A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis (CLARITY)

Priovant Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Uveitis; Uveitis, Intermediate; Uveitis, Posterior

Treatments: Drug: Placebo PO QD; Drug: Brepocitinib PO QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT06431373

PVT-2201-303

Details and patient eligibility

About

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

Enrollment: 371 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects (18-75 years old)
• Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
• Active uveitic disease in at least 1 eye
• Weight > 40 kg with a body mass index ≤ 40 kg/m2

Exclusion criteria

Has confirmed or suspected current diagnosis of infectious uveitis History of or have:

1. Lymphoproliferative 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 or cerebrovascular ischemic event disease within the last 12 months
5. a high risk for herpes zoster reactivation
6. active or recent infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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371 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Brepocitinib PO QD

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo PO QD