Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis
Conditions
Keywords
Brepocitinib, PF-06700841, uveitis, NIU
Brief summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).
Interventions
DRUGBrepocitinib
Oral Brepocitinib
Sponsors
Priovant Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Screening up to 28 days after the last dose of study drug at 52 weeks | Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs, laboratory evaluation for hematology, blood chemistry, and urinalysis; vital signs; electrocardiograms (ECGs); and physical examinations. The investigator will determine whether the change is clinically meaningful. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24 | 24 weeks |
Countries
United States
Outcome results
None listed