Status:
RECRUITING
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Lead Sponsor:
Zura Bio Inc
Conditions:
Hidradenitis Suppurativa (HS)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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, follow...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06993610
Start Date
May 16 2025
End Date
March 1 2027
Last Update
December 11 2025
Active Locations (48)
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1
Medical Dermatology Specialists (Phoenix)
Phoenix, Arizona, United States, 85006
2
First OC Dermatology Research, Inc.
Irvine, California, United States, 92614
3
Wallace Medical Group, Inc.
Los Angeles, California, United States, 90056
4
NorCal Clinical Research
Rocklin, California, United States, 95765