Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa (HS)

In brief

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)

Key facts

Study ID

NCT06993610

Run by

Zura Bio Inc

People needed

225

Starts

2025-05-16

Expected to finish

2027-04-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• First OC Dermatology Research, Inc. — Irvine, California, United States
• Wallace Medical Group, Inc. — Los Angeles, California, United States
• Northridge Clinical Trials — Northridge, California, United States
• NorCal Clinical Research — Rocklin, California, United States
• Florida Academic Dermatology Center — Coral Gables, Florida, United States
• Skin Care Research, LLC — Hollywood, Florida, United States
• Georgia Skin & Cancer Clinic — Savannah, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Equity Medical LLC (Kentucky) — Bowling Green, Kentucky, United States
• DS Research of Kentucky, LLC — Louisville, Kentucky, United States
• DelRicht LLC — Baton Rouge, Louisiana, United States
• Clinical Trials Management, LLC — Metairie, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Skin Cancer and Dermatology Institute — Reno, Nevada, United States
• Equity Medical — New York, New York, United States
• OptiSkin Medical — New York, New York, United States
• Red River Research Partners — Fargo, North Dakota, United States
• Optima Research — Boardman, Ohio, United States
• ClinOhio Research Services — Columbus, Ohio, United States
• Apex Clinical Research Center — Mayfield Heights, Ohio, United States
• Best Skin Research LLC — Camp Hill, Pennsylvania, United States
• Palmetto Clinical Trial Services — Anderson, South Carolina, United States
• Medical Dermatology Specialists (Phoenix) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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