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

Phase 3

Recruiting

• Conditions: Uveitis, Intermediate; Uveitis; Uveitis, Posterior
• Interventions: Drug: Placebo PO QD; Drug: Brepocitinib PO QD

• Registration Number: NCT06431373
• Lead Sponsor: Priovant Therapeutics, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-28
• Study Start: 2024-09-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-09-11
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo PO QD	-
Arm 1	Brepocitinib PO QD	-

Primary Outcome Measures

Name	Time	Method
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48	48 weeks

Secondary Outcome Measures

Name	Time	Method
Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48	48 Weeks
Change in central subfleld thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24	24 weeks
Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24	24 weeks
Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24	24 weeks
Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48	48 weeks

Trial Locations

Locations (2)

Clinical Trial Site; 🇺🇸 Madison, Wisconsin, United States

NYU Langone Health; 🇺🇸 New York, New York, United States