A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis

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

Official Title
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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

Conditions
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Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis

Intervention / Treatment
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* Drug: Brepocitinib


Participation Criteria
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Eligibility Criteria
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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). Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy Weight > 40 kg with a body mass index < 40 kg/m2. Exclusion Criteria: Has isolated anterior uveitis. Has confirmed or suspected current diagnosis of infectious uveitis 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.) At risk of thrombosis and cardiovascular disease Have a high risk for herpes zoster reactivation Have active or recent infections Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brepocitinib Dose Level 1 PO QD<br> | Drug: Brepocitinib<br>* Oral Brepocitinib<br>|
| Experimental: Brepocitinib Dose Level 2 PO QD<br> | Drug: Brepocitinib<br>* Oral Brepocitinib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | Screening up to 28 days after the last dose of study drug at 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24 |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brepocitinib, PF-06700841, uveitis, NIU