Platform Clinical Study for Conquering Scleroderma

Eligibility Criteria

• 1. Male or female 18+ years of age at the time of signed informed consent;
• 2. SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. An enrollment cap will apply to the limited/sine cutaneous SSc subtype. The enrollment cap will allow for equal or less than 30% of limited/sine cutaneous SSc subtype study participants for each Regimen-specific Subprotocol (IP);
• 3. Onset of SSc (defined by first non-Raynaud's symptom) 5 years or less prior to the Screening Visit;
• 4. Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc;
• 5. Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
• 6. Presence of an FVC 45% or more predicted normal;
• 7. Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin;
• 1. Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis \[TB\], sarcoidosis, lung mass, or otherfindings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);
• 2. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
• 3. Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study;
• 4. History of Child-Pugh Class B or Class C liver disease;
• 5. Presence of any of the following laboratory findings at the Screening Visit:
• * Estimated glomerular filtration rate \<45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
• * Alanine aminotransferase or aspartate aminotransferase level \>1.5 × upper limit of normal (ULN);
• * Platelets \<100 × 109/L (100,000/μL);
• * White blood cell count \<2500/μL;
• * Neutrophil blood count \<1500/μL;
• * Prolongation of prothrombin time and partial thromboplastin time \>1.5 × ULN, or international normalized ratio \>2; or
• * Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study.
• 6. History of major trauma or hemorrhage within 30 days of the Screening Visit;
• 7. History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit;
• 8. Presence of other clinically significant risk of bleeding events, including coagulation or platelet disorders, at the Screening Visit as determined by the Investigator;
• 9. History of any cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of the Screening Visit;
• 10. History of myocardial infarction or unstable angina within 6 months of the Screening Visit, or plans to undergo a coronary procedure during participation in the study;
• 11. Presence of acute or chronic congestive heart failure (New York Heart Association Class III \[moderate\] or Class IV \[severe\]) at the Screening Visit;