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

Phase 2

Completed

• Conditions: Non-infectious Pan Uveitis; Non-infectious Intermediate Uveitis; Non-infectious Posterior Uveitis
• Interventions: Drug: Brepocitinib

• Registration Number: NCT05523765
• Lead Sponsor: Priovant Therapeutics, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-08-31
• Study Start: 2022-11-14
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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/Exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brepocitinib Dose Level 1 PO QD	Brepocitinib	-
Brepocitinib Dose Level 2 PO QD	Brepocitinib	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24	24 weeks

Trial Locations

Locations (1)

Clinical Trial Site; 🇺🇸 Salt Lake City, Utah, United States