To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
CM313 600mg(4ml)/vial. Subcutaneous injection 600mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
CM313 600mg(4ml)/vial. Subcutaneous injection 1200mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
Placebo 4 mL/vial. Subcutaneous injection 4 or 8 mL. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline
Time frame: Up to week 24
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