CLARITYA 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
Brepocitinib PO QD
+ Placebo PO QD
Eye Diseases+3
+ Uveal Diseases
+ Uveitis
Treatment Study
Summary
Study start date: September 11, 2024
Actual date on which the first participant was enrolled.This study is focused on assessing how safe and effective the medicine brepocitinib is for adults with a specific eye condition called non-infectious uveitis, which affects the middle or back part of the eye. Uveitis can cause inflammation, leading to vision problems, and current treatment options may not be sufficient or suitable for everyone. By exploring brepocitinib, the study aims to find a better treatment option for those suffering from this condition, potentially improving their quality of life and addressing a significant unmet medical need. Participants in this study will receive brepocitinib orally, meaning they will take it by mouth. The trial involves comparing the effects of brepocitinib against a placebo, which is a substance with no active drug, to evaluate its effectiveness and safety. The researchers will closely monitor how the participants respond to the treatment to determine its impact on their uveitis symptoms. Although the primary outcomes are not listed, the overall goal is to see if brepocitinib can effectively reduce inflammation and improve vision without causing significant side effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.371 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Adult subjects (18-75 years old) * Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis) * Active uveitic disease in at least 1 eye * Weight \> 40 kg with a body mass index ≤ 40 kg/m2 Exclusion Criteria: Has confirmed or suspected current diagnosis of infectious uveitis History of or have: 1. Lymphoproliferative disorder 2. active malignancy 3. cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) 4. thrombosis or cerebrovascular ischemic event disease within the last 12 months 5. a high risk for herpes zoster reactivation 6. active or recent infections
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 107 locations
Clinical Trial Site
Holon, IsraelClinical Trial Site
Jerusalem, IsraelClinical Trial Site
Jerusalem, Israel