Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06843239 · ClinicalTrials.gov registry record · Phase 2
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
A Phase 2 study of Scleroderma and Systemic Sclerosis (SSc), sponsored by Zura Bio.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT06843239: Recruiting Phase 2 study of Scleroderma and Systemic Sclerosis (SSc), sponsored by Zura Bio.
NCT06843239 is a Phase 2 study of Scleroderma and Systemic Sclerosis (SSc) that is actively recruiting participants, run by Zura Bio. The registered enrollment target is 80 participants, below the 399-participant average among 23 other Scleroderma trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06843239, a Phase 2 study of Scleroderma and Systemic Sclerosis (SSc), is actively recruiting participants, sponsored by Zura Bio.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)
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 |
What NCT06843239 shows while recruiting
NCT06843239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 399-participant average among 23 other Scleroderma trials with a reported enrollment target (80% lower).
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.
NCT06843239 names 20 study sites across 9 states, led by Other, California, Florida.
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).
What interventions are being tested in trial NCT06843239?
The interventions under investigation include: Placebo (OTHER), Tibulizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06843239?
This trial is sponsored by Zura Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Scleroderma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06843239's enrollment target sits among peer trials
80 12th of 23 higher than 11 of 23 other Scleroderma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Scleroderma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Platform Clinical Study for Conquering Scleroderma
RECRUITING · Phase 2
-
AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.
RECRUITING · Phase 2
-
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
RECRUITING · Phase 2
-
Psychological Treatments for Scleroderma
COMPLETED · Phase 2
-
Rheumatology Diet Study
RECRUITING
-
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI