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Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Sponsor: Zura Bio Inc
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)
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-02-06
Completion Date
2028-01
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Tibulizumab
Anti BAFF/IL-17 antibody
Placebo
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