drugset / Trial / NCT07237568
A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-08-29
- Primary completion
- 2026-11
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zemprocitinib | Small molecule | 12 mg | Oral |