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

Sponsor
Lynk Pharmaceuticals Co., Ltd
Study ID
NCT07237568
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LNK01001 — DRUG
    Capsule; Oral
  • Placebo — DRUG
    Capsule; Oral

Study Details

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.

Key Dates

Start date
Aug 29, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
352 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LNK01001 12mg
    Participants receive LNK01001 12mg orally BID for 52 weeks.
  • Placebo Comparator: Placebo
    Participants receive matching placebo for 16 weeks and then switch to receive LNK01001 12mg orally BID for 36 weeks.

Primary Outcome Measure

Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 16 [ Time Frame: Baseline and week 16 ]

Central Contacts

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