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Breakfree-SSc: BMS-986353 vs Standard of Care in Active Systemic Sclerosis
NCT07335562Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2027
- Primary completion
- Nov 2028
- Countries
- 10
- Sponsor
- Bristol Myers Squibb
- Modality
- CAR-T Cells
- Drugs
- BMS-986353
- Conditions
- systemic sclerosis (SSc)
01
Overview
Phase 3, randomised, open-label trial in systemic sclerosis (SSc) comparing Arm A: BMS-986353 with Arm B: Standard of Care (2 arms). Primary endpoint: Forced Vital Capacity at 12 months. Planned start Feb 2027; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm A: BMS-986353
Experimental arm receiving BMS-986353 following lymphodepletion with Fludarabine and Cyclophosphamide.
Arm B: Standard of Care
Active comparator arm receiving standard of care (Tocilizumab, Rituximab, or Nintedanib).
03
Who it enrols
Participants must have active Systemic Sclerosis with Interstitial Lung Disease (>= 10% lung involvement) and positive ANA or anti-Scl-70 antibodies, and must have failed at least 6 months of prior immunomodulatory therapy. Excludes patients requiring supplemental oxygen, with severe PAH, or significant pulmonary/GI comorbidities.
04
Endpoints
Primary
Forced Vital Capacity
Secondary
Modified Rodnan Skin Score
Quantitative Interstitial Lung Disease-Whole Lung score
Time to progression
Patient-Reported Outcomes Measurement Information System-Fatigue
Scleroderma Clinical Index
Scleroderma Health Assessment Questionnaire - Disability Index
Patient-Reported Outcomes Measurement Information System-29
St. George's Respiratory Questionnaire
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