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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
* Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
Exclusion Criteria:
* Total spinal ankylosis.
* Participants with known allergies to components or excipients of the study drug.
* Requirement of prohibited medications during the study.
* Participants who are pregnant, nursing, or planning a pregnancy during the study period.
Primary outcome measure(s)
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 16 — Baseline and week 16 ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain:
* Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
* Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
* Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
* Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
China
Recruiting
More Lynk Pharmaceuticals Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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