RecruitingPhase 2NCT06843239

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis

Sponsor

Zura Bio Inc

Enrollment

80 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

Scleroderma Systemic Sclerosis (SSc)

Summary

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called tibulizumab in people with systemic sclerosis (also called scleroderma), a serious autoimmune disease that causes the immune system to attack connective tissue, leading to skin hardening, organ damage, and other complications. **You may be eligible if...** - You are between 18 and 75 years old with a BMI between 18 and 38 - You have been diagnosed with diffuse cutaneous systemic sclerosis (a form with widespread skin involvement) - Your first non-Raynaud's symptom appeared within the last 7 years - Your skin involvement score is between 15 and 45 (on a standard medical scale) **You may NOT be eligible if...** - You have another serious autoimmune condition - You have severe organ complications (e.g., severe lung or kidney disease) - You are on certain immune-suppressing medications that conflict with the trial drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTibulizumab

Anti BAFF/IL-17 antibody

OTHERPlacebo

Placebo (inactive)

Locations(51)

UCSD Altman Clinical and Translational Research Institute Center for Clinical Research

La Jolla, California, United States

IRIS Research and Development LLC

Plantation, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Rheumatology Associates

Arlington, Texas, United States

STAT Research S.A.

Buenos Aires, Buenos Aires, Argentina

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, Tucumán Province, Argentina

Organización Médica de Investigación

Buenos Aires, Argentina

Centro de Investigación y Prevención Cardiovascular-Arenales

Buenos Aires, Argentina

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, Argentina

Instituto de Investigación Clínica TyT

Buenos Aires, Argentina

Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)

Buenos Aires, Argentina

Consultorios Médicos Dr. Doreski

Buenos Aires, Argentina

Consultora Integral de Salud Centro Médico Privado

Córdoba, Argentina

Instituto CER S.A.

Quilmes, Argentina

AES - AS - Clinica Mayo de Urgencias

San Miguel de Tucumán, Argentina

CTR Estudios Clinicos

Santiago, Chile

Enroll SpA

Santiago, Chile

Centro de especialidades médicas Vanguardia

Temuco, Chile

Clinical Research Chile SpA

Valdivia, Chile

Centro de Estudios Clinicos Victoria Limitada (Cevic)

Victoria, Chile

Dermacross Clinica Dermatologica

Vitacura, Chile

Pécsi Tudomanyegyetem - Vasvari Pal u.

Pécs, Hungary

Mediadvance Clinical

Chihuahua City, Mexico

PanAmerican Clinical Research

Guadalajara, Mexico

Medical Care and Research S.A. de C.V.

Mérida, Mexico

Centro de Investigación y Tratamiento Reumatológico S.C

Miguel Hidalgo, Mexico

Oaxaca Site Management Organization - Clinic - OSMO - PPDS

Oaxaca City, Mexico

M2M Med-ul.

Chorzów, Poland

Malopolskie Badania Kliniczne Sp. z o.o.

Krakow, Poland

Malopolskie Centrum Kliniczne

Krakow, Poland

Centrum Medyczne Plejady

Krakow, Poland

Twoja Przychodnia PCM - ul.

Poznan, Poland

Klinika Reuma Park sp . zoo Sp.k.

Warsaw, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Poland

Center for Clinical and Basic Research (CCBR)

Bucharest, Romania

Sf.Maria Clinical Hospital

Bucharest, Romania

Hiperdia Romania

Bucharest, Romania

Institute of Rheumatology - PPDS

Belgrade, Serbia

Military Medical Academy

Belgrade, Serbia

Hospital de La Santa Creu i Sant Pau

Barcelona, Spain

Corporacio Sanitaria Parc Tauli

Barcelona, Spain

Hospital Quironsalud Infanta Luisa

Seville, Spain

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Royal National Hospital for Rheumatic Diseases

Bath, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

Chapel Allerton Hospital

Leeds, United Kingdom

Aintree University Hospital

Liverpool, United Kingdom

Royal Free Hospital

London, United Kingdom

Haywood Community Hospital

Stoke-on-Trent, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06843239

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