A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Systemic Lupus Erythematosus
This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and a 12-week safety follow-up period. Approximately 245 SLE patients will be included.
• Male and female participants aged 18 through 65 years (including boundary value)at the time of screening.
• The Body Mass Index (BMI) ≥18 kg/m ² at the time of screening.
• Diagnosed with SLE for at least 6 months prior to screening.
• ANA≥1:80, or anti-dsDNA antibodies and/or anti-Sm antibodies above the upper limit of the normal range as determined by a central laboratory at the time of screening.
• High disease activity at screening and at baseline.
• Currently receiving at least one or more of the following standard therapies for SLE at stable doses: oral corticosteroids (OCS), antimalarial drugs, and conventional immunosuppressants.
• Participants thoroughly understand the content, process and possible adverse reactions before the trial, and voluntarily sign the written informed Consent Form (ICF).
• Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol.