🏛️ Verified NIH Record • Updated 2026-07-17

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) (NCT06843239)

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

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Zura Bio Inc

🩺 Plain-English Summary (8th-Grade Level)

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)

Who can join: Review the eligibility criteria below.

Location: UCSD Altman Clinical and Translational Research Institute Center for Clinical Research — La Jolla, California

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (60 Sites)

Showing the first 25 of 60 sites.

  • UCSD Altman Clinical and Translational Research Institute Center for Clinical Research — La Jolla, California
  • UCLA Department of Medicine — Los Angeles, California
  • IRIS Research and Development LLC — Plantation, Florida
  • University of Iowa — Iowa City, Iowa
  • Massachusetts General Hospital — Boston, Massachusetts
  • University of Michigan Hospital — Ann Arbor, Michigan
  • Rheumatology Associates — Arlington, Texas
  • STAT Research S.A. — Buenos Aires, Buenos Aires
  • Centro de Investigaciones Médicas Tucumán — San Miguel de Tucumán, Tucumán Province
  • Organización Médica de Investigación — Buenos Aires,
  • Centro de Investigación y Prevención Cardiovascular-Arenales — Buenos Aires,
  • Hospital General de Agudos Dr. José María Ramos Mejia — Buenos Aires,
  • Instituto de Investigación Clínica TyT — Buenos Aires,
  • Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF) — Buenos Aires,
  • Consultorios Médicos Dr. Doreski — Buenos Aires,
  • Consultora Integral de Salud Centro Médico Privado — Córdoba,
  • Instituto CER S.A. — Quilmes,
  • AES - AS - Clinica Mayo de Urgencias — San Miguel de Tucumán,
  • CTR Estudios Clinicos — Santiago,
  • Enroll SpA — Santiago,
  • Centro de especialidades médicas Vanguardia — Temuco,
  • Clinical Research Chile SpA — Valdivia,
  • Centro de Estudios Clinicos Victoria Limitada (Cevic) — Victoria,
  • Dermacross Clinica Dermatologica — Vitacura,
  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus — Debrecen,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗