NCT05407246

Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study on the Efficacy and Safety of hemay005 Tablets in the Treatment of Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study. The study was divided into three stages, including screening period, treatment period and observation period. All subjects need to enter a 28 day (4-week) observation period after stopping hemay005 treatment. Screening period: all subjects shall have a screening period of no more than 28 days (4 weeks) before the baseline visit (day 1 of randomization). Treatment period: after screening and meeting the inclusion requirements of the study, as subjects were randomly divided into hemay005 60 mg twice daily (bid) dose group (group A), 75 mg bid dose group (group B) and placebo control group (Group C) according to the ratio of 1:1:1. A total of 90 subjects were included in the three groups. They were titrated in the first 6 days. From the 7th day, the subjects received fixed dose administration twice a day for 112 consecutive days (16 weeks). Considering the difference in the proportion of men and women with as, and the slow onset and mild condition of women, randomization will minimize the imbalance between treatment groups according to gender stratification. Observation period: Subjects in the study (including those who withdrew from the treatment early for any reason) shall be observed for 4 weeks after the end of the last administration. 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.

Conditions

• Active Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Hemay005	Hemay005 60 mg treatment group (group A): hemay005 tablets 60 mg bid were used during the treatment period; Hemay005 75 mg treatment group (group B): hemay005 75 mg bid was used during the treatment period; Placebo group (Group C): placebo (hemay005 tablet simulant) bid was used during the treatment period;

Timeline

• Start date: 2022-08-05
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2022-06-07
• Last updated: 2024-01-11

Locations

11 sites across 1 country: China