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

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Bermekimab; Drug: Adalimumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04988308

2020-002607-19 (EudraCT Number)

77474462HDS2001 (Other Identifier)

CR109063

Details and patient eligibility

About

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

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 7 patient groups, including a placebo group

Part 1 (Group 1): Placebo

Placebo Comparator group

Description:

Participants will receive placebo subcutaneously (SC) at Week 0 through Week 15. At Week 16, participants will cross over to receive bermekimab dose 1 SC every week thereafter through Week 31.

Treatment:

Drug: Placebo

Drug: Bermekimab

Part 1 (Group 2): Adalimumab

Active Comparator group

Description:

Participants will receive adalimumab 160 milligrams (mg) SC at Week 0, placebo SC at Week 1, followed by adalimumab 80 mg SC and placebo SC at Weeks 2 and 3. Participants will then receive adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31.

Treatment:

Drug: Adalimumab

Drug: Placebo

Part 1 (Group 3): Bermekimab Dose 1

Experimental group

Description:

Participants will receive bermekimab dose 1 SC and placebo SC at Week 0, followed by bermekimab dose 1 SC at Week 1 and every week thereafter through Week 31.

Treatment:

Drug: Placebo

Drug: Bermekimab

Part 2 (Group 1): Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC from Week 0 through Week 11. At Week 12, participants will cross over to receive bermekimab dose 1 SC weekly through Week 31.

Treatment:

Drug: Placebo

Drug: Bermekimab

Part 2 (Group 2): Bermekimab Dose 1

Experimental group

Description:

Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.

Treatment:

Drug: Bermekimab

Part 2 (Group 3): Bermekimab Dose 1

Experimental group

Description:

Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 1 SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.

Treatment:

Drug: Placebo

Drug: Bermekimab

Part 2 (Group 4): Bermekimab Dose 2

Experimental group

Description:

Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 2 SC and placebo SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.

Treatment:

Drug: Placebo

Drug: Bermekimab