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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID: NCT04988308
Run by: Janssen Research & Development, LLC
People needed: 151
Starts: 2021-10-12
Expected to finish: 2022-11-23
Last updated by the study team: 2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

First OC Dermatology — Fountain Valley, California, United States
Center for Dermatology Clinical Research — Fremont, California, United States
Wallace Medical Group, Inc. — Los Angeles, California, United States
Renstar Medical Research — Ocala, Florida, United States
Forcare Clinical Research, Inc. — Tampa, Florida, United States
Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
Indiana Clinical Trial Center — Plainfield, Indiana, 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
Somerset Skin Centre — Troy, Michigan, United States
Minnesota Clinical Study Center — New Brighton, Minnesota, United States
JDR Dermatology Research — Las Vegas, Nevada, United States
ActivMed Practices & Research — Portsmouth, New Hampshire, United States
Wright State Physicians Health Center — Dayton, Ohio, United States
Penn State Milton S. Hershey Medical Ctr. — Hershey, Pennsylvania, United States
Clinical Partners — Johnston, Rhode Island, United States
Arlington Center for Dermatology — Arlington, Texas, United States
Modern Research Associates — Dallas, Texas, United States
Center for Clinical Studies — Houston, Texas, United States
Progressive Clinical Research — San Antonio, Texas, United States
Clinical Trials SA Pty Ltd — Campbelltown, Australia
Holdsworth House — Darlinghurst, Australia
Sinclair Dermatology — East Melbourne, Australia
Medical Dermatology Specialists — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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