Upadacitinib for Acute anterior uveitis|Axial spondyloarthritis

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Subject with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases)\n- Primary or secondary immunodeficiency\n- Previous exposure to upadacitinib or other Janus kinase (JAK) inhibitors\n- Use of any investigational drug or device within 30 days or five half-lives (whichever is longer) prior to baseline.\n- Use of systemic immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine) within 28 days prior to baseline.\n- Evidence of active, serious, or chronic infection, including localized infections.\n- Known history of, or active, tuberculosis (TB), or latent TB without completion of adequate anti-TB therapy prior to baseline.\n- Chronic infection of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other clinically significant viral infection.\n- Current or recent (within 5 years) malignancy, except for adequately treated non-melanoma skin cancer or in situ cervical cancer.\n- Clinically significant laboratory abnormalities at screening (e.g., hemoglobin < 9 g/dL, ALT or AST > 2 × ULN, eGFR < 30)\n- Positive pregnancy test at screening or baseline.\n- Any gastrointestinal condition or surgical history that could interfere with the absorption of oral medication.\n- Subject who is breastfeeding or planning pregnancy during the study or within 30 days after the last dose.\n- History of hypersensitivity to upadacitinib or any of its components"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"EAER (exposure-adjusted event rate) per 100 patient-years over 52 weeks on upadacitinib compared with the AAU EAER in the 104-week pre-study period; events diagnosed by ophthalmologist (or optometrist or rheumatologist); analysis performed separately for bDMARD-naive and bDMARD-experienced groups."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants with ASDAS LDA (<2.1) at week 24, reported separately for bDMARD-IR and bDMARD-naive groups."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants with ASDAS LDA (<2.1) at weeks 24 and 52, reported separately for bDMARD-IR and bDMARD-naive groups."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants achieving ASAS-HI ≤5 up to week 52, reported separately for bDMARD-IR and bDMARD-naive groups."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Incidence counts and rates of AEs, AESIs, drug-withdrawal AEs/AESIs, and SAEs collected during the study treatment period and reported as frequencies and rates."}

Bulgaria

Earliest CTIS Part Ii Submission Date

09-12-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

94

Number Of Sites

2

Number Of Participants

20

France

Earliest CTIS Part Ii Submission Date

07-01-2026

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

68

Number Of Sites

3

Number Of Participants

30

Germany

Earliest CTIS Part Ii Submission Date

20-02-2026

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

21

Number Of Sites

1

Number Of Participants

10

Spain

Earliest CTIS Part Ii Submission Date

27-01-2026

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

49

Number Of Sites

3

Number Of Participants

30

Netherlands

Earliest CTIS Part Ii Submission Date

02-03-2026

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

14

Number Of Sites

1

Number Of Participants

10

Poland

Earliest CTIS Part Ii Submission Date

04-03-2026

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

19

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

Care Arthritis Ltd.

Organisation Type

Educational Institution

Country Of Registered Address

Canada

Contract research organisations

Name

JSS Medical Research Europe Sp. z o.o.

Responsibilities

sponsorDuties codes: 1,5

Name

PCI Pharma Services Germany GmbH

Responsibilities

sponsorDuties codes: 14

Name

Castor EDC

Responsibilities

sponsorDuties codes: 7

Third parties

• {"country":"Poland","full_name":"JSS Medical Research Europe Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1,5","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Castor EDC","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Industry"}