A Phase 3 Study of Brepocitinib in Adults with Active, Non-Infectious, Non-Anterior Uveitis- CLARITY
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis
IRAS ID
1010875
Contact name
Casandra Kigundu
Contact email
Sponsor organisation
Priovant Therapeutics, Inc.
Eudract number
2024-515089-15
Clinicaltrials.gov Identifier
Research summary
Non-infectious intermediate-, posterior-, or pan-uveitis (NIU) is a serious eye condition that can happen on its own or alongside other inflammatory diseases. Brepocitinib is a new oral medication being studied for treating NIU, which can lead to vision loss if not managed properly. Current treatments often involve steroids, which can have serious side effects if used for too long. This study is exploring whether brepocitinib could be a safer option for controlling NIU and reducing the need for steroids. Brepocitinib has not yet been approved in the United Kingdom (UK) by the regulatory authorities to be used for NIU and its use is being allowed for research purposes only.
Results from previous studies showed that brepocitinib was generally safe and well tolerated. This study is being done to determine how safe and effective brepocitinib is and if it works to help decrease the inflammation associated with NIU. The study will also monitor the long-term safety of brepocitinib when taken for a period up to 96 weeks.
In this study, brepocitinib will be compared to a placebo. The placebo is a tablet that looks exactly like the study medicine but does not contain any active ingredient. Researchers will compare the results of taking the placebo to the results of taking the study medicine to see if there are any differences. It is not currently known if brepocitinib is more effective than placebo for NIU disease.
About 300 people will participate in this study at approximately 100 different study sites globally in Asia, Australia, Europe, Middle East, North America, and South America.
Subject's participation in this study is expected to last for up to 104 weeks (about 24 months).REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0249
Date of REC Opinion
2 Dec 2024
REC opinion
Further Information Favourable Opinion