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
UCSD Altman Clinical and Translational Research Institute Center for Clinical Research
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92037
IRIS Research and Development LLC
Plantation 4168782, Florida 4155751 33324
Plantation 4168782, Florida 4155751 33324
University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
University of Michigan Hospital
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Rheumatology Associates
Arlington 4671240, Texas 4736286 76012
Arlington 4671240, Texas 4736286 76012
More Details
- NCT ID
- NCT06843239
- Status
- Recruiting
- Sponsor
- Zura Bio Inc