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

3 1 1 1

What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Fundación para la investigación biomédica de Córdoba	Cordoba	Spain
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Rheumazentrum Ruhrgebiet	Herne	Germany
Клиника по Ревматология, УМБАЛ „Св. Иван Рилски” ЕАД	Sofia	Bulgaria
Nuuzepvc Ioqylcop Gaeylcfwv Rrcsjedigrsa I Rybvyymtdlefa Id Phntw Dq Hdhv Mdnt Edesawub Rpewgfw	Warsaw	Poland
Pxpo Trcbq Htonpfzw Upmimcjqzibz	Sabadell	Spain
Sqsrrzt Uroqdzdrbdlmx W Kwxczsix	Cracow	Poland
Aldpqwslwq Pqhivmyn Hpohtxkn Dk Pjadp	Paris	France
Cjxjed Hvxsjcoyrwi Rgblgonw Uphhswcwdidww Dz Tueoi	Tours	France
Fonxmfivi Pbij Ln Ihdalydeqdvbm Bkrbszarg Dxc Hmfsnsbu Uqhloqpkokmky Lc Pdx	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	01.04.2026
France	Not yet recruiting	01.04.2026
Germany	Not yet recruiting	01.04.2026
Poland	Not yet recruiting	01.04.2026
Spain	Not yet recruiting	01.04.2026
The Netherlands	Not yet recruiting	01.04.2026

Trial locations

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.

Investigated diseases:

Axial spondyloarthritis

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 ID:

2025-522118-21-00

Protocol code:

B25-723

NCT ID:

NCT07018206

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?