Clinical trial NCT04988308: A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16
timeFrame: Week 16
measure: Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16
timeFrame: Week 16
measure: Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16
timeFrame: Baseline, Week 16
measure: Part 1: Change From Baseline in Number of Abscess at Week 16
timeFrame: Baseline, Week 16
measure: Part 1: Change From Baseline in Number of Draining Fistula at Week 16
timeFrame: Baseline, Week 16
measure: Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16
timeFrame: Baseline, Week 16
measure: Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16
timeFrame: Baseline up to Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: Serum Concentration of Bermekimab
timeFrame: Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
measure: Number of Participants With Antibodies to Bermekimab
timeFrame: From baseline up to Week 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc.
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research, Inc.
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Beverly
country: United States
facility: Allcutis Research
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Clarkston
country: United States
facility: Clarkston Dermatology & Vein Center, PLLC
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research
state: New Hampshire
city: Dayton
country: United States
facility: Wright State Physicians Health Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Ctr.
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners
state: Rhode Island
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Campbelltown
country: Australia
facility: Clinical Trials SA Pty Ltd
city: Darlinghurst
country: Australia
facility: Holdsworth House
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Barrie
country: Canada
facility: SimcoMed Health Ltd
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Quebec
country: Canada
facility: Centre De Recherche Dermatologique Du Quebec Metropolitan
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Kiel
country: Germany
facility: Universitaets-Hautklinik Kiel
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital
city: Nishinomiya
country: Japan
facility: Meiwa Hospital
city: Obihiro-shi
country: Japan
facility: Takagi Dermatology Clinic
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Lódź
country: Poland
facility: Centrum Medyczne Dermoklinika
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
city: Wrocław
country: Poland
facility: Wromedica
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Clinica Univ. de Navarra
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Pontevedra
country: Spain
facility: Hosp. Provincial de Pontevedra
city: Valencia
country: Spain
facility: Hosp. de Manises
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: