Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

NCT ID: NCT06993610

Last Updated: 2025-11-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2027-03-31

Brief Summary

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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)

Detailed Description

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Conditions

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Hidradenitis Suppurativa (HS)

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tibulizumab Dose A

Subcutaneous injection

Group Type EXPERIMENTAL

Tibulizumab Dose A

Intervention Type BIOLOGICAL

Anti BAFF/IL-17 antibody. ZB-106

Tibulizumab Dose B

Subcutaneous injection

Group Type EXPERIMENTAL

Tibulizumab Dose B

Intervention Type BIOLOGICAL

Anti BAFF/IL-17 antibody. ZB-106

Placebo

Subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

ZB-106 Placebo

Interventions

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Tibulizumab Dose A

Anti BAFF/IL-17 antibody. ZB-106

Intervention Type BIOLOGICAL

Tibulizumab Dose B

Anti BAFF/IL-17 antibody. ZB-106

Intervention Type BIOLOGICAL

Placebo

ZB-106 Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zura Bio Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Dermatology Specialists (Phoenix)

Phoenix, Arizona, United States

Site Status RECRUITING

First OC Dermatology Research, Inc.

Irvine, California, United States

Site Status RECRUITING

Wallace Medical Group, Inc.

Los Angeles, California, United States

Site Status RECRUITING

NorCal Clinical Research

Rocklin, California, United States

Site Status RECRUITING

Florida Academic Dermatology Center

Coral Gables, Florida, United States

Site Status RECRUITING

Georgia Skin & Cancer Clinic

Savannah, Georgia, United States

Site Status RECRUITING

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status RECRUITING

Equity Medical LLC (Kentucky)

Bowling Green, Kentucky, United States

Site Status RECRUITING

DS Research of Kentucky, LLC

Louisville, Kentucky, United States

Site Status RECRUITING

DelRicht LLC

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Clinical Trials Management, LLC

Metairie, Louisiana, United States

Site Status RECRUITING

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status RECRUITING

Skin Cancer and Dermatology Institute

Sparks, Nevada, United States

Site Status RECRUITING

Equity Medical

New York, New York, United States

Site Status RECRUITING

Optima Research

Boardman, Ohio, United States

Site Status RECRUITING

ClinOhio Research Services

Columbus, Ohio, United States

Site Status RECRUITING

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Site Status RECRUITING

Palmetto Clinical Trial Services

Anderson, South Carolina, United States

Site Status RECRUITING

DelRicht Research

Mt. Pleasant, South Carolina, United States

Site Status RECRUITING

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, United States

Site Status RECRUITING

BRCR Global Texas

Katy, Texas, United States

Site Status RECRUITING

DelRicht Research

Prosper, Texas, United States

Site Status RECRUITING

Progressive Clinical Research

San Antonio, Texas, United States

Site Status RECRUITING

University of Washington Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Dermatology Specialists of Spokane

Spokane, Washington, United States

Site Status RECRUITING

Ryan Clinical Research Inc.

Newmarket, Ontario, Canada

Site Status RECRUITING

York Dermatology Clinic & Research Centre

Richmond Hill, Ontario, Canada

Site Status RECRUITING

Centre de recherche Saint-Louis

Québec, Quebec, Canada

Site Status RECRUITING

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

RENEW Clinic

Bialystok, , Poland

Site Status RECRUITING

Provita Sp. z o. o.

Katowice, , Poland

Site Status RECRUITING

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

Malbork, , Poland

Site Status RECRUITING

Laser Clinic S.C.

Szczecin, , Poland

Site Status RECRUITING

Edificio IMIBIC, Reina Sofia University Hospital

Córdoba, , Spain

Site Status RECRUITING

Gregorio Marañón General University Hospital

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status RECRUITING

Countries

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United States Canada Poland Spain

Central Contacts

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Chief Medical Officer

Role: CONTACT

Phone: 702-825-9872

Email: [email protected]

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