This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.
have had a detailed understanding of the nature, significance, potential benefits, potential risks, and procedures of the study, and voluntarily signed a written Informed Consent Form (ICF).
Males or females aged≥18 and ≤75 years.
Have a clinical diagnosis of SLE 6 months prior to signing the ICF, meeting at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
SLEDAI-2K≥8 at screening.
Pregnant or lactating women, and men or women who have birth plans in the past 12 months.
Have neuropsychiatric systemic lupus erythematosus (NPSLE) within 6 months prior to the first dose, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cranial neuropathy, cerebritis, cerebral vasculitis or lupus headache.
Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.
Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).
Parallel
Orelabrutinib (Low Dose)
DrugSubjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy
Orelabrutinib (High Dose)
DrugSubjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy
Orelabrutinib Placebo
DrugSubjects will be administered with Orelabrutinib Placebo orally once daily in combination with SOC therapy
SLE Responder Index (SRI) - 4 response rate
SRI-4 response is defined as: 1)≥4 point reduction from baseline in SLE disease activity index-2000 (SLEDAI-2K) score; 2) no worsening (increase of \<0.3 points from baseline) in Physician's Global Assessment (PGA); 3) no new A organ domain score or no more than 1 new B organ domain scores compared with baseline in British Isles Lupus Assessment Group (BILAG)-2004.
SLE Responder Index (SRI) - 6 response rate
SRI-6 response is defined as: 1)≥6 point reduction from baseline in SLE disease activity index-2000 (SLEDAI-2K) score; 2) no worsening (increase of \<0.3 points from baseline) in Physician's Global Assessment (PGA); 3) no new A organ domain score or no more than 1 new B organ domain scores compared with baseline in British Isles Lupus Assessment Group (BILAG)-2004.
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rate
BICLA response is defined as: 1) In BILAG-2004, reduction of all baseline A to B/C/D and baseline B to C/D, and no worsening in other organ systems (as defined by no new A organ domain score or no more than 1 new B organ domain scores); 2) No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of \>0 points in SLEDAI-2K; 3) No worsening (increase of \<0.3 points from baseline) in PGA.
Time to 1st flare
The proportion of subjects whose average prednisone dose has been reduced by≥25% from baseline to ≤7.5 mg/day
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