Phase II Study of D-2570 to Treat Adults With Active Systemic Lupus Erythematosus Aged 18 to 70

What this Trial Is About

Researchers are studying the effects of D-2570 in adults with active systemic lupus erythematosus SLE through a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. The goal is to evaluate the efficacy and safety of D-2570 in treating this condition, which requires participants to have active disease and meet specific clinical criteria. This study is sponsored by InventisBio Co., Ltd and aims to better understand treatment options for patients with active SLE. Participants who join will go through a screening period to confirm eligibility based on detailed inclusion and exclusion criteria. Eligible participants are then randomly assigned to one of four groups three groups receiving different doses or combinations of D-2570 and a placebo, or a placebo-only group. During the 48-week treatment period, participants will take the assigned investigational product daily while both participants and researchers remain unaware of group assignments. Blood samples for pharmacokinetic and pharmacodynamic analyses will be collected at scheduled times throughout the study. After treatment, a safety follow-up period will occur. Throughout the trial, participants will have regular evaluations including clinical assessments, blood tests, and disease activity measurements such as the Systemic Lupus Erythematosus Responder Index and Disease Activity Index. Researchers will monitor changes in joint counts, skin involvement, antibody levels, and complement proteins to assess response to treatment. Safety will be tracked by recording adverse events and laboratory results over approximately 52 weeks. This comprehensive monitoring helps evaluate both treatment effects and participant safety during and after the study.

A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE)