Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Prior treatment

• 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

Other illness

• 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

• 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)