The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
513
Specified dose on specified days
Specified dose on specified days
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Time frame: At week 52
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Time frame: At week 52
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Time frame: At week 52
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
Time frame: At week 52
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Time frame: At week 52
Proportion of participants with oral corticosteroid (OCS) ≥ 7.5 mg/day of prednisone at baseline who are receiving ≤ 5 mg/day of prednisone at Week (Wk) 40 which is maintained through Wk52 and who achieve an SRI(4) response at Wk52
Time frame: At week 52
Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
Time frame: At week 52
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time frame: At week 52
Number of participants with adverse events (AEs)
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Local Institution - 0063
La Jolla, California, United States
Local Institution - 0241
La Mesa, California, United States
Local Institution - 0242
San Diego, California, United States
Local Institution - 0143
San Leandro, California, United States
Local Institution - 0147
Santa Monica, California, United States
Local Institution - 0213
Clearwater, Florida, United States
Local Institution - 0059
Jacksonville, Florida, United States
Local Institution - 0075
Margate, Florida, United States
Local Institution - 0007
Oakland Park, Florida, United States
Local Institution - 0239
Plant City, Florida, United States
...and 170 more locations
Time frame: Up to 156 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 156 weeks
Number of participants with AEs leading to discontinuation of treatment
Time frame: Up to 156 weeks
Number of participants with AEs leading to study discontinuation
Time frame: Up to 156 weeks
Number of participants with target adverse events of special interest (AESIs)
Time frame: Up to 156 weeks
Number of participants with laboratory abnormalities
Time frame: Up to 156 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 156 weeks
Number of participants with vital sign abnormalities
Time frame: Up to 156 weeks