Overview
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
Inclusion Criteria:
- Male or female, 18 to 70 years of age
- ≥6-month history of Hidradenitis suppurativa (HS)
- Total AN (abscesse 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