Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axia… (NCT07018206) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis
United States200 participantsStarted 2026-05
Plain-language summary
This is a Phase IV, open-label, multicenter study evaluating the impact of upadacitinib on the frequency of acute anterior uveitis (AAU) in adults with axial spondyloarthritis (axSpA) and a documented history of AAU in the prior 52 weeks. Approximately 200 participants will be enrolled across North America and Europe, including both biologic DMARD-inadequate responders (bDMARD-IR) and bDMARD-naïve patients. The primary objective is to assess the change in exposure-adjusted AAU event rate during 52 weeks of treatment with upadacitinib 15 mg once daily. Secondary objectives include evaluating the effect of upadacitinib on disease activity, pain, physical function, quality of life, and sleep. Safety and tolerability will also be assessed throughout the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject ≥18 of age at the screening visit.
. Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
. Diagnosis of axSpA by their treating rheumatologist.
. Classification of axSpA according to ASAS Classification Criteria
. History of at least one acute anterior uveitis event in the 52 week period prior to baseline, diagnosed by an ophthalmologist.
. Active disease as defined by a BASDAI value of ≥4 and TBP score of ≥4 (on a 0-10 NRS scale) at screening and baseline.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of recurrent acute anterior uveitis (AAU)
. History of an inadequate response to at least two different NSAIDs over a period of 4 weeks in total at the maximum recommended or tolerated doses, or intolerance/contraindication (e.g., allergic reaction, gastrointestinal symptoms or signs, severe arterial hypertension, etc.) for NSAIDs.
. Subjects must have been treated for ≥3 consecutive months prior to the study entry with bDMARD therapy and/or for ≥4 weeks of NSAID therapy, in accordance with local product label for AS or nr-axSpA, but continue to exhibit active SpA, or had to discontinue previous bDMARD and/or NSAID treatment due to intolerability or toxicity, irrespective of treatment duration. A total of 50 subjects who are bDMARD-naïve and 150 subjects who are b-DMARD-IR will be included in the study.
Exclusion criteria
. Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral antiinfectives within 14 days prior to the baseline Visit; Chronic recurring infection and/or active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.
. COVID-19: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status
. Suspected COVID-19: subjects with signs/symptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 5 days from a potential exposure;
. History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
. Primary or secondary immunodeficiency.
. Subjects with active TB or who meet TB exclusionary parameters (specific requirements for TB testing are provided in Section 7.0: TB Testing/TB Prophylaxis)
. Chronic infection with hepatitis B virus. At screening HBsAg and anti-HBc will be tested. Subjects who are HBsAg positive will be excluded. In case of HBsAg negativity, but anti-HBc positivity, participation in the study is possible if HBV-DNA testing is negative and no exclusionary liver function tests.
. Chronic infection with hepatitis C (HCV) (HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab), or Human Immunodeficiency Virus (HIV) infection confirmed by positive HIV-antibody and antigen test.