A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LNK01001 Dose A Participants will receive LNK01001 Dose A BID for 24 weeks. |
Drug: LNK01001 Dose A
Capsules taken orally
|
| Experimental: LNK01001 Dose B Participants will receive LNK01001 Dose B BID for 24 weeks. |
Drug: LNK01001 Dose B
Capsules taken orally
|
| Placebo Comparator: placebo Participants will receive Placebo BID for 12 weeks. |
Drug: Placebo
Capsules taken orally
|
Outcome Measures
Primary Outcome Measures
- Treatment Emergent Adverse Events (TEAE), serious adverse event (SAE), adverse events leading to discontinuation [week 24]
- Percentage of Participants with Assessment of Spondylo Arthritis International Society (ASAS) 40 Response [Week 12]
Secondary Outcome Measures
- Percentage of Participants with an ASAS40 [Week 8,16,24]
- Percentage of Participants with an ASAS20 [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]
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [Week 8,12,16,24]
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) -CRP [Week 8,12,16,24]
- Change From Baseline in CRP [Week 8,12,16,24]
- Change From Baseline in ASQoL [Week 8,12,16,24]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | China |
Sponsors and Collaborators
- Lynk Pharmaceuticals Co., Ltd
Investigators
- Principal Investigator: Xiaofeng Zeng, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LK001203