Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
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
Zura Bio Inc
80 participants
Feb 6, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria10
- 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
Interventions
Placebo (inactive)
Anti BAFF/IL-17 antibody
Locations(51)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06843239