NCT06843239 Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
| NCT ID | NCT06843239 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zura Bio Inc |
| Condition | Systemic Sclerosis (SSc) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-02-06 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Study Director
STUDY DIRECTOR
Zura Bio Inc
Frequently Asked Questions
Who can join the NCT06843239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Systemic Sclerosis (SSc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06843239 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06843239 currently recruiting?
Yes, NCT06843239 is actively recruiting participants. Contact the research team at clinicaltrial@zurabio.com for enrollment information.
Where is the NCT06843239 trial being conducted?
This trial is being conducted at La Jolla, United States, Plantation, United States, Iowa City, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT06843239 clinical trial?
NCT06843239 is sponsored by Zura Bio Inc. The principal investigator is Study Director at Zura Bio Inc. The trial plans to enroll 80 participants.