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. Participants with diffuse, limited or sine
cutaneous skin involvement are eligible
3. Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the
Screening Visit;
4. A Modified Rodnan skin score (mRSS) less than 40
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 other findings unrelated to SSc-ILD, as determined by a local
radiologist/Investigator);
2. Presence of infected ulcers or active gangrene at the Screening Visit;
3. History of scleroderma renal crisis within 6 months prior to the Screening Visit;
4. Forced expiratory volume in 1 second/FVC <0.65 (pre-bronchodilator) at the Screening
Visit
5. History of stem cell transplantation, bone marrow transplantation, chimeric antigen
receptor T-cell therapy, or solid organ transplantation;
6. History of treatment with rituximab within the 6 months prior to the Screening
Visit;
7. History treatment with cell-depleting therapies other than rituximab, including, but
not limited to, CAMPATH®; anti-cluster of differentiation (CD)3, anti-CD4, anti-CD5,
antiCD19, and anti-CD20 agents; and investigational agents
8. Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide,
tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or
cyclophosphamide within 6 months prior to Screening Visit
9. History of use of any investigational medication or device for any indication within
30 days or 5 half-lives (whichever is longer) prior to Screening Visit.
10. 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 > (2 x ULN);
- Platelets <100 × 109/L (100,000/μL);
- White blood cell count <2500/μL;
- Neutrophil blood count <1500/μL;
- 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.
11. Presence of a clinically significant disorder that, in the opinion of the
Investigator, could contraindicate the administration of study product, affect
compliance, interfere with study evaluations, or confound the interpretation of
study results
12. Presence of a concomitant life-threatening disease with life expectancy <12 months
based on the Investigator's assessment;
13. Evidence of active tuberculosis (TB) or being at high risk for TB
Other protocol and/or subprotocol exclusion criteria apply.