Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

NCT06993610 · tracked via the Priya Life Science USA tracker

Sponsor

Zura Bio Inc

Phase

Phase 2

Started

2025-05-16

Last updated

2026-06-30

Condition(s) studied

Hidradenitis Suppurativa (HS)

Investigational drug(s) / intervention(s)

Tibulizumab Dose ATibulizumab Dose BPlacebo

Tibulizumab Dose A: Anti BAFF/IL-17 antibody. ZB-106

Tibulizumab Dose B: Anti BAFF/IL-17 antibody. ZB-106

Placebo: ZB-106 Placebo

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

[Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks — Week 16
AN count is calculated based on the sum of the abscesses and inflammatory nodules across different anatomical areas

Trial sites (61)

Facility	City	Region
Medical Dermatology Specialists (Phoenix)	Phoenix	Arizona
First OC Dermatology Research, Inc.	Irvine	California
Wallace Medical Group, Inc.	Los Angeles	California
Northridge Clinical Trials	Northridge	California
NorCal Clinical Research	Rocklin	California
Florida Academic Dermatology Center	Coral Gables	Florida
Skin Care Research, LLC	Hollywood	Florida
Georgia Skin & Cancer Clinic	Savannah	Georgia
Indiana University School of Medicine	Indianapolis	Indiana
The Indiana Clinical Trials Center	Plainfield	Indiana
Equity Medical LLC (Kentucky)	Bowling Green	Kentucky
DS Research of Kentucky, LLC	Louisville	Kentucky
DelRicht LLC	Baton Rouge	Louisiana
Clinical Trials Management, LLC	Metairie	Louisiana
Beth Israel Deaconess Medical Center	Boston	Massachusetts
MediSearch Clinical Trials	Saint Joseph	Missouri
Skin Cancer and Dermatology Institute	Reno	Nevada
Equity Medical	New York	New York
OptiSkin Medical	New York	New York
Red River Research Partners	Fargo	North Dakota
Optima Research	Boardman	Ohio
ClinOhio Research Services	Columbus	Ohio
Apex Clinical Research Center	Mayfield Heights	Ohio
Best Skin Research LLC	Camp Hill	Pennsylvania
Palmetto Clinical Trial Services	Anderson	South Carolina
DelRicht Research	Mt. Pleasant	South Carolina
International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
Dermatology Treatment and Research Center	Dallas	Texas
BRCR Global Texas	Katy	Texas
DelRicht Research	Prosper	Texas
Progressive Clinical Research	San Antonio	Texas
Frontier Dermatology	Mill Creek	Washington
University of Washington Medical Center	Seattle	Washington
Dermatology Specialists of Spokane	Spokane	Washington
Ryan Clinical Research Inc.	Newmarket	Ontario
North York Research Inc	North York	Ontario
York Dermatology Clinic & Research Centre	Richmond Hill	Ontario
Centre de recherche Saint-Louis	Québec	Quebec
Saskatoon Dermatology Centre	Saskatoon	Saskatchewan
Fachklinik Bad Bentheim	Bad Bentheim	Germany

+ 21 more sites — see the full list on the official registry below.

More Zura Bio Inc trials in the USA

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) Active, not recruiting

Other trials for the same condition

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Recruiting

A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa Recruiting

A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa Recruiting

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib Recruiting

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06993610 on ClinicalTrials.gov ↗ ← All trials in the USA