Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Trial Parameters
Brief Summary
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
Eligibility Criteria
Inclusion Criteria: * Male or female, 18 to 70 years of age * ≥6-month history of Hidradenitis suppurativa (HS) * Total AN (abscess and inflammatory nodule) count ≥5 * HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III Exclusion Criteria: * Draining tunnel count \>20 * Presence of another inflammatory condition or a skin condition that may interfere with study assessments * Known to have immune deficiency or is immunocompromised * Evidence or suspicion of active or latent tuberculosis * History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, serious or life-threatening infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks * Has active systemic candidiasis * Unable to tolerate subcutaneous drug administration