Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

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)