A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis

NCT06085534 | Completed Phase 2

• 1 other identifier: LK001203
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 40% Improvement in ASAS Score at Week 12.

  ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

  Week 12

Secondary Outcomes (8)

• Percentage of Participants Achieving 40% Improvement in ASAS Score at Week 8,16,24

  Week 8,16,24

• Percentage of Participants Achieving 20% Improvement in ASAS Score.

  Week 8,12,16,24

• Percentage of Participants with an ASAS 5/6 response.

  Week 8,12,16,24

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Week 8,12,16,24

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

  Week 8,12,16,24

Study Arms (3)

LNK01001 Dose A

EXPERIMENTAL

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.

Drug: LNK01001

LNK01001 Dose B

EXPERIMENTAL

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.

Drug: LNK01001

placebo

PLACEBO COMPARATOR

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.

Drug: LNK01001; Drug: Placebo

Interventions

LNK01001 DRUG

Capsules for oral use

LNK01001 Dose A; LNK01001 Dose B; placebo

Placebo DRUG

Capsules for oral use

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lynk Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Xiaofeng Zeng

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: January 6, 2022
• Primary Completion: December 6, 2022
• Study Completion: June 20, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

CN (1)