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Study on the Effects of Brepocitinib and Prednisone for Adults with Active Non-Infectious Uveitis

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What is this trial about?

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

This clinical trial is focused on studying a condition called non-infectious uveitis, which is an inflammation inside the eye that is not caused by an infection. The study specifically looks at three types of this condition: intermediate uveitis, posterior uveitis, and panuveitis. The main treatment being tested in this study is a medication called brepocitinib, which is taken orally in the form of a tablet. The study also involves the use of a placebo tablet, which looks like the brepocitinib tablet but does not contain the active medication.

The purpose of the study is to evaluate how effective brepocitinib is in treating the inflammation associated with non-infectious uveitis. Participants in the study will be randomly assigned to receive either brepocitinib or a placebo. The study will last for a period of up to 96 weeks, during which participants will take the medication and attend regular check-ups to monitor their condition and any changes in their symptoms.

Throughout the study, doctors will closely observe the participants to see how well the treatment works and to ensure their safety. The study aims to provide valuable information on whether brepocitinib can help reduce the inflammation and improve the symptoms of non-infectious uveitis. This research could potentially lead to better treatment options for people living with this eye condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age (18-75 years), diagnosis of non-infectious uveitis (intermediate, posterior, or panuveitis), active disease in at least one eye, and a weight greater than 40 kg with a body mass index of 40 kg/m² or less.

  2. Step 2

    Medication administration

    Participants receive oral medication. The study involves the use of brepocitinib tablets, as well as prednisone tablets in varying dosages (5 mg, 10 mg, and 20 mg).

    A placebo tablet is also used to match the 45 mg brepocitinib tablet. The specific dosage and frequency of administration are determined by the study protocol.

  3. Step 3

    Monitoring and evaluation

    Participants are monitored regularly to evaluate the effectiveness of the treatment. This includes assessing the time to treatment failure from Week 6 up to Week 48.

    Secondary evaluations include the proportion of participants meeting treatment failure criteria from Week 6 to Week 24, changes in visual acuity, and changes in central subfield thickness in each eye from the best state achieved at or prior to Week 6 up to Week 48.

  4. Step 4

    Study duration

    The study is estimated to conclude by February 1, 2028. Recruitment for the study is expected to start on February 1, 2025.

Who can join the trial?

4 criteria

  • Participants must be adults between the ages of 18 and 75 years old.
  • Participants must have a diagnosis of non-infectious uveitis. This includes types like intermediate uveitis, posterior uveitis, or panuveitis. Uveitis is an inflammation inside the eye.
  • Participants must have active uveitic disease in at least one eye. This means the inflammation is currently present.
  • Participants must weigh more than 40 kilograms (about 88 pounds) and have a body mass index (BMI) of 40 or less. BMI is a measure that uses height and weight to estimate body fat.

Who cannot join the trial?

9 criteria

  • Patients with any other eye condition that could interfere with the study results.
  • Patients who have had recent eye surgery or plan to have eye surgery during the study.
  • Patients who are currently using medications that could affect the study results.
  • Patients with a history of severe allergic reactions to medications.
  • Patients with any other serious health condition that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

Brepocitinib is an oral medication being studied for its effectiveness and safety in treating adults with active, non-infectious uveitis. Uveitis is an inflammation of the middle layer of the eye, and this study focuses on intermediate, posterior, and panuveitis types. The goal is to see how well brepocitinib can reduce inflammation and improve symptoms in these patients.

What is already known about the treatment

Brepocitinib – Brepocitinib is administered orally and is currently being studied in a Phase 3 clinical trial to assess its safety and effectiveness. It is primarily being investigated for the treatment of active non-infectious uveitis, including intermediate uveitis, posterior uveitis, and panuveitis. The medication works by inhibiting specific enzymes involved in the inflammatory process, thereby reducing inflammation at the molecular level. Brepocitinib is classified as a Janus kinase (JAK) inhibitor, which is a type of medication that targets pathways involved in immune responses.

Investigated diseases

  • Non-infectious Intermediate Uveitis

    This is an inflammation of the middle layer of the eye, specifically affecting the area between the iris and the choroid. It can cause symptoms such as blurred vision, floaters, and eye pain. The inflammation can lead to complications like cataracts or glaucoma if not managed. The condition can be chronic, with periods of flare-ups and remissions.

  • Non-infectious Posterior Uveitis

    This form of uveitis affects the back part of the eye, including the retina and choroid. It can result in symptoms like vision loss, floaters, and eye redness. The inflammation can cause damage to the retina, potentially leading to vision impairment. It often requires careful monitoring due to its potential impact on vision.

  • Non-infectious Panuveitis

    This is a type of uveitis where inflammation occurs throughout the entire uveal tract, affecting the front, middle, and back of the eye. Symptoms may include eye pain, redness, blurred vision, and sensitivity to light. The widespread inflammation can lead to complications affecting the entire eye structure. It is a complex condition that can vary in severity and duration.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515089-15-00Protocol codePVT-2201-303Estimated enrolment150 patientsSponsorPriovant Therapeutics Inc.

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