Active not recruitingPHASE3INTERVENTIONAL

A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis

This research study is testing a new medication called brepocitinib. It's for adults aged 18 to 75 who have a specific kind of eye inflammation known as non-infectious uveitis. This condition affects different parts of the eye and isn't caused by germs. The study wants to find out if brepocitinib is a safe and effective way to treat this inflammation. Participants will either receive the new medication or a placebo (a dummy pill with no active drug) to compare their effects. This is a Phase 3 study, which means it's a later stage of research, usually involving a larger number of people to gather more information on effectiveness and safety.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Priovant Therapeutics, Inc.

Enrolment target

371

Start

11 Sep 2024

Estimated completion

01 Feb 2028

Uveitis, Posterior Uveitis, Intermediate Uveitis

What is this study about?

You might be reading this because you or someone you know has uveitis, which is inflammation inside the eye. It can cause pain, redness, blurry vision, and even lead to serious vision problems if not treated. This particular study is focusing on a type called 'non-infectious uveitis', meaning it's not caused by bacteria, viruses, or other infections. It can affect the middle, back, or all parts of your eye.

The study is investigating a new drug called brepocitinib. This medication is taken by mouth once a day. Researchers want to see if it can help control the inflammation in your eye and improve your symptoms. They will also be carefully monitoring for any side effects to make sure the drug is safe.

The study is in 'Phase 3', which means it's one of the final steps before a new drug can be considered for wider use. It involves comparing brepocitinib to a 'placebo' (a pill that looks the same but contains no active drug). This helps the researchers understand if brepocitinib is truly making a difference compared to no active treatment.

Key takeaways

This study is for adults with a non-infectious type of eye inflammation called uveitis.
It's testing a new medication called brepocitinib, taken as a pill once a day.
The study aims to see if brepocitinib is safe and helps reduce eye inflammation.
Half of the participants will receive brepocitinib, and half will receive a dummy pill (placebo).
You will have regular check-ups and monitoring during the study period.
You can stop taking part at any time without affecting your normal medical care.

Who may be eligible?

This study is looking for adults between 18 and 75 years old who have been diagnosed with a specific type of non-infectious uveitis. This could be uveitis affecting the middle part of the eye (intermediate), the back part (posterior), or all parts of the eye (panuveitis), and it must be active at the moment.

To join, you should weigh more than 40 kg (about 6 stone 4 pounds) and have a body mass index (BMI) of 40 or less. Your doctor can help you check your BMI.

There are some reasons why you wouldn't be able to join. For example, if your uveitis is thought to be caused by an infection, or if you have a history of certain cancers (with some exceptions like certain skin cancers), or if you've had a blot clot or stroke in the last year. Also, if you're at high risk for shingles or have an active infection, you wouldn't be eligible.

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 between 18 and 75 years old?
Have you been diagnosed with non-infectious uveitis that affects the middle or back of your eye, or all of your eye?
Is your uveitis currently active in at least one eye?
Do you weigh more than 40 kg (about 6 stone 4 pounds) and have a Body Mass Index (BMI) of 40 or less?
Have you *not* had certain serious health issues like recent cancer (with some exceptions) or blood clots in the last year?
Is your uveitis *not* caused by an infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to attend several appointments at the study clinic. During these visits, the research team would carry out various assessments, including checking your eyesight, blood tests, and other examinations related to your eye health. All participants will take a study medication by mouth once a day – half of the participants will receive brepocitinib, and the other half will receive a placebo, but neither you nor your study doctor will know which you are taking until the study ends. You will be closely monitored throughout the study for both the effects of the medication and any potential side effects. The total length of your participation would be discussed in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new medication before it's widely available and more frequent medical monitoring. However, there are also potential risks involved, like experiencing side effects from the study medication or the possibility that the treatment may not help your condition. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (107)

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

Clinical Trial Site
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Phoenix, United States
Clinical Trial Site
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Phoenix, United States
Clinical Trial Site
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Bakersfield, United States
Clinical Trial Site
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Beverly Hills, United States
Clinical Trial Site
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Fullerton, United States
Clinical Trial Site
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Irvine, United States
Clinical Trial Site
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La Jolla, United States
Clinical Trial Site
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Los Angeles, United States
Clinical Trial Site
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Los Angeles, United States
Clinical Trial Site
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Modesto, United States
Clinical Trial Site
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Sacramento, United States
Clinical Trial Site
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Aurora, United States

Common questions

What is non-infectious uveitis?

It's an inflammation inside your eye that is not caused by germs like bacteria or viruses. It can cause symptoms like redness, pain, and blurry vision.

What is brepocitinib?

Brepocitinib is a new medication being tested to see if it can help control the inflammation in this type of uveitis.

What does 'Phase 3' mean for a study?

Phase 3 is a late stage of research where a new drug is tested in a larger group of people to confirm its effectiveness, monitor side effects, and compare it to existing treatments or a placebo.

Will I know if I'm getting the actual drug or a placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving brepocitinib or the placebo until the study is over.

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

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.