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
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Medical Dermatology Specialists (Phoenix)
RECRUITING
Phoenix
California
First OC Dermatology Research, Inc.
RECRUITING
Irvine
Wallace Medical Group, Inc.
RECRUITING
Los Angeles
NorCal Clinical Research
RECRUITING
Rocklin
Florida
Florida Academic Dermatology Center
RECRUITING
Coral Gables
Georgia
Georgia Skin & Cancer Clinic
RECRUITING
Savannah
Indiana
The Indiana Clinical Trials Center
RECRUITING
Plainfield
Kentucky
Equity Medical LLC (Kentucky)
RECRUITING
Bowling Green
DS Research of Kentucky, LLC
RECRUITING
Louisville
Louisiana
DelRicht LLC
RECRUITING
Baton Rouge
Clinical Trials Management, LLC
RECRUITING
Metairie
Missouri
MediSearch Clinical Trials
RECRUITING
Saint Joseph
Nevada
Skin Cancer and Dermatology Institute
RECRUITING
Sparks
New York
Equity Medical
RECRUITING
New York
Ohio
Optima Research
RECRUITING
Boardman
ClinOhio Research Services
RECRUITING
Columbus
Apex Clinical Research Center
RECRUITING
Mayfield Heights
South Carolina
Palmetto Clinical Trial Services
RECRUITING
Anderson
DelRicht Research
RECRUITING
Mt. Pleasant
Tennessee
International Clinical Research - Tennessee LLC
RECRUITING
Murfreesboro
Texas
BRCR Global Texas
RECRUITING
Katy
DelRicht Research
RECRUITING
Prosper
Progressive Clinical Research
RECRUITING
San Antonio
Washington
University of Washington Medical Center
RECRUITING
Seattle
Dermatology Specialists of Spokane
RECRUITING
Spokane
Other Locations
Canada
Ryan Clinical Research Inc.
RECRUITING
Newmarket
Centre de recherche Saint-Louis
RECRUITING
Québec
Saskatoon Dermatology Centre
RECRUITING
Saskatoon
Poland
Provita Sp. z o. o.
RECRUITING
Katowice
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
RECRUITING
Malbork
Laser Clinic S.C.
RECRUITING
Szczecin
Spain
Gregorio Marañón General University Hospital
RECRUITING
Madrid
Contact Information
Primary
Chief Medical Officer
clinicaltrial@zurabio.com
702-825-9872
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2027-03
Participants
Target number of participants: 180
Treatments
Experimental: Tibulizumab Dose A
Subcutaneous injection
Experimental: Tibulizumab Dose B
Subcutaneous injection
Placebo_comparator: Placebo
Subcutaneous injection
Related Therapeutic Areas
Sponsors
Leads: Zura Bio Inc