Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study. The study was divided into three stages, including screening period(4-week), treatment period(16-week) and observation period. All subjects need to enter a 28 day (4-week) observation period after stopping hemay005 treatment. Main purpose: The efficacy of hemay005 tablet in the treatment of active ankylosing spondylitis (as) was evaluated by placebo parallel control. Secondary purpose: * To evaluate the safety of oral hemay005 tablets in patients with active as. * To evaluate the population pharmacokinetics of hemay005 tablets in patients with active as.

Timeline

Start

2022-08-05

Primary completion

2023-08-18

Completion

2023-08-18

Drugs

Indications