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Active Not Recruiting
NCT06993610
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Conditions: Hidradenitis Suppurativa (HS)
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 225
Sponsor: Zura Bio Inc
Location: Medical Dermatology Specialists (Phoenix) Phoenix Arizona
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
Source: ClinicalTrials.gov (NCT06993610). StuddyBuddy aggregates publicly available trial information.