A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
Recruiting
Phase 3
Interventional Study
Ankylosing Spondylitis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 352 (estimated)
- Sponsor
- Lynk Pharmaceuticals Co., Ltd · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS.
* Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits and Must have a Total Back Pain sc…
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