Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

NCT06993610 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: ZB-106-HS-2022024-519736-17-00
• Study Type: interventional
• Target: 225
• Locations: 6 countries
• Sites: 61

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)

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis Suppurativa; HS; Tibulizumab; Hidradenitis Suppurativa clinical response; HiSCR; Skin Diseases; Inflammatory Skin Disease; Chronic Skin Condition; Sweat Gland Disease; Skin Diseases Bacterial; Suppurative Hidradenitis; Hidradenitis; Acne; Acne inversa; Inversa

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

Study Arms (3)

Tibulizumab Dose A

EXPERIMENTAL

Subcutaneous injection

Biological: Tibulizumab Dose A

Tibulizumab Dose B

EXPERIMENTAL

Subcutaneous injection

Biological: Tibulizumab Dose B

Placebo

PLACEBO COMPARATOR

Subcutaneous injection

Other: Placebo

Interventions

Tibulizumab Dose A BIOLOGICAL

Anti BAFF/IL-17 antibody. ZB-106

Tibulizumab Dose A

Tibulizumab Dose B BIOLOGICAL

Anti BAFF/IL-17 antibody. ZB-106

Tibulizumab Dose B

Placebo OTHER

ZB-106 Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Zura Bio Inc: lead

Study Sites (61)

Medical Dermatology Specialists (Phoenix)

Phoenix, Arizona, 85006, United States

Location

First OC Dermatology Research, Inc.

Irvine, California, 92614, United States

Location

Wallace Medical Group, Inc.

Los Angeles, California, 90056, United States

Location

Northridge Clinical Trials

Northridge, California, 91325, United States

Location

NorCal Clinical Research

Rocklin, California, 95765, United States

Location

Florida Academic Dermatology Center

Coral Gables, Florida, 33134, United States

Location

Skin Care Research, LLC

Hollywood, Florida, 33021, United States

Location

Georgia Skin & Cancer Clinic

Savannah, Georgia, 31419, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Equity Medical LLC (Kentucky)

Bowling Green, Kentucky, 42104, United States

Location

DS Research of Kentucky, LLC

Louisville, Kentucky, 40241, United States

Location

DelRicht LLC

Baton Rouge, Louisiana, 70809, United States

Location

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Skin Cancer and Dermatology Institute

Reno, Nevada, 89509, United States

Location

Equity Medical

New York, New York, 10023, United States

Location

OptiSkin Medical

New York, New York, 10128, United States

Location

Red River Research Partners

Fargo, North Dakota, 58103, United States

Location

Optima Research

Boardman, Ohio, 44512, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Best Skin Research LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Palmetto Clinical Trial Services

Anderson, South Carolina, 29625, United States

Location

DelRicht Research

Mt. Pleasant, South Carolina, 29464, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

BRCR Global Texas

Katy, Texas, 77450, United States

Location

DelRicht Research

Prosper, Texas, 75078, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Frontier Dermatology

Mill Creek, Washington, 98012, United States

Location

University of Washington Medical Center

Seattle, Washington, 98164, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Ryan Clinical Research Inc.

Newmarket, Ontario, L3Y 5G8, Canada

Location

North York Research Inc

North York, Ontario, M2J 5B2, Canada

Location

York Dermatology Clinic & Research Centre

Richmond Hill, Ontario, L4B 1L1, Canada

Location

Centre de recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, S7T 0G3, Canada

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Katholische Klinikum Bochum gGmbH

Bochum, 44791, Germany

Location

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

University Hospital Dresden

Dresden, 01307, Germany

Location

Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

Hamburg, 20251, Germany

Location

University Clinic Dermatology Heidelberg

Heidelberg, 69120, Germany

Location

Klinik und Poliklinik für Dermatologie und Allergologie

München, 80337, Germany

Location

University Hospital Muenster - Münster

Münster, 48149, Germany

Location

Semmelweis University

Budapest, 1085, Hungary

Location

University of Debrecen

Debrecen, 4032, Hungary

Location

University of Szeged

Szeged, 6720, Hungary

Location

RENEW Clinic

Bialystok, 15-797, Poland

Location

Provita Centrum Medyczne Sp. z o.o. Katowice

Katowice, 40-611, Poland

Location

Provita Sp. z o. o.

Katowice, 40-611, Poland

Location

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

Malbork, 82200, Poland

Location

SOLUMED

Poznan, 60-425, Poland

Location

Laser Clinic S.C.

Szczecin, 70-332, Poland

Location

Manufaktura Zdrowia i Urody

Warsaw, 02-922, Poland

Location

Edificio IMIBIC, Reina Sofia University Hospital

Córdoba, 14004, Spain

Location

Gregorio Marañón General University Hospital

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Skin Diseases; Dermatitis; Sweat Gland Diseases; Skin Diseases, Bacterial; Hidradenitis; Acne Vulgaris

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Acneiform Eruptions; Sebaceous Gland Diseases

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: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); ES (4); PL (7); US (34); DE (8); CA (5)