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Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
NCT06843239 · View on ClinicalTrials.gov ↗
Study 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)
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Tibulizumab
Study Locations (20)
Other
- 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
California
- UCSD Altman Clinical and Translational Research Institute Center for Clinical Research — La Jolla
Florida
- IRIS Research and Development LLC — Plantation
Iowa
- University of Iowa — Iowa City
Massachusetts
- Massachusetts General Hospital — Boston
Michigan
- University of Michigan Hospital — Ann Arbor
Texas
- Rheumatology Associates — Arlington
Buenos Aires
- STAT Research S.A. — Buenos Aires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06843239
The ClinicalTrials.gov registry entry for NCT06843239 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zura Bio, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Scleroderma appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06843239 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06843239 about?
NCT06843239 is a clinical study titled "Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)". 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 an...
What is the current status of trial NCT06843239?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2025-02-06. Estimated completion is 2028-01.
What conditions does trial NCT06843239 study?
This clinical trial studies the following conditions: Scleroderma, Systemic Sclerosis (SSc). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06843239?
The interventions under investigation include: Placebo (OTHER), Tibulizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06843239?
This trial is sponsored by Zura Bio, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06843239 being conducted?
This trial has 20 study locations across California, Florida, Iowa, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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