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

About

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).

Primary Purpose

Other

Study Type

Interventional

Phase

Phase II

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

74 Years

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

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