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

NCT07237568 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

DRUG

LNK01001

Capsule; Oral

DRUG

Placebo

Capsule; Oral

Sponsors & Collaborators

  • Lynk Pharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-29
Primary Completion
2026-11-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237568 on ClinicalTrials.gov