Back to resultsA Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LNK01001 Dose A
LNK01001 Dose B
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
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.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
LNK01001 Dose A
LNK01001 Dose B
placebo
Arm Description
Participants will receive LNK01001 Dose A BID for 24 weeks.
Participants will receive LNK01001 Dose B BID for 24 weeks.
Participants will receive Placebo BID for 12 weeks.
Outcomes
Primary Outcome Measures
Treatment Emergent Adverse Events (TEAE), serious adverse event (SAE), adverse events leading to discontinuation
Percentage of Participants with Assessment of Spondylo Arthritis International Society (ASAS) 40 Response
Secondary Outcome Measures
Percentage of Participants with an ASAS40
Percentage of Participants with an ASAS20
Percentage of Participants with an ASAS 5/6 response
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) -CRP
Change From Baseline in CRP
Change From Baseline in ASQoL
Full Information
NCT ID
NCT06085534
First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Lynk Pharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT06085534
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
June 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lynk Pharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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 matching placebo for 12 weeks. Participants who receive 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LNK01001 Dose A
Arm Type
Experimental
Arm Description
Participants will receive LNK01001 Dose A BID for 24 weeks.
Arm Title
LNK01001 Dose B
Arm Type
Experimental
Arm Description
Participants will receive LNK01001 Dose B BID for 24 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
LNK01001 Dose A
Intervention Description
Capsules taken orally
Intervention Type
Drug
Intervention Name(s)
LNK01001 Dose B
Intervention Description
Capsules taken orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules taken orally
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events (TEAE), serious adverse event (SAE), adverse events leading to discontinuation
Time Frame
week 24
Title
Percentage of Participants with Assessment of Spondylo Arthritis International Society (ASAS) 40 Response
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants with an ASAS40
Time Frame
Week 8,16,24
Title
Percentage of Participants with an ASAS20
Time Frame
Week 8,12,16,24
Title
Percentage of Participants with an ASAS 5/6 response
Time Frame
Week 8,12,16,24
Title
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame
Week 8,12,16,24
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame
Week 8,12,16,24
Title
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame
Week 8,12,16,24
Title
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) -CRP
Time Frame
Week 8,12,16,24
Title
Change From Baseline in CRP
Time Frame
Week 8,12,16,24
Title
Change From Baseline in ASQoL
Time Frame
Week 8,12,16,24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis
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