NCT05861102

Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).

Detailed description

Approximately 258 eligible subjects (129 per arm) will be randomized in a 1:1 ratio to Jaktinib 100mg BID (twice daily) or matching placebo BID for a total of 16 weeks of blinded treatment. During the 16-week treatment period subjects will visit the clinic every two weeks until the Week 4 visit and then every 4 weeks until the completion of Week 16.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Jaktinib	Participants will receive 100 mg Jaktinib orally twice daily for 16 weeks
DRUG	Placebo	Participants will receive matching placebo orally twice daily for 16 weeks

Timeline

• Start date: 2023-07-20
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2023-05-16
• Last updated: 2026-01-05

Locations

1 site across 1 country: China