Phase IIb Study to Test Safety and Effectiveness of Orelabrutinib with Standard Care in Adults with Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating the efficacy and safety of orelabrutinib in adults with systemic lupus erythematosus SLE who are already receiving standard care treatments. This phase IIb study is randomized, double-blind, placebo-controlled, and conducted at multiple centers to better understand how well orelabrutinib works and how safe it is for this population. Participants are assigned to one of three groups receiving either a low dose of orelabrutinib, a high dose of orelabrutinib, or a placebo. All treatments are taken orally once daily alongside standard of care therapy. The study lasts 48 weeks, with assessments continuing up to 52 weeks to monitor safety and treatment responses. During the trial, participants will have regular evaluations measuring their response to treatment using tools like the SLE Responder Index and assessments of lupus flare timing. Researchers will also track changes in health surveys, antibody levels, and medication use. Safety is closely monitored through reports of adverse events, with the full study duration extending slightly beyond the treatment period for follow-up.

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus