Platform Clinical Study for Conquering Scleroderma

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/EuropeanLeague Against Rheumatism criteria. Participants with diffuse, limited or sinecutaneous skin involvement are eligible

3. Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to theScreening 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 ofrandomization)

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 morepredicted normal, corrected for hemoglobin;

Other protocol and/or subprotocol inclusion criteria apply.

Exclusion Criteria:

1. Presence of clinically significant pulmonary abnormalities inconsistent with ILD onHRCT (e.g., scarring due to previous active tuberculosis [TB], sarcoidosis, lungmass, or other findings unrelated to SSc-ILD, as determined by a localradiologist/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 ScreeningVisit

5. History of stem cell transplantation, bone marrow transplantation, chimeric antigenreceptor T-cell therapy, or solid organ transplantation;

6. History of treatment with rituximab within the 6 months prior to the ScreeningVisit;

7. History treatment with cell-depleting therapies other than rituximab, including, butnot 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 orcyclophosphamide 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 theChronic 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 internationalnormalized 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 theInvestigator, could contraindicate the administration of study product, affectcompliance, interfere with study evaluations, or confound the interpretation ofstudy results

12. Presence of a concomitant life-threatening disease with life expectancy <12 monthsbased 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.