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

• Status: Recruiting
• Trial end date: 2024-01-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Adalimumab

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