Effect of Upadacitinib on the Frequency of Acute Recurrent Anterior Uveitis in Patients With Axial Spondyloarthritis: A Real-World Study

Trial ID: 2025-522118-21-00
Protocol: B25-723
Sponsor: Care Arthritis Ltd.

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Diseases & Conditions

Axial spondyloarthritis Iridocyclitis

Objectives

The primary objective is to evaluate the impact of upadacitinib on the frequency of recurrent acute anterior uveitis over 52 weeks in subjects with active axial spondyloarthritis and a prior history of the ocular condition. This assessment is clinically relevant to determining the role of the therapeutic agent in managing extra-articular manifestations in patients who are either biological disease-modifying antirheumatic drug (bDMARD)-naïve or switching from existing biological therapies. 5: Efficacy.

Secondary objectives include:

Evaluation of chronic pain, disease activity, quality of life, physical function, and sleep over 52 weeks.
Assessment of the clinical efficacy of 15 mg once daily upadacitinib on concomitant axial and peripheral clinical efficacy parameters. 5: Efficacy.
Assessment of the safety and tolerability of the 15 mg once daily dose. 4: Safety.

Participants

This study involves 70 participants diagnosed with axial spondyloarthritis and acute anterior uveitis. The study population includes both male and female adults. Selection is based on the 2009 ASAS Classification Criteria and a documented history of uveitis within 104 weeks prior to baseline. Participants must demonstrate active disease, characterized by a BASDAI score of ≥ 4 and total back pain of ≥ 4. The cohort consists of a mixed population of biologic disease-modifying antirheumatic drug-naïve subjects and those with inadequate response or intolerance to previous biologic therapy, with specific regional treatment requirements. Key inclusion criteria involve an inadequate response to non-steroidal anti-inflammatory drugs or documented intolerance. Females of childbearing potential must maintain effective contraception and provide negative pregnancy test results.

Plans and Procedures

This Phase IV study is designed to evaluate the impact of upadacitinib on the frequency of recurrent acute anterior uveitis in patients diagnosed with axial spondyloarthritis. The research methodology focuses on assessing the change in the exposure-adjusted event rate of diagnosed uveitis events over a 52-week period compared to the 104 weeks prior to baseline. The study includes a screening visit to confirm eligibility based on ASAS classification criteria, disease activity, and prior medical history. Following screening, participants will undergo a baseline assessment and subsequent follow-up visits throughout the 52-week treatment duration to monitor disease activity and the incidence of adverse events. Total participant involvement is expected to last approximately 52 weeks. Early termination from the study may occur if an investigator determines a subject is unsuitable for participation or if specific protocol requirements regarding contraception or medication washout are not met.

Treatment

The experimental treatment consists of upadacitinib administered as 15 mg prolonged-release tablets. This medication is delivered via the oral route of administration.

Efficacy

The primary efficacy endpoint is the change in the exposure-adjusted event rate (EAER) of acute anterior uveitis (AAU) per 100 patient years over 52 weeks. This rate is diagnosed by an ophthalmologist, optometrist, or rheumatologist and is compared to the AAU EAER observed during the 104-week pre-study period. Evaluation is conducted separately for biologic disease-modifying antirheumatic drug (bDMARD)-naïve and bDMARD-experienced groups.

Secondary efficacy assessments include:

The percentage of participants achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity (LDA [< 2.1]) at week 24 and week 52 in both bDMARD-inadequate responder (bDMARD-IR) and bDMARD-naïve groups.
The percentage of participants achieving an Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) score of less than or equal to 5 up to week 52 in both bDMARD-IR and bDMARD-naïve groups.
The incidence of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs), including those leading to withdrawal from study drug.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Subject is ≥18 years of age at the screening visit.
Treatment history requirements by region: Europe: may be bDMARD-naïve (up to 100 subjects) or bDMARD-IR/intolerant. USA: must have received TNFi and be a TNFi-inadequate responder or intolerant. Canada: must have previously received a bDMARD and be bDMARD-IR or intolerant.
For nr-axSpA subjects: must have objective signs of inflammation (elevated CRP and/or positive MRI) based on standard-of-care.
Contraception/pregnancy-related requirements for females of childbearing potential: Negative serum pregnancy test at screening and negative urine pregnancy test at baseline. Must use protocol-specified birth control methods from Day 1 through at least 30 days after the last dose. Must not be pregnant, breastfeeding, or planning pregnancy during study and for 30 days after last dose.
Stable doses required before baseline for the following medications: NSAIDs or analgesics (including low-potency opioids) for ≥7 days. Oral corticosteroids (≤10 mg prednisone equivalent/day) for ≥14 days.
Subjects on csDMARDs must discontinue and wash out for ≥28 days prior to baseline.
If on bDMARD at screening, must undergo appropriate washout per local SOC.
Able to understand, willing to adhere to protocol requirements, and provides written informed consent before any study procedures.
Diagnosis of axial spondyloarthritis (axSpA) by a treating rheumatologist.
Classification of axSpA according to the 2009 ASAS Classification Criteria.
History of at least one acute anterior uveitis (AAU) event in the 104 weeks prior to baseline, diagnosed by an ophthalmologist (or optometrist/rheumatologist as necessary)
Historical documentation of AAU by an ophthalmologist at any time in the past.
Active axSpA disease, defined by: BASDAI ≥ 4, and Total Back Pain (TBP) ≥ 4 on a 0–10 numerical rating scale at both screening and baseline.
Inadequate response to ≥2 different NSAIDs over at least 4 weeks total at maximum tolerated doses, or documented intolerance/contraindication to NSAIDs.
Mixed population of: bDMARD-naïve subjects, and bDMARD-inadequate responders (bDMARD-IR) or bDMARD-intolerant subjects.
Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

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Exclusion Criteria

Subject with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases)
Primary or secondary immunodeficiency
Previous exposure to upadacitinib or other Janus kinase (JAK) inhibitors
Use of any investigational drug or device within 30 days or five half-lives (whichever is longer) prior to baseline.
Use of systemic immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine) within 28 days prior to baseline.
Evidence of active, serious, or chronic infection, including localized infections.
Known history of, or active, tuberculosis (TB), or latent TB without completion of adequate anti-TB therapy prior to baseline.
Chronic infection of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other clinically significant viral infection.
Current or recent (within 5 years) malignancy, except for adequately treated non-melanoma skin cancer or in situ cervical cancer.
History of major adverse cardiovascular event (MACE), including but not limited to myocardial infarction and cerebrovascular accident
Clinically significant laboratory abnormalities at screening (e.g., hemoglobin < 9 g/dL, ALT or AST > 2 × ULN, eGFR < 30)
Positive pregnancy test at screening or baseline.
Any gastrointestinal condition or surgical history that could interfere with the absorption of oral medication.
Subject who is breastfeeding or planning pregnancy during the study or within 30 days after the last dose.
History of hypersensitivity to upadacitinib or any of its components

Trial Status by Country

Country	Status	Start of Recruitment	Planned Patients
Bulgaria	Not Yet Recruiting	01 Apr 2026	20
France	Not Yet Recruiting	01 Apr 2026	30
Germany	Not Yet Recruiting	01 Apr 2026	10
The Netherlands	Not Yet Recruiting	01 Apr 2026	—
Poland	Not Yet Recruiting	01 Apr 2026	30
Spain	Not Yet Recruiting	01 Apr 2026	30
Netherlands	—	—	10