Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06085534
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06085534
Study Brief:
Protocol Section:
NCT06085534