Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

Last updated: February 10, 2026
Sponsor: Zura Bio Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Rosacea

Rash

Allergy

Treatment

Placebo

Tibulizumab Dose A

Tibulizumab Dose B

Clinical Study ID

NCT06993610
ZB-106-HS-202
2024-519736-17-00
  • Ages 18-70
  • All Genders

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 Criteria

Inclusion

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 IIor III

Exclusion

Exclusion Criteria:

  • Draining tunnel count >20

  • Presence of another inflammatory condition or a skin condition that may interferewith 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 chronicantibiotic use, serious or life-threatening infection within 2 months, or had aninfection requiring systemic antibiotics within 2 weeks

  • Has active systemic candidiasis

  • Unable to tolerate subcutaneous drug administration

Study Design

Total Participants: 225
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 16, 2025
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Dr. S. K. Siddha Medicine Professional Corporation

    Newmarket 6087701, Ontario 6093943 L3Y 5G8
    Canada

    Active - Recruiting

  • Ryan Clinical Research Inc.

    Newmarket 6087701, Ontario 6093943 L3Y 5G8
    Canada

    Active - Recruiting

  • North York Research Inc

    North York, Ontario 6093943 M2J 5B2
    Canada

    Active - Recruiting

  • York Dermatology Clinic & Research Centre

    Richmond Hill 6122091, Ontario 6093943 L4B 1L1
    Canada

    Active - Recruiting

  • Centre de recherche Saint-Louis

    Québec, Quebec G1W 4R4
    Canada

    Site Not Available

  • Centre de recherche Saint-Louis

    Québec 6325494, Quebec 6115047 G1W 4R4
    Canada

    Active - Recruiting

  • Saskatoon Dermatology Centre

    Saskatoon, Saskatchewan S7T 0G3
    Canada

    Site Not Available

  • Saskatoon Dermatology Centre

    Saskatoon 6141256, Saskatchewan 6141242 S7T 0G3
    Canada

    Active - Recruiting

  • Fachklinik Bad Bentheim

    Bad Bentheim 2953552, 48455
    Germany

    Active - Recruiting

  • Klinikum Darmstadt

    Darmstadt 2938913, 64283
    Germany

    Active - Recruiting

  • University Hospital Dresden

    Dresden 2935022, 01307
    Germany

    Active - Recruiting

  • Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

    Hamburg 2911298, 20251
    Germany

    Active - Recruiting

  • University Clinic Dermatology Heidelberg

    Heidelberg 2907911, 69120
    Germany

    Active - Recruiting

  • Klinik und Poliklinik für Dermatologie und Allergologie

    München 2867711, 80337
    Germany

    Active - Recruiting

  • University Hospital Muenster - Münster

    Münster 2867543, 48149
    Germany

    Active - Recruiting

  • Semmelweis University

    Budapest 3054643, 1085
    Hungary

    Active - Recruiting

  • University of Debrecen

    Debrecen 721472, 4032
    Hungary

    Active - Recruiting

  • RENEW Clinic

    Bialystok 776069, 15-797
    Poland

    Active - Recruiting

  • Provita Centrum Medyczne Sp. z o.o. Katowice

    Katowice 3096472, 40-611
    Poland

    Active - Recruiting

  • Provita Sp. z o. o.

    Katowice 3096472, 40-611
    Poland

    Active - Recruiting

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o

    Malbork 3092472, 82200
    Poland

    Active - Recruiting

  • SOLUMED

    Poznan 3088171, 60-425
    Poland

    Active - Recruiting

  • Laser Clinic S.C.

    Szczecin 3083829, 70-332
    Poland

    Active - Recruiting

  • Manufaktura Zdrowia i Urody

    Warsaw 756135, 02-922
    Poland

    Active - Recruiting

  • Edificio IMIBIC, Reina Sofia University Hospital

    Córdoba 2519240, 14004
    Spain

    Active - Recruiting

  • Gregorio Marañón General University Hospital

    Madrid 3117735, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza 3104324, 50009
    Spain

    Active - Recruiting

  • Medical Dermatology Specialists (Phoenix)

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Active - Recruiting

  • Wallace Medical Group, Inc.

    Los Angeles, California 90056
    United States

    Site Not Available

  • NorCal Clinical Research

    Rocklin, California 95765
    United States

    Site Not Available

  • First OC Dermatology Research, Inc.

    Irvine 5359777, California 5332921 92614
    United States

    Active - Recruiting

  • Wallace Medical Group, Inc.

    Los Angeles 5368361, California 5332921 90056
    United States

    Active - Recruiting

  • Northridge Clinical Trials

    Northridge 5377985, California 5332921 91325
    United States

    Active - Recruiting

  • NorCal Clinical Research

    Rocklin 5388319, California 5332921 95765
    United States

    Active - Recruiting

  • Florida Academic Dermatology Center

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Florida Academic Dermatology Center

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Active - Recruiting

  • Georgia Skin & Cancer Clinic

    Savannah, Georgia 31419
    United States

    Site Not Available

  • Georgia Skin & Cancer Clinic

    Savannah 4221552, Georgia 4197000 31419
    United States

    Active - Recruiting

  • The Indiana Clinical Trials Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Indiana University School of Medicine

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • The Indiana Clinical Trials Center

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Active - Recruiting

  • Equity Medical LLC (Kentucky)

    Bowling Green, Kentucky 42104
    United States

    Site Not Available

  • DS Research of Kentucky, LLC

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Equity Medical LLC (Kentucky)

    Bowling Green 4285268, Kentucky 6254925 42104
    United States

    Active - Recruiting

  • DS Research of Kentucky, LLC

    Louisville 4299276, Kentucky 6254925 40241
    United States

    Active - Recruiting

  • DelRicht LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • DelRicht LLC

    Baton Rouge 4315588, Louisiana 4331987 70809
    United States

    Active - Recruiting

  • Clinical Trials Management, LLC

    Metairie 4333177, Louisiana 4331987 70006
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • MediSearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • MediSearch Clinical Trials

    Saint Joseph 4407010, Missouri 4398678 64506
    United States

    Active - Recruiting

  • Skin Cancer and Dermatology Institute

    Sparks, Nevada 89436
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute

    Reno 5511077, Nevada 5509151 89509
    United States

    Active - Recruiting

  • Skin Cancer and Dermatology Institute

    Sparks 5512862, Nevada 5509151 89436
    United States

    Site Not Available

  • Equity Medical

    New York, New York 10023
    United States

    Site Not Available

  • Equity Medical

    New York 5128581, New York 5128638 10023
    United States

    Active - Recruiting

  • OptiSkin Medical

    New York 5128581, New York 5128638 10128
    United States

    Active - Recruiting

  • Optima Research

    Boardman, Ohio 44512
    United States

    Site Not Available

  • ClinOhio Research Services

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Apex Clinical Research Center

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Optima Research

    Boardman 5147784, Ohio 5165418 44512
    United States

    Active - Recruiting

  • ClinOhio Research Services

    Columbus 4509177, Ohio 5165418 43213
    United States

    Active - Recruiting

  • Apex Clinical Research Center

    Mayfield Heights 5162188, Ohio 5165418 44124
    United States

    Active - Recruiting

  • Best Skin Research LLC

    Camp Hill 5182928, Pennsylvania 6254927 17011
    United States

    Active - Recruiting

  • Palmetto Clinical Trial Services

    Anderson, South Carolina 29625
    United States

    Site Not Available

  • DelRicht Research

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Palmetto Clinical Trial Services

    Anderson 4569298, South Carolina 4597040 29625
    United States

    Active - Recruiting

  • DelRicht Research

    Mt. Pleasant 4588165, South Carolina 4597040 29464
    United States

    Active - Recruiting

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • International Clinical Research - Tennessee LLC

    Murfreesboro 4644312, Tennessee 4662168 37130
    United States

    Active - Recruiting

  • BRCR Global Texas

    Katy, Texas 77450
    United States

    Site Not Available

  • DelRicht Research

    Prosper, Texas 75078
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • BRCR Global Texas

    Katy 4702732, Texas 4736286 77450
    United States

    Active - Recruiting

  • DelRicht Research

    Prosper 4720833, Texas 4736286 75078
    United States

    Active - Recruiting

  • Progressive Clinical Research

    San Antonio 4726206, Texas 4736286 78213
    United States

    Active - Recruiting

  • Dermatology Specialists of Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

  • Frontier Dermatology

    Mill Creek 5803457, Washington 5815135 98012
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle 5809844, Washington 5815135 98164
    United States

    Active - Recruiting

  • Dermatology Specialists of Spokane

    Spokane 5811696, Washington 5815135 99202
    United States

    Active - Recruiting

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