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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Medical University Of Vienna Vienna Austria
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Warszawski Szpital Okulistyczny Sp. z o.o. Warsaw Poland
Augenzentrum Am St Franziskus-Hospital Muenster Munster Germany
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Rome Italy
General University Hospital Of Larissa Larissa Greece
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Pecs Pecs Hungary
University Of Szeged Szeged Hungary
Pkvieqccvnfh Ceedlrn Mfvutlxz Sba z ozoe Gdansk Poland
Uhaxvwdrolbkkdunyycua Dxzilkqqrum Ans Duesseldorf Germany
Ubtaungpqgmcswcrezqrm Mmzjidaw Asp Munster Germany
Aycermh Uzr Ifcmt Dj Rwbvvy Ewxonh Reggio Emilia Italy
Jevhfjqo Kgwmgv Uwnnhuqqfy Linz Austria
Hpvtmots Vkeh dqievmcp Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.02.2025
Belgium Belgium
Not recruiting
01.02.2025
Czechia Czechia
Not recruiting
01.02.2025
Germany Germany
Not recruiting
01.02.2025
Greece Greece
Not recruiting
01.02.2025
Hungary Hungary
Not recruiting
01.02.2025
Italy Italy
Not recruiting
01.02.2025
Poland Poland
Not recruiting
01.02.2025
Spain Spain
Not recruiting
01.02.2025

Trial locations

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.

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 ID:
2024-515089-15-00
Protocol code:
PVT-2201-303
NCT ID:
NCT06431373
Trial Phase:
Therapeutic confirmatory (Phase III)

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