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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
CARE ARTHRITIS LTD.
Study ID
NCT07018206
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Axial Spondylarthritis (axSpA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Frequency of recurrent acute anterior uveitis (AAU) [ Time Frame: 52 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Dr. Alexis Ogdie
[email protected]
215-662-2454
Dr. Alexis Ogdie (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania· Philadelphia, PA