A Phase 2, Multi-Center Study Consisting of a Randomized, Placebo-Controlled Period, Followed by an Open-Label Extension Period to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Hidradenitis Suppurativa
Zura Bio Inc
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
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 requir…
Interventions
- BiologicalTibulizumab Dose A
Anti BAFF/IL-17 antibody. ZB-106
- BiologicalTibulizumab Dose B
Anti BAFF/IL-17 antibody. ZB-106
- OtherPlacebo
ZB-106 Placebo
Locations (56)
- Medical Dermatology Specialists (Phoenix)Phoenix, Arizona
- First OC Dermatology Research, Inc.Irvine, California
- Wallace Medical Group, Inc.Los Angeles, California
- Northridge Clinical TrialsNorthridge, California
- NorCal Clinical ResearchRocklin, California
- Florida Academic Dermatology CenterCoral Gables, Florida