NCT06085534

A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficiency and Safety of LNK01001 Capsule in Patients With Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Lynk Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the safety and efficacy of multiple doses of LNK01001 monotherapy versus placebo in the treatment of adults with active Ankylosing Spondylitis

Detailed description

This study includes two periods. In Period 1, Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 Dose A or LNK01001 Dose B or a matching placebo for 12 weeks. Participants who receive a placebo in Period 1 will be re-randomized at Week 13 in a 1:1 ratio to receive a twice daily oral LNK01001 Dose A or LNK01001 Dose B for 12 weeks (period 2). Those participants, based on the ASAS40 response, who receive LNK01001 (Dose A or Dose B) in Period 1 may switch to receive a different treatment dose for 12 weeks (period 2).

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	LNK01001	Capsules for oral use
DRUG	Placebo	Capsules for oral use

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-12-06
• Completion: 2023-06-20
• First posted: 2023-10-17
• Last updated: 2023-10-27

Locations

1 site across 1 country: China