Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

NCT07018206 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: B25-723
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Axial Spondylarthritis (axSpA)

Keywords

Axial Spondyloarthritis; Acute Anterior Uveitis

Outcome Measures

Primary Outcomes (1)

• Frequency of recurrent acute anterior uveitis (AAU)

  To evaluate the impact of upadacitinib on the frequency of recurrent acute anterior uveitis (AAU) over 52 weeks in subjects with active axSpA and a prior AAU event in the 52 weeks prior to baseline, who are switching from bDMARD (North America and Europe), or who are NSAID-IR and bDMARD naïve (Europe), in real world practice.

  52 Weeks

Secondary Outcomes (2)

• Proportion of participants achieving low disease activity (ASDAS LDA) at Week 24

  Week 24

• Proportion of participants achieving ASAS Health Index (ASAS-HI) ≤5 at Week 52

  Week 52

Study Arms (1)

Upadacitinib

EXPERIMENTAL

All participants enrolled in the study will receive 15 mg of Upadacitinib per day for 52 weeks.

Drug: Upadacitinib 15 MG [Rinvoq]

Interventions

Upadacitinib 15 MG [Rinvoq] DRUG

15mg tablet once per day

Upadacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• For all females of child-bearing potential: must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥3 days later to document continued lack of a positive result (unless prohibited by local requirements).
• Subjects who are regularly taking NSAIDs or analgesics (including low potency opioids) as part of their axSpA therapy are required to be on a stable dose/dose regimen for at least 7 days prior to the baseline visit. If entering the study on concomitant tramadol, combination of acetaminophen/paracetamol and codeine or combination of acetaminophen/paracetamol and hydrocodone, and/or non-opioid analgesics, subject must be on stable dose(s) for at least 7 days prior to the baseline Visit. However, subject must not have used opioid analgesics (except for combination of acetaminophen/paracetamol and codeine or combination of acetaminophen/paracetamol and hydrocodone which are allowed) within 7 days prior to the BL Visit.
• Subjects taking oral corticosteroids must be on an average daily and stable dose of ≤10mg/day prednisone or equivalent for at least 14 days prior to the baseline visit.
• Subjects entering the study on the following concomitant csDMARDs must be on a stable dose as indicated below for at least 28 days prior to the baseline Visit (in case of Leflunomide washout must be either 11 days with colestyramine or 30 days with activated charcoal or as per local label). A combination of up to 2 background csDMARDs is allowed EXCEPT the combination of methotrexate (MTX) and leflunomide. • MTX (≤ 25 mg/week); or • Sulfasalazine (SSZ) (≤ 3 g/day); or • Hydroxychloroquine (≤ 400 mg/day); or • Chloroquine (≤ 250 mg/day); or • Leflunomide (≤ 20 mg/day)
• If subjects are currently taking bDMARD therapy, they may be recruited after an appropriate wash-out period of bDMARD prior to the Baseline Visit. Washout periods are as follows: 4 weeks for Etanercept, 8 weeks for Infliximab, Golimumab, and Certolizumab, 10 weeks for Adalimumab, and Ixekizumab, 12 weeks for Secukinumab. However, subjects should not stop their previous successful biological therapy only to be included in this study. For subjects intolerant to bDMARD and not on such treatment a washout period may not be necessary.

You may not qualify if:

• 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.
• 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.
• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 4 weeks following the last dose of study drug.
• Subjects with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases, e.g., systemic lupus erythematosus, Sjögren´s syndrome, RA, unequivocal chronic fatigue syndrome, or unequivocal fibromyalgia. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease within 4 weeks prior to BL.
• Concomitant treatment with strong inductors or inhibitors of cytochrome P450 3A (e.g., Ketoconazole, Fluconazole, Rifampicin, Clarithromycin, St-John´s-wort).
• Prior treatment with upadacitinib or another JAK-inhibitor or TYK2-inhibitor for axSpA.
• History of hypersensitivity to any component of upadacitinib tablets.
• Treatment with intravenous, intramuscular or intraarticular/periarticular, or intrarectal steroids within 4 weeks prior to baseline Visit; treatment with oral steroids in a dose of \>10 mg prednisolone equivalent per day within 4 weeks prior to baseline visit.
• Subject must not have been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) prior to the first dose of study drug or is currently enrolled in another interventional clinical study.
• History of an infected joint prosthesis at any time, with the prosthesis still in situ.
• Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous cell or basal cell carcinoma of the cutis or carcinoma in situ of the cervix.

Sponsors & Collaborators

• CARE ARTHRITIS LTD.: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Uveitis, Anterior

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Study Officials

• Walter Maksymowych, Dr.

  CARE ARTHRITIS LTD.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Restall-Pinder

CONTACT

5874009524; jessica.restall-pinder@carearthritis.com

Amanda Carapellucci

CONTACT

5874009524; amanda.carapellucci@carearthritis.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 12, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)