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Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31. |
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| Part 2 (Group 3): Bermekimab Dose 1 | Experimental | Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 1 SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31. |
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| Part 2 (Group 4): Bermekimab Dose 2 | Experimental | Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 2 SC and placebo SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31. |
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| Adalimumab | Drug | Adalimumab will be administered subcutaneously. |
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| Placebo | Drug | Placebo will be administered subcutaneously. |
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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. |
| Week 16 |
| 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. | Baseline, Week 16 |
| Part 1: Change From Baseline in Number of Abscess at Week 16 | Change from baseline in number of abscess at Week 16 was reported. | Baseline, Week 16 |
| 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. | Baseline, Week 16 |
| 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). | Baseline, Week 16 |
| 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. | Baseline up to Week 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 | 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. | Baseline, Week 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 | 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. | Baseline, Week 16 |
| 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. | Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 |
| 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. | From baseline up to Week 36 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Center for Dermatology Clinical Research | Fremont | California | 94538 | United States |
| Wallace Medical Group, Inc. | Los Angeles | California | 90056 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Forcare Clinical Research, Inc. | Tampa | Florida | 33613 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46256 | United States |
| Indiana Clinical Trial Center | Plainfield | Indiana | 46168 | United States |
| Allcutis Research | Beverly | Massachusetts | 01915 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Clarkston Dermatology & Vein Center, PLLC | Clarkston | Michigan | 48346 | United States |
| Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | United States |
| JDR Dermatology Research | Las Vegas | Nevada | 89148 | United States |
| ActivMed Practices & Research | Portsmouth | New Hampshire | 03801 | United States |
| Wright State Physicians Health Center | Dayton | Ohio | 45324 | United States |
| Penn State Milton S. Hershey Medical Ctr. | Hershey | Pennsylvania | 17033 | United States |
| Clinical Partners | Johnston | Rhode Island | 02919 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| Modern Research Associates | Dallas | Texas | 75231 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Clinical Trials SA Pty Ltd | Campbelltown | 5074 | Australia |
| Holdsworth House | Darlinghurst | 2010 | Australia |
| Sinclair Dermatology | East Melbourne | 3002 | Australia |
| Veracity Clinical Research | Woolloongabba | 4102 | Australia |
| SimcoMed Health Ltd | Barrie | Ontario | L4M 7G1 | Canada |
| York Dermatology Clinic and Research Centre | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Alliance Clinical Trials | Waterloo | Ontario | N2J 1C4 | Canada |
| Centre De Recherche Dermatologique Du Quebec Metropolitan | Québec | Quebec | G1V 4X7 | Canada |
| Katholisches Klinikum Bochum gGmbH | Bochum | 44791 | Germany |
| Universitaetsklinik Erlangen | Erlangen | 91054 | Germany |
| Universitatsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Universitaets-Hautklinik Kiel | Kiel | 24105 | Germany |
| Universitaetsmedizin Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Nagoya City University Hospital | Nagoya | 467-8602 | Japan |
| University of the Ryukyus Hospital | Nakagami-gun | 903-0215 | Japan |
| Meiwa Hospital | Nishinomiya | 663-8186 | Japan |
| Takagi Dermatology Clinic | Obihiro-shi | 080-0013 | Japan |
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 CE | Netherlands |
| Centrum Medyczne Dermoklinika | Lódź | 90-436 | Poland |
| Royalderm Agnieszka Nawrocka | Warsaw | 02-962 | Poland |
| Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska | Wroclaw | 50566 | Poland |
| Wromedica | Wroclaw | 51-685 | Poland |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Clinica Univ. de Navarra | Madrid | 28027 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Provincial de Pontevedra | Pontevedra | 36003 | Spain |
| Hosp. de Manises | Valencia | 46940 | Spain |
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. |
| FG002 | 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. |
| FG003 | Part 1: Placebo Then Bermekimab (Week 17-36) | Participants who received placebo during placebo controlled period and then 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 31 in Part 1. All participants were followed for safety through Week 36. |
| FG004 | Part 1: Bermekimab (Week 17-36) | Participants who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3*350 mg) as SC injection every week thereafter through Week 31. All participants were followed for safety through Week 36. |
| FG005 | Part 1: Adalimumab (Week 17-36) | Participants who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All participants were followed for safety through Week 36. |
| Full- Analysis Set (FAS) |
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| COMPLETED |
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| NOT COMPLETED |
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| Active Treatment+Safety F-U (Week 17-36) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| 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. | The full analysis set (FAS) included all randomized participants who received at least one administration of study intervention. | Posted | Number | Percentage of participants | Week 16 |
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| 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. | The FAS included all randomized participants who received at least one administration of study intervention. | Posted | Number | Percentage of participants | Week 16 |
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| 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. | The FAS included all randomized participants who received at least one administration of study intervention. | Posted | Number | Percentage of participants | Week 16 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Abscess and inflammatory nodule | Baseline, Week 16 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Abscess | Baseline, Week 16 |
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| 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. | 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. | Posted | Mean | Standard Deviation | fistulas | Baseline, Week 16 |
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| 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). | 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. | Posted | Mean | Standard Deviation | inflammatory nodules | Baseline, Week 16 |
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| 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline up to Week 16 |
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| 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. | 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. | Posted | Number | Percentage of participants | Baseline, Week 16 |
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| 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 16 |
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| 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. | 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. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 |
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| 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. | 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. | Posted | Count of Participants | Participants | From baseline up to Week 36 |
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Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36
The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 50 | 1 | 50 | 21 | 50 |
| EG001 | 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. | 0 | 51 | 1 | 51 | 31 | 51 |
| EG002 | 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. | 1 | 50 | 4 | 50 | 22 | 50 |
| EG003 | Part 1: Placebo Then Bermekimab (Week 17-36) | Participants who received placebo during placebo controlled period and then 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 31 in Part 1. All participants were followed for safety through Week 36. | 0 | 28 | 0 | 28 | 12 | 28 |
| EG004 | Part 1: Bermekimab (Week 17-36) | Participants who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3*350 mg) as SC injection every week thereafter through Week 31. All participants were followed for safety through Week 36. | 0 | 30 | 1 | 30 | 12 | 30 |
| EG005 | Part 1: Adalimumab (Week 17-36) | Participants who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All participants were followed for safety through Week 36. | 0 | 28 | 1 | 28 | 11 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 24.1 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Skin Bacterial Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Arterial Occlusive Disease | Vascular disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Injection Site Pruritus | General disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Bacterial Vaginosis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Non-systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Non-systematic Assessment |
|
As per change in planned analysis, Part 2 and some secondary efficacy analysis of Part 1 in 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 collected in this results summary.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research Dermatology | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2022 | Oct 12, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604877 | bermekimab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Lost to Follow-up |
|
| Other |
|
| Study terminated by sponsor |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| CANADA |
|
| GERMANY |
|
| JAPAN |
|
| NETHERLANDS |
|
| POLAND |
|
| SPAIN |
|
| UNITED STATES |
|
|
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|
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.
|
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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. |
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|
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.
| OG002 | 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. |
|
|
| OG001 |
| Part 1: Bermekimab (Week 0-16) |
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. |
| OG002 | 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. |
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