Phase II Study of TQH3906 Capsules for Treating Systemic Lupus Erythematosus Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

What this Trial Is About

Researchers are evaluating the efficacy and safety of TQH3906, a Tyrosine Kinase 2 TYK2 inhibitor, in treating systemic lupus erythematosus SLE, an autoimmune disease. This randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial aims to assess how well TQH3906 works and its safety profile in adults diagnosed with SLE based on established criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of three groups 16 mg TQH3906 capsule, 24 mg TQH3906 capsule, or placebo. All treatments are taken orally once daily for 48 weeks. The trial compares these doses to placebo to understand TQH3906s impact on disease activity. The study uses a parallel design and includes a quadruple masking method to keep participants and researchers unaware of group assignments. During the study, participants undergo regular assessments including clinical evaluation of disease activity using the Systemic Lupus Erythematosus Responder Index 4 SRI-4, lupus activity indices, and joint assessments up to week 48. Safety is monitored throughout, and background lupus medications must remain stable during the trial. The primary outcome measure is the percentage of participants achieving SRI-4 response by week 32, with additional secondary measures assessing remission, low disease activity, and symptom improvements. Participation lasts up to 48 weeks with scheduled visits and monitoring.

A Clinical Trial on the Efficacy and Safety of TQH3906 in the Treatment of Systemic Lupus Erythematosus