NCT04507659

Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis

A Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase Ⅱ Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites.

Detailed description

The study is divided into two stages, the first stage (1-16 weeks) is the main study; the second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Jaktinib Hydrochloride Tablets	Morning: 2\*50mg simulated tablets and 1\*75mg Jaktinib Hydrochloride Tablets; Evening: 2\*50mg simulated tablets and 1\*75mg Jaktinib Hydrochloride Tablets.
DRUG	Jaktinib Hydrochloride Tablets	Morning: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets; Evening: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets.
DRUG	Placebo	Morning: 1\*75mg simulated tablet, 2\*50mg simulated tablets; Evening: 1\*75mg simulated tablet, 2\*50mg simulated tablets.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2020-08-11
• Last updated: 2023-03-29

Locations

1 site across 1 country: China