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

NCT07237568 | Recruiting Phase 3

• 1 other identifier: LK001302
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankylosing Spondylitis

Keywords

LNK01001; AS

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at 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).

  Baseline and week 16

Secondary Outcomes (11)

• Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 20 (ASAS20) Response at Week 16

  Baseline and week 16

• Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 16

  Baseline and week 16

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 16

  Baseline and week 16

• Percentage of Participants With ASDAS Inactive Disease at Week 16

  Baseline and week 16

• Change From Baseline in Patient's Assessment of Total Back Pain at Week 16

  Baseline and week 16

Study Arms (2)

LNK01001 12mg

EXPERIMENTAL

Participants receive LNK01001 12mg orally BID for 52 weeks.

Drug: LNK01001

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo for 16 weeks and then switch to receive LNK01001 12mg orally BID for 36 weeks.

Drug: LNK01001; Drug: Placebo

Interventions

LNK01001 DRUG

Capsule; Oral

LNK01001 12mg; Placebo

Placebo DRUG

Capsule; Oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lynk Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Xiaofeng Zeng

CONTACT

13501069845; xiaofeng.zeng@cstar.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)