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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
The absolute change from baseline in Forced Vital Capacity (FVC) in mL
Time frame: At 12 months
The absolute change from baseline in Modified Rodnan Skin Score (mRSS)
Time frame: At month 12
The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score
Time frame: Up to month 36
Time to progression, defined as the time from randomization to progressive disease
Time frame: Approximately 54 months
The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue
Time frame: Up to month 36
The change from baseline in Scleroderma Clinical Index (ScleroID)
Time frame: Up to month 36
The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI)
Time frame: Up to month 36
The change from baseline in PROMIS-29
Time frame: Up to month 36
The change from baseline in St. George's Respiratory Questionnaire (SGRQ)
Time frame: Up to month 36
The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale
Time frame: Up to month 36
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0035
Scottsdale, Arizona, United States
Local Institution - 0092
Aurora, Colorado, United States
Local Institution - 0001
Denver, Colorado, United States
Local Institution - 0069
Miami, Florida, United States
Local Institution - 0014
Atlanta, Georgia, United States
Local Institution - 0139
Chicago, Illinois, United States
Local Institution - 0084
Worcester, Massachusetts, United States
Local Institution - 0034
Ann Arbor, Michigan, United States
Local Institution - 0037
Rochester, Minnesota, United States
Local Institution - 0082
Summit, New Jersey, United States
...and 44 more locations
The change from baseline in EQ-5D-5L Utility Index
Time frame: Up to month 36
The absolute change from baseline in FVC in mL
Time frame: Up to month 36
The absolute change from baseline in FVC in mL/year
Time frame: Up to month 36
The absolute change from baseline in Percent Predicted Forced Vital Capacity (ppFVC)
Time frame: Up to month 36
The relative change from baseline in ppFVC
Time frame: Up to month 36
The absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: Up to month 36