Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
NCT ID: NCT06993610
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2025-05-16
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tibulizumab Dose A
Subcutaneous injection
Tibulizumab Dose A
Anti BAFF/IL-17 antibody. ZB-106
Tibulizumab Dose B
Subcutaneous injection
Tibulizumab Dose B
Anti BAFF/IL-17 antibody. ZB-106
Placebo
Subcutaneous injection
Placebo
ZB-106 Placebo
Interventions
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Tibulizumab Dose A
Anti BAFF/IL-17 antibody. ZB-106
Tibulizumab Dose B
Anti BAFF/IL-17 antibody. ZB-106
Placebo
ZB-106 Placebo
Eligibility Criteria
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Inclusion Criteria
* ≥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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Zura Bio Inc
INDUSTRY
Responsible Party
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Locations
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Medical Dermatology Specialists (Phoenix)
Phoenix, Arizona, United States
First OC Dermatology Research, Inc.
Irvine, California, United States
Wallace Medical Group, Inc.
Los Angeles, California, United States
NorCal Clinical Research
Rocklin, California, United States
Florida Academic Dermatology Center
Coral Gables, Florida, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, 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
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Skin Cancer and Dermatology Institute
Sparks, Nevada, United States
Equity Medical
New York, New York, United States
Optima Research
Boardman, Ohio, United States
ClinOhio Research Services
Columbus, Ohio, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, United States
Palmetto Clinical Trial Services
Anderson, South Carolina, United States
DelRicht Research
Mt. Pleasant, South Carolina, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
BRCR Global Texas
Katy, Texas, United States
DelRicht Research
Prosper, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Ryan Clinical Research Inc.
Newmarket, Ontario, Canada
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, Canada
Centre de recherche Saint-Louis
Québec, Quebec, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, Canada
RENEW Clinic
Bialystok, , Poland
Provita Sp. z o. o.
Katowice, , Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
Malbork, , Poland
Laser Clinic S.C.
Szczecin, , Poland
Edificio IMIBIC, Reina Sofia University Hospital
Córdoba, , Spain
Gregorio Marañón General University Hospital
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-519736-17-00
Identifier Type: CTIS
Identifier Source: secondary_id
ZB-106-HS-202
Identifier Type: -
Identifier Source: org_study_id