Clinical trial NCT06085534: A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficiency and Safety of LNK01001 Capsule in Patients With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Lead sponsor: Lynk Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percentage of Participants Achieving 40% Improvement in ASAS Score at Week 12.
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving 40% Improvement in ASAS Score at Week 8,16,24
timeFrame: Week 8,16,24
measure: Percentage of Participants Achieving 20% Improvement in ASAS Score.
timeFrame: Week 8,12,16,24
measure: Percentage of Participants with an ASAS 5/6 response.
timeFrame: Week 8,12,16,24
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Week 8,12,16,24
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Week 8,12,16,24
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Week 8,12,16,24
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Week 8,12,16,24
measure: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
timeFrame: Week 8,12,16,24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng
role: PRINCIPAL_INVESTIGATOR
References: