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Study to evaluate the effect of upadacitinib on the frequency of eye inflammation in patients with axial spondyloarthritis.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate how upadacitinib affects the occurrence of eye inflammation in people living with Axial Spondyloarthritis. Axial Spondyloarthritis is a type of long-term inflammatory disease that primarily affects the spine and the joints around it. Some individuals with this condition also experience Acute Anterior Uveitis, which is a sudden inflammation inside the front part of the eye that can cause redness, pain, and vision changes.

Participants in this research will be given upadacitinib, which is an oral medication taken in the form of a prolonged-release tablet. This type of pill is designed to release the medicine slowly into the body over time. The study will follow the participants over a period of 52 weeks to observe how frequently episodes of eye inflammation occur while taking the medication.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    You will take rinvoq, which contains the active substance upadacitinib, as a prolonged-release tablet.

    The dosage is 15 mg and is taken orally (by mouth).

  2. Step 2

    <b>study observation period</b>

    The observation period for this study lasts for 52 weeks.

    During this time, the frequency of acute anterior uveitis (inflammation of the front part of the eye) will be monitored.

    The study also tracks how axial spondyloarthritis (a type of inflammatory arthritis affecting the spine) is managed throughout the 52 weeks.

Who can join the trial?

14 criteria

  • You must be at least 18 years old at the time of the initial screening.
  • You must have a diagnosis of axial spondyloarthritis, which is a type of long-term inflammatory arthritis that primarily affects the spine, confirmed by a rheumatologist (a doctor who specializes in arthritis and joint diseases).
  • Your axial spondyloarthritis must be currently active, meaning you have high scores on specific pain and disease activity scales (BASDAI and Total Back Pain) during the check-up.
  • You must have a history of at least one episode of acute anterior uveitis, which is inflammation in the middle layer of the eye, occurring within the 104 weeks before the study starts.
  • This eye inflammation must have been documented by an eye specialist, such as an ophthalmologist.
  • You must have had an inadequate response to at least two different NSAIDs (non-steroidal anti-inflammatory drugs, which are medicines used to reduce pain and swelling) for at least 4 weeks, or you must be unable to take these medicines due to side effects or medical reasons.
  • Depending on where you live, you must meet specific treatment history rules: in Europe, you may be bDMARD-naïve (meaning you have never taken biologic disease-modifying antirheumatic drugs) or have not responded well to them; in the USA, you must have tried and not responded well to a TNFi (a specific class of biologic medicine); in Canada, you must have previously taken a bDMARD but did not get enough relief or could not tolerate it.
  • If you have non-radiographic axial spondyloarthritis (a form of the disease where changes might not show up on standard X-rays), you must show signs of inflammation through blood tests (CRP, a marker of inflammation) or an MRI (a detailed medical imaging scan).
  • Women who can become pregnant must have a negative pregnancy test, must not be breastfeeding, and must agree to use specific birth control methods throughout the study and for 30 days after the last dose.
  • You must be on a stable dose of certain medicines for a set period before the study: NSAIDs or pain medicines for at least 7 days, and low-dose oral corticosteroids (steroid medicines used to reduce inflammation) for at least 14 days.
  • If you are taking csDMARDs (conventional synthetic disease-modifying antirheumatic drugs), you must stop taking them and allow a washout period (the time it takes for a drug to leave your body) of at least 28 days before the study begins.
  • If you are taking a bDMARD, you must follow local medical guidelines to stop the medication before the study starts.
  • You must be able to understand the study requirements, be willing to follow them, and provide written informed consent (a signed document showing you agree to participate) before any study activities begin.
  • You must not have any other health conditions that, in the opinion of the doctor in charge of the study, would make it unsafe or unsuitable for you to participate.

Who cannot join the trial?

15 criteria

  • Having a long-term inflammatory joint disease, other than axial spondyloarthritis (a type of spine inflammation) or other autoimmune diseases (conditions where the body's immune system attacks its own healthy cells).
  • A history of a major adverse cardiovascular event, which means a serious heart or blood vessel problem, such as a myocardial infarction (heart attack) or a cerebrovascular accident (stroke).
  • Having clinically significant laboratory abnormalities, which are unhealthy results from blood or urine tests, such as low hemoglobin (a protein in red blood cells that carries oxygen), high ALT or AST (levels of enzymes that show liver health), or a low eGFR (a measure of how well the kidneys are filtering waste).
  • Testing positive for pregnancy at the start of the study.
  • Having any gastrointestinal condition (problems with the stomach or intestines) or a history of surgery in that area that might stop the body from properly absorbing medicine taken by mouth.
  • Being breastfeeding or planning to become pregnant during the study or within 30 days after the last dose of medicine.
  • A history of hypersensitivity, which means having an allergic reaction, to the study drug or any of its ingredients.
  • Having a primary or secondary immunodeficiency, which is a condition where the body's immune system is weakened and cannot fight infections well.
  • Having previously taken upadacitinib or other Janus kinase (JAK) inhibitors (a specific type of medicine that affects the immune system).
  • Using any investigational drug or device (a medicine or tool being tested in a study) within 30 days or a specific timeframe before the study begins.
  • Using systemic immunosuppressants, which are medicines that lower the body's ability to fight infection, within 28 days before the study begins.
  • Showing signs of an active, serious, or chronic infection, including infections in one specific part of the body.
  • A known history of, or active, tuberculosis (TB), or having latent TB (a sleeping form of the infection) without having finished the full required treatment.
  • Having a chronic infection such as HIV, hepatitis B, hepatitis C, or other important viral infections.
  • Having a current or recent malignancy (cancer) within the last 5 years, though this does not apply to certain types of skin cancer or early-stage cervical cancer that have been treated.
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Investigated drugs

Upadacitinib is a medication taken by mouth that is being studied to see if it can reduce how often people with axial spondyloarthritis experience sudden inflammation in the front part of the eye, known as acute anterior uveitis.

What is already known about the treatment

Upadacitinib - This medication is taken as a pill that is swallowed once a day and is designed to release the medicine slowly into the body over time. It is a known treatment used for various inflammatory conditions, including certain types of arthritis, and it works by blocking specific proteins called Janus kinases that act as messengers for inflammation inside cells. By stopping these messengers, the drug helps to reduce the swelling and pain caused by an overactive immune system. It is classified as a JAK inhibitor and is currently used to manage autoimmune diseases.

Investigated diseases

  • Acute Anterior Uveitis

    This is an inflammation occurring in the front part of the eye. It primarily affects the iris and the ciliary body. The condition often presents as sudden redness, pain, and light sensitivity in the affected eye. It can occur as a single episode or recur multiple times over a person's life.

  • Axial Spondyloarthritis

    This is a chronic inflammatory disease that primarily affects the spine and the joints connecting the spine to the pelvis. It involves ongoing inflammation in these areas, which can lead to stiffness and discomfort. Over time, the inflammation may cause the joints to become less flexible. The condition typically progresses by causing persistent pain in the lower back and hips.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522118-21-00Protocol codeB25-723Estimated enrolment200 patientsSponsorCare Arthritis Ltd.

sourced from the EU Clinical Trials Register and site verification

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