A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis

NCT ID: NCT06085534

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2023-06-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LNK01001 Dose A

Participants were randomized to receive LNK01001 capsule dose A BID orally for 12 weeks in Period 1. At Week 13, participants were re-randomized to LNK01001 dose A or B capsule BID orally for 12 weeks in Period 2.

Group Type: EXPERIMENTAL

LNK01001

Intervention Type: DRUG

Capsules for oral use

LNK01001 Dose B

Participants were randomized to receive LNK01001 capsule dose B BID orally for 12 weeks in Period 1. At Week 13, participants were re-randomized to LNK01001 capsule dose A or B BID orally for 12 weeks in Period 2.

Group Type: EXPERIMENTAL

LNK01001

Intervention Type: DRUG

Capsules for oral use

placebo

Participants were randomized to receive a placebo capsule twice a day (BID) orally for 12 weeks in Period 1. At Week 13 participants were re-randomized to receive LNK01001 capsule dose A or B BID orally for 12 weeks in Period 2.

Group Type: PLACEBO_COMPARATOR

LNK01001

Intervention Type: DRUG

Capsules for oral use

Placebo

Intervention Type: DRUG

Capsules for oral use

Interventions

LNK01001

Capsules for oral use

Intervention Type: DRUG

Placebo

Capsules for oral use

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants between ≥ 18 and ≤75 years of age.
• Diagnosis of ankylosing spondylitis (AS) who meet the 1984 revised New York Criteria for AS.
• Subjects must have disease activity at Screening and baseline visit.
• Subjects have received NSAIDs treatment but still have active AS, or subjects have an intolerance to or contraindication for NSAIDs.
• Never received tumor necrosis factor alpha (TNFα) treatment or prior exposure to ≤1 before randomization.

Exclusion Criteria

• History of infection or any active infection.
• History of malignancy or current diagnosis of malignancy within 5 years before screening visit.
• Previous recipient of an organ transplant.
• Diagnosis of active uveitis within 6 months before randomization.
• Subject with any major surgery (including joint surgery) within 3 months before randomization or planned major surgery within the first 6 months during study.
• Prior exposure to Janus Kinase (JAK) inhibitor.
• Subjects who are allergy to any component of the study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lynk Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaofeng Zeng

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

LK001203

Identifier Type: -

Identifier Source: org_study_id