a study of bermekimab for the treatment of participants with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe hidradenitis suppurativa (hs).

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