A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis

Lynk Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: Placebo; Drug: LNK01001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06085534

LK001203

Details and patient eligibility

About

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

Full 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).

Enrollment: 177 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 3 patient groups, including a placebo group

LNK01001 Dose A

Experimental group

Description:

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.

Treatment:

Drug: LNK01001

LNK01001 Dose B

Experimental group

Description:

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.

Treatment:

Drug: LNK01001

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: LNK01001