Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Purpose
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
- Systemic Sclerosis (SSc)
- Scleroderma
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tibulizumab |
Subcutaneous injection |
|
|
Placebo Comparator Placebo |
Subcutaneous injection |
|
Recruiting Locations
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Zura Bio Inc