NCT07237568

A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: Lynk Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of LNK01001 in subjects with active ankylosing spondylitis. The study is comprised of a 16-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 36-week open-label, long-term extension period (the Open-Label Extension Period). In the Double-Blind Period, participants will be randomized in a 1:1 ratio to receive either LNK01001 or placebo twice daily (BID). Participants in the placebo group will be switched to LNK01001 BID at Week 16 in the Open-Label Extension Period.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	LNK01001	Capsule; Oral
DRUG	Placebo	Capsule; Oral

Timeline

• Start date: 2025-08-29
• Primary completion: 2026-11-01
• Completion: 2027-09-01
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: China