New pill could ease stiffness and pain for ankylosing spondylitis patients
NCT ID NCT05861102
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an oral drug called jaktinib in 265 adults with active ankylosing spondylitis, a type of arthritis that mainly affects the spine. Participants take either jaktinib or a placebo twice daily for 16 weeks. The main goal is to see if jaktinib can reduce pain and improve function by at least 40% compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Jaktinib (an oral drug that targets inflammation)
- What this could lead to
- If successful, jaktinib could offer a new daily pill to control symptoms and slow disease progression for people with ankylosing spondylitis.
- What could go wrong
- This is a relatively small Phase 3 trial, and results may not apply to all patients. Jaktinib may cause side effects like infection risk, and it requires ongoing daily use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
265 people
The number who actually took part.
- Started
-
Jul 2023
- Expected to finish
-
Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * Any subject with condition affecting oral drug absorption. * Participants taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) within 4 weeks before randomization. * Participants on any other DMARDs within 4 weeks or five half-lives (whichever is longer) of the drug prior to the Baseline visit. * Participants has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis, mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age. * Significant trauma or surgery procedure within 8 weeks prior to randomization, or any planned elective surgery during the study period. * Participants with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency. * Participants with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery. * Use of any investigational drug and/or devices within 4 weeks of randomization or a period of 5 half-lives of the investigational drug, whichever is longer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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RenJi Hospital
Shanghai, Shanghai Municipality, 200001, China
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