A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

RC18G002

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

2024-07-01

2027-03-01

2027-04-01

Not yet recruiting

Early phase I

350

Inclusion Criteria: 1. Age 12-70 years at screening. 2. Has a diagnosis of SLE for at least 6 months prior to the screening visit. 3. Meets the 2019 EULAR/ACR Classification criteria for SLE. 4. Moderately to severely active SLE definined by the following: 1. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening; 2. BILAG organ system scores of at least 1A or 2B at screening. 5. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization. 6. At least one positive serologic parameter within the screening period. 7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent. Exclusion Criteria: 1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening. 2. Active or unstable neuropsychiatric SLE. 3. Autoimmune or rheumatic disease other than SLE. 4. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening. 5. History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

2024-06-13