A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— LYRA  

Official title:

A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04988308
• Other study ID #: CR109063
• Secondary ID: 2020-002607-1977
• Status: Terminated
• Phase: Phase 2
• Start date: October 12, 2021
• Est. completion date: November 23, 2022

Study information

• Verified date: October 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 151
• Est. completion date: November 23, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Bermekimab
Bermekimab will be administered subcutaneously.
• Adalimumab
Adalimumab will be administered subcutaneously.
• Placebo
Placebo will be administered subcutaneously.

Locations

Country	Name	City	State
Australia	Clinical Trials SA Pty Ltd	Campbelltown
Australia	Holdsworth House	Darlinghurst
Australia	Sinclair Dermatology	East Melbourne
Australia	Veracity Clinical Research	Woolloongabba
Canada	SimcoMed Health Ltd	Barrie	Ontario
Canada	Centre De Recherche Dermatologique Du Quebec Metropolitan	Quebec
Canada	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario
Canada	Alliance Clinical Trials	Waterloo	Ontario
Germany	Katholisches Klinikum Bochum gGmbH	Bochum
Germany	Universitaetsklinik Erlangen	Erlangen
Germany	Universitatsklinikum Frankfurt	Frankfurt
Germany	Universitaets-Hautklinik Kiel	Kiel
Germany	Universitaetsmedizin Mainz	Mainz
Germany	Universitätsklinikum Würzburg	Würzburg
Japan	Fukuoka University Hospital	Fukuoka
Japan	Nagoya City University Hospital	Nagoya
Japan	University of the Ryukyus Hospital	Nakagami-gun
Japan	Meiwa Hospital	Nishinomiya
Japan	Takagi Dermatology Clinic	Obihiro-shi
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Poland	Centrum Medyczne Dermoklinika	Lódz
Poland	Royalderm Agnieszka Nawrocka	Warsaw
Poland	Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spólka Partnerska	Wroclaw
Poland	Wromedica	Wroclaw
Spain	Hosp. Univ. Germans Trias I Pujol	Badalona
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Clinica Univ. de Navarra	Madrid
Spain	Hosp. Gral. Univ. Gregorio Maranon	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Provincial de Pontevedra	Pontevedra
Spain	Hosp. de Manises	Valencia
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Allcutis Research	Beverly	Massachusetts
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Clarkston Dermatology & Vein Center, PLLC	Clarkston	Michigan
United States	Modern Research Associates	Dallas	Texas
United States	Wright State Physicians Health Center	Dayton	Ohio
United States	First OC Dermatology	Fountain Valley	California
United States	Center for Dermatology Clinical Research	Fremont	California
United States	Penn State Milton S. Hershey Medical Ctr.	Hershey	Pennsylvania
United States	Center for Clinical Studies	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Clinical Partners	Johnston	Rhode Island
United States	JDR Dermatology Research	Las Vegas	Nevada
United States	Wallace Medical Group, Inc.	Los Angeles	California
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Renstar Medical Research	Ocala	Florida
United States	Medical Dermatology Specialists	Phoenix	Arizona
United States	Indiana Clinical Trial Center	Plainfield	Indiana
United States	ActivMed Practices & Research	Portsmouth	New Hampshire
United States	Progressive Clinical Research	San Antonio	Texas
United States	Forcare Clinical Research, Inc.	Tampa	Florida
United States	Somerset Skin Centre	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Japan,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 16
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.	Week 16
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.	Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16
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).	Baseline, Week 16
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.	Baseline up to Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
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.	From baseline up to Week 36