A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

18518

This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.

2023-10-23

2025-08-01

2026-07-01

Recruiting

Early phase I

350

Inclusion Criteria: * Have a diagnosis of HS for at least 12 months. * Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III. * Have an (abscess plus inflammatory nodule) count of at least 5. * Agree to use topical antiseptics daily. * Had an inadequate response or intolerance to a 28-day course of oral antibiotics. Exclusion Criteria: * Have more than 20 draining fistulae. * Have had surgical treatment for HS in the last 4 weeks before randomization. * Have an active skin disease or condition, that could interfere with the assessment of HS. * Have a current or recent acute, active infection. * Are immunocompromised. * Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 2b', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

2024-04-16