Chorioretinitis Trials in Disease

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

This clinical trial is investigating a new treatment approach for people with non-infectious uveitis, a condition that causes inflammation inside the eye without being caused by an infection. The study focuses on three specific types: intermediate uveitis, posterior uveitis, and panuveitis. These conditions can affect different parts of the eye and may cause symptoms such as blurred vision, floaters, eye pain, and sensitivity to light.

Main inclusion criteria:

• Adults between 18 and 75 years of age
• Confirmed diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis
• Active inflammation present in at least one eye at the time of joining the study
• Body weight greater than 40 kilograms (about 88 pounds) and a body mass index of 40 or less

Main exclusion criteria:

• Presence of other eye conditions that could interfere with study results
• Recent eye surgery or plans for eye surgery during the study period
• Current use of medications that might affect study outcomes
• History of severe allergic reactions to medications
• Other serious health conditions that could interfere with the study
• Pregnancy or breastfeeding
• Participation in another clinical trial
• History of drug or alcohol abuse
• Inability to follow study procedures or attend required visits

Focus and goal of the trial:

The main purpose of this study is to evaluate how effective brepocitinib is in reducing inflammation and improving symptoms in people with active non-infectious uveitis. The trial uses a randomized approach, meaning participants will be assigned by chance to receive either brepocitinib or a placebo tablet that looks identical but contains no active medication. This helps researchers determine whether any improvements are truly due to the medication.

The study follows participants for up to 96 weeks, with regular check-ups to monitor their condition. Researchers will specifically measure the time it takes for treatment failure to occur between Week 6 and Week 48. They will also track other important factors such as changes in visual acuity (how clearly you can see) and changes in the thickness of the central part of the retina. Throughout the trial, doctors will carefully observe participants to ensure their safety and to gather information about how well the treatment works.

Investigational drug:

The medication being tested is called brepocitinib, which is taken orally as a tablet. Brepocitinib belongs to a class of medications known as Janus kinase (JAK) inhibitors. These drugs work by blocking specific enzymes involved in the inflammatory process, which helps reduce inflammation at the cellular level. In this study, brepocitinib is being used alongside prednisone, a corticosteroid medication that is commonly used to treat inflammation. The study also uses a placebo tablet to match the appearance of the brepocitinib tablet for comparison purposes.

This is a Phase 3 clinical trial, which means it represents an advanced stage of testing where the medication has already shown promise in earlier studies. The trial aims to provide more detailed information about both the effectiveness and safety of brepocitinib for treating non-infectious uveitis. Recruitment for the study is expected to begin in February 2025, and the trial is scheduled to conclude by February 2028.