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

Lynk Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: LNK01001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07237568

LK001302

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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352 participants in 2 patient groups, including a placebo group

LNK01001 12mg

Experimental group

Description:

Participants receive LNK01001 12mg orally BID for 52 weeks.

Treatment:

Drug: LNK01001

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: LNK01001