Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis (JAKUVEITE)

This research study, called JAKUVEITE, is investigating a new tablet treatment, baricitinib (brand name Olumiant), for a specific type of eye inflammation called non-infectious non-anterior uveitis. This condition causes swelling and irritation in the middle and back parts of the eye, which can affect vision. The study aims to find out if baricitinib, which works by calming the overactive immune system, can help reduce this inflammation effectively. Researchers will be comparing different doses of baricitinib against existing treatments. They will measure how much a patient's condition improves over six months, looking at factors like vision clarity and the level of inflammation inside the eye. It's a Phase III study, meaning it's a large trial to confirm the treatment's safety and effectiveness.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Rouen, Centre Hospitalier Universitaire Rouen

Enrolment target

Start

28 May 2024

Active non-anterior non-infectious uveitis

What is this study about?

This clinical trial is designed to investigate a new treatment for a condition called non-infectious non-anterior uveitis. Uveitis is a general term for inflammation inside the eye, and 'non-infectious' means it's not caused by a germ like a virus or bacteria. 'Non-anterior' means the inflammation is affecting the middle or back part of your eye, rather than just the front. This kind of inflammation can cause blurry vision, pain, and sensitivity to light, and if not treated, it could lead to more serious eye problems.

The new treatment being studied is a tablet called baricitinib, also known by its brand name Olumiant. It belongs to a group of medicines called 'JAK inhibitors'. These drugs work by calming down your body's immune system, which in uveitis, mistakenly attacks your own eye tissues, causing inflammation. The researchers want to see if baricitinib is a safe and effective way to reduce this inflammation and improve eye health over a period of six months.

Researchers will be carefully tracking how well the treatment works. They will be looking at whether the inflammation reduces, if your eyesight improves, and if you can potentially reduce your dose of other medications you might be taking. This study is an important step in finding new and better ways to manage this challenging eye condition, potentially offering a new option for people who haven't responded well to existing treatments.

Key takeaways

Exploring a new tablet (baricitinib) for eye inflammation.
Specifically for non-infectious, non-anterior uveitis.
Aims to reduce inflammation and improve vision over six months.
Involves regular eye check-ups and monitoring.
Could offer a new option for existing treatments.
Your safety and well-being are a top priority.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate.

This study is for people who have active, ongoing non-infectious non-anterior uveitis. This means your eye inflammation is currently affecting the middle or back part of your eye and it's not caused by an infection. Your doctor will be able to confirm if your specific condition fits these criteria.

Both men and women are encouraged to take part in this research. The study aims to include a diverse group of participants to ensure the results are widely applicable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with non-infectious non-anterior uveitis?
Is your uveitis currently active (showing signs of inflammation)?
Are you willing to attend regular appointments for six months?
Are you able to take tablet medication as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either baricitinib tablets or another type of treatment. These treatments include Olumiant 4 mg tablets, Olumiant 2 mg tablets, CORTANCYL 5 mg tablets, or an intravenous injection of FLUOCYNE 10% or FLUORESCEINE SODIQUE FAURE 10%. You will have regular appointments over a six-month period. During these visits, eye specialists will perform various checks and tests to monitor your eye health. These will likely include checking your vision, examining your eyes with special lights (like a 'slit-lamp'), and taking detailed pictures of the inside of your eye. They will also track any changes in your medication dosages, especially steroid medications. The total duration of active treatment and follow-up for this study will be six months.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment for your uveitis that might improve your eye condition and even reduce your need for other medications. However, like all medications, baricitinib and the other treatments might have side effects, and your condition may not improve. The research team will explain all known potential risks in detail, and your safety will be closely monitored throughout the study. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is uveitis?

Uveitis is when the inside of your eye becomes inflamed or swollen. This study focuses on a type not caused by infection, affecting the middle or back of the eye.

What is baricitinib (Olumiant)?

It's a tablet medication that works by calming an overactive immune system to reduce eye inflammation. It's already approved for other conditions like rheumatoid arthritis.

How long will the study last for me?

If you join, you will be part of the study for six months, with regular check-ups during that time.

Will I know if I'm getting the new drug or another treatment?

This is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete, to keep the results fair.

Can I stop participating in the study if I change my mind?

Yes, you are free to withdraw from the study at any point without it affecting your regular medical care.