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RECRUITING
NCT07237568
PHASE3

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

Sponsor: Lynk Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2025-08-29

Completion Date

2027-09

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

DRUG

LNK01001

Capsule; Oral

DRUG

Placebo

Capsule; Oral

Locations (1)

Peking Union Medical College Hospital

Beijing, China