Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion 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;
Other protocol and/or subprotocol inclusion criteria apply.
Exclusion Criteria:
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;
Other protocol and/or subprotocol exclusion criteria apply.
