Platform Clinical Study for Conquering Scleroderma

Exclusion criteria

• . 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);
• . Presence of infected ulcers or active gangrene at the Screening Visit;
• . History of scleroderma renal crisis within 6 months prior to the Screening Visit;
• . Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit
• . History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
• . History of treatment with rituximab within the 6 months prior to the Screening Visit;
• . 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
• . Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit