A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderate to Severe Hidradenitis Suppurativa (NCT06956235)

This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. This study consists of a 16-week Double-blind Period and a 100-week Longterm Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension. Each participant will participate in the study for approximately 135 weeks from the time the participant provides documented informed consent through the final contact. (including screening & follow up). There will be 147 participants across 70 centers worldwide.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Johannes S Kern

Key inclusion data

Inclusion Criteria (meets all of): Has signs and symptoms of HS for ? 6 months prior to Screening and a clinical diagnosis of HS at Screening, Has a history of one of the following, as assessed by the investigator, Inadequate response to a course of systemic antibiotics for treatment of HS, Intolerance to or has a contraindication to systemic antibiotics for treatment of HS. Exclusion Criteria (meets any of): Has other active skin conditions that may interfere with the assessment of HS, Has any immune-mediated inflammatory condition that is not well, controlled and which may potentially require biologic therapy, Has a transplanted organ and requires continued systemic immunosuppression.