Phase 3 Study of Hemay005 Tablets for Treating Behets Disease in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the efficacy and safety of Hemay005 tablets in patients with Behets disease through a phase 3, multi-center, randomized, placebo-controlled, double-blind study. The trial compares high and low doses of Hemay005 against placebo to better understand treatment effects in this condition. The study includes adults aged 18 to 75 years diagnosed with Behets disease and experiencing oral ulcers. Participants are randomly assigned to one of three groups Hemay005 60 mg twice daily, Hemay005 45 mg twice daily, or placebo, during a 12-week core treatment phase. After this, all participants enter a 40-week extension phase where those initially receiving placebo are re-randomized to one of the two Hemay005 doses. Dose escalation occurs during the first week of treatment periods to reduce side effects. Following treatment, a 4-week observation period monitors drug discontinuation effects. Throughout the study, participants undergo regular assessments including oral and genital ulcer evaluations, pain scales, joint and skin lesion assessments, gastrointestinal activity monitoring, eye symptom checks, quality of life questionnaires, and laboratory tests. Safety is closely monitored by tracking adverse events and lab results over the course of treatment and follow-up. The primary outcome focuses on the efficacy related to oral ulcers at week 12, with continued efficacy and safety evaluations throughout the study duration.

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease