Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS) (NCT05861102) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)
China265 participantsStarted 2023-07-20
Plain-language summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participants must be able to understand the study and signed the informed consent.
* 18-65 years, male or female.
* Participants with a clinical diagnosis of ankylosing spondylitis (AS), and radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS(1984).
* Participants must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
* Participants may be receiving the following Disease-Modifying Anti-Rheumatic Drugs(DMARDs) at the time of the screening visit. These medications should be continued throughout the entire study and doses should remain unchanged.
* Participants has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs.
* Participants who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation.
* Participants receiving non-prohibited concomitant medications for any reason must be willing to stay on a stable regimen as defined in the protocol.
Exclusion Criteria:
* History of known or suspected complete ankylosis of the spine.…
What they're measuring
1
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 16