Phase II randomized double-blind placebo-controlled study of HE009 tablets in moderate-to-severe active systemic lupus erythematosus

Phase 2, randomised, double-blind trial in systemic lupus erythematosus (SLE) comparing HE009 plus stable standard therapy with Placebo plus stable standard therapy (2 arms). Primary endpoints: Incidence and severity of adverse events, serious adverse events, and abnormal safety assessments, Pharmacokinetic characteristics of HE009 and 1 more. Started Nov 2025; status: active.