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

PVT-2201-303

The purpose of this study is to determine the safety and efficacy (including corticosteroid-sparing effect) of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

2024-08-23

2026-08-23

2027-08-23

Not yet recruiting

Early phase I

220

Inclusion Criteria: * Adult subjects (18-74 years old) * Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis). * Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator: Active, inflammatory chorioretinal and/or retinal vascular lesion; OR ≥2+ vitreous haze grade (NEI/SUN criteria). * Weight \> 40 kg with a body mass index \< 40 kg/m2. Exclusion Criteria: * Has isolated anterior uveitis. * Has macular edema as the only sign of intermediate uveitis, posterior uveitis, or panuveitis. * Has confirmed or suspected current diagnosis of infectious uveitis * History of or have: 1. ymphoproliferative 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 and cardiovascular disease within the last 12 months 5. a high risk for herpes zoster reactivation 6. active or recent infections

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 220, 'type': 'ESTIMATED'}}

2024-05-31