Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Systemic Sclerosis (SSc), Scleroderma
In brief
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)
Key facts
- Study ID
- NCT06843239
- Run by
- Zura Bio Inc
- People needed
- 80
- Starts
- 2025-02-06
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, 18 to 75 years of age
- Body mass index between 18.0 and 38.0 kg/m²
- Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
- Has diffuse cutaneous SSc, defined as mRSS >0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis
- Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years
- mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive
- FVC >50% predicted
- Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)
You may not qualify if…
- Has any of the following complications:
- Left ventricular failure
- Pulmonary arterial hypertension
- Renal crisis within previous 6 months
- Gastrointestinal dysmotility within previous 3 months
- Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months
- Current rheumatic disease other than SSc that could interfere with assessment of SSc
- Lung disease requiring continuous oxygen therapy
- Evidence or suspicion of active or latent tuberculosis
- Active Crohn's Disease or ulcerative colitis
Where it is running
- UCLA Department of Medicine — Los Angeles, 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
- Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus — Debrecen, Hungary
- UCSD Altman Clinical and Translational Research Institute Center for Clinical Research — La Jolla, California, United States
Full record on ClinicalTrials.gov
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