Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
TibuSHIELD
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
2 other identifiers
interventional
225
6 countries
56
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, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2025
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2025
CompletedFirst Submitted
Initial submission to the registry
May 19, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 12, 2026
February 1, 2026
1.5 years
May 19, 2025
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
[Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks
AN count is calculated based on the sum of the abscesses and inflammatory nodules across different anatomical areas
Week 16
Secondary Outcomes (6)
[Period 1] Achieving HiSCR50 at Week 16
Week 16
[Period 1] Achieving HiSCR75 at Week 16
Week 16
[Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16
Week 16
[Period 1] Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16
Week 16
[Period 1] Absolute change from baseline in Skin Pain Numeric Rating Scale (NRS) at Week 16
Week 16
- +1 more secondary outcomes
Study Arms (3)
Tibulizumab Dose A
EXPERIMENTALSubcutaneous injection
Tibulizumab Dose B
EXPERIMENTALSubcutaneous injection
Placebo
PLACEBO COMPARATORSubcutaneous injection
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zura Bio Inclead
Study Sites (56)
Medical Dermatology Specialists (Phoenix)
Phoenix, Arizona, 85006, United States
First OC Dermatology Research, Inc.
Irvine, California, 92614, United States
Wallace Medical Group, Inc.
Los Angeles, California, 90056, United States
Northridge Clinical Trials
Northridge, California, 91325, United States
NorCal Clinical Research
Rocklin, California, 95765, United States
Florida Academic Dermatology Center
Coral Gables, Florida, 33134, United States
Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Equity Medical LLC (Kentucky)
Bowling Green, Kentucky, 42104, United States
DS Research of Kentucky, LLC
Louisville, Kentucky, 40241, United States
DelRicht LLC
Baton Rouge, Louisiana, 70809, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509, United States
Equity Medical
New York, New York, 10023, United States
OptiSkin Medical
New York, New York, 10128, United States
Optima Research
Boardman, Ohio, 44512, United States
ClinOhio Research Services
Columbus, Ohio, 43213, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124, United States
Best Skin Research LLC
Camp Hill, Pennsylvania, 17011, United States
Palmetto Clinical Trial Services
Anderson, South Carolina, 29625, United States
DelRicht Research
Mt. Pleasant, South Carolina, 29464, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130, United States
BRCR Global Texas
Katy, Texas, 77450, United States
DelRicht Research
Prosper, Texas, 75078, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Frontier Dermatology
Mill Creek, Washington, 98012, United States
University of Washington Medical Center
Seattle, Washington, 98164, United States
Dermatology Specialists of Spokane
Spokane, Washington, 99202, United States
Ryan Clinical Research Inc.
Newmarket, Ontario, L3Y 5G8, Canada
North York Research Inc
North York, Ontario, M2J 5B2, Canada
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, L4B 1L1, Canada
Centre de recherche Saint-Louis
Québec, Quebec, G1W 4R4, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T 0G3, Canada
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Klinikum Darmstadt
Darmstadt, 64283, Germany
University Hospital Dresden
Dresden, 01307, Germany
Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
Hamburg, 20251, Germany
University Clinic Dermatology Heidelberg
Heidelberg, 69120, Germany
Klinik und Poliklinik für Dermatologie und Allergologie
München, 80337, Germany
University Hospital Muenster - Münster
Münster, 48149, Germany
Semmelweis University
Budapest, 1085, Hungary
University of Debrecen
Debrecen, 4032, Hungary
RENEW Clinic
Bialystok, 15-797, Poland
Provita Centrum Medyczne Sp. z o.o. Katowice
Katowice, 40-611, Poland
Provita Sp. z o. o.
Katowice, 40-611, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o
Malbork, 82200, Poland
SOLUMED
Poznan, 60-425, Poland
Laser Clinic S.C.
Szczecin, 70-332, Poland
Manufaktura Zdrowia i Urody
Warsaw, 02-922, Poland
Edificio IMIBIC, Reina Sofia University Hospital
Córdoba, 14004, Spain
Gregorio Marañón General University Hospital
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2025
First Posted
May 29, 2025
Study Start
May 16, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share