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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Care Arthritis Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2026-03-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2025-522118-21-00

WHO UTN

U1111-1328-4802

ClinicalTrials.gov

NCT07018206

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the impact of upadacitinib on the frequency of recurrent acute anterior uveitis (AAU) over 52 weeks in subjects with active axial spondyloarthritis (axSpA) and a prior AAU event in the 104 weeks prior to baseline, who are switching from bDMARDs (in North America and Europe), or who are bDMARD-naïve (in Europe), in real-world practice.

Secondary objectives 3

1. To evaluate the impact of upadacitinib on diverse aspects of chronic pain, disease activity, quality of life, function, and sleep over 52 weeks, in bDMARD-naïve and bDMARD-inadequate responder (bDMARD-IR) subjects, in real-world practice
2. To evaluate the clinical efficacy of upadacitinib 15 mg once daily (QD) on concomitant axial and peripheral clinical efficacy parameters over 52 weeks in bDMARD-naïve and bDMARD-IR subjects
3. To assess the safety and tolerability of upadacitinib 15 mg QD in adult subjects with active axSpA and a prior history of an AAU event in bDMARD-naïve and bDMARD-IR subjects

Conditions and MedDRA coding

Acute Anterior Uveitis

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

It is unknown at this time whether the IPD will be shared.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 16

1. Subject is ≥18 years of age at the screening visit.
2. 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.
3. For nr-axSpA subjects: must have objective signs of inflammation (elevated CRP and/or positive MRI) based on standard-of-care.
4. 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.
5. 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.
6. Subjects on csDMARDs must discontinue and wash out for ≥28 days prior to baseline.
7. If on bDMARD at screening, must undergo appropriate washout per local SOC.
8. Able to understand, willing to adhere to protocol requirements, and provides written informed consent before any study procedures.
9. Diagnosis of axial spondyloarthritis (axSpA) by a treating rheumatologist.
10. Classification of axSpA according to the 2009 ASAS Classification Criteria.
11. 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)
12. Historical documentation of AAU by an ophthalmologist at any time in the past.
13. 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.
14. Inadequate response to ≥2 different NSAIDs over at least 4 weeks total at maximum tolerated doses, or documented intolerance/contraindication to NSAIDs.
15. Mixed population of: bDMARD-naïve subjects, and bDMARD-inadequate responders (bDMARD-IR) or bDMARD-intolerant subjects.
16. Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Exclusion criteria 15

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in exposure-adjusted opthalmologist (or optometrist or rheumatologist)-diagnosed AAU event rate per 100 patient years (EAER) over 52 weeks on upadacitinib compared to the AAU EAER in the 104 week pre-study period, separately in bDMARD-naive and bDMARD experienced groups.

Secondary endpoints 4

1. Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at week 24 in (i) bDMARD-IR (ii) bDMARD-naive groups
2. Percentage of participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at weeks 24 and 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups
3. Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of less than or equal to 5, up to week 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups
4. Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs), AEs and AESIs leading to withdrawal from study drug, and serious AEs (SAEs).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Care Arthritis Ltd.

Sponsor organisation

Care Arthritis Ltd.

Address

316 Windermere Road Northwest Unit 210

City

Edmonton

Postcode

T6W 2Z8

Country

Canada

Scientific contact point

Organisation

Care Arthritis Ltd.

Contact name

Dr. Walter Maskymowych

Public contact point

Organisation

Care Arthritis Ltd.

Contact name

Jessica Restall-Pinder

Third parties 3

Locations

6 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 126 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications