About this trial
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
Eligibility criteria
Qualifiers
None
Disqualifiers
Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening.
Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment
Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening.
Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).
Trial design
Treatments tested in this trial
- BMS-986353
- Fludarabine
- Cyclophosphamide
- Tocilizumab
- Rituximab
- Nintedanib
Treatment groups
Sponsors and collaborators
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lead sponsor
Celgene Corporation
Collaborator