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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    290
  • sponsor
    Janssen Research & Development, LLC
Updated on 18 June 2022
abscess
adalimumab

Summary

The purpose of this study is to evaluate the dose-response of bermekimab efficacy 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. 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). 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 evaluation(s). The total duration of study participation will be up to 42 weeks.

Details
Condition Hidradenitis Suppurativa
Treatment Placebo, Adalimumab, Bermekimab
Clinical Study IdentifierNCT04988308
SponsorJanssen Research & Development, LLC
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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