A Phase 2 Randomized, Double-Masked, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active Non-Infectious Intermediate-, Posterior-, and Panuveitis

PVT-2201-201

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).

2022-11-14

2024-07-01

2024-07-01

Active (not recruiting)

Early phase I

26

Inclusion Criteria: 1. Adult subjects (18-74 years old) 2. Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis). 3. 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: 1. Active, inflammatory chorioretinal and/or retinal vascular lesion; OR 2. ≥2+ vitreous haze grade (NEI/SUN criteria). 4. Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy 5. Weight \> 40 kg with a body mass index \< 40 kg/m2. Exclusion Criteria: 1. Has isolated anterior uveitis. 2. Has confirmed or suspected current diagnosis of infectious uveitis 3. History of: * Any lymphoproliferative disorder * Active malignancy; * History of 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. At risk of thrombosis and cardiovascular disease 5. Have a high risk for herpes zoster reactivation 6. Have active or recent infections Other protocol defined Inclusion/Exclusion criteria may apply

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

2023-07-19