Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
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
225 participants
May 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria7
- 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
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Interventions
Anti BAFF/IL-17 antibody. ZB-106
Anti BAFF/IL-17 antibody. ZB-106
ZB-106 Placebo
Locations(56)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06993610