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

NCT ID: NCT05523765

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2024-07-30

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).

Detailed Description

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Conditions

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Non-infectious Intermediate Uveitis Non-infectious Posterior Uveitis Non-infectious Pan Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Brepocitinib Dose Level 1 by mouth (PO) once daily (QD)

Group Type EXPERIMENTAL

Brepocitinib

Intervention Type DRUG

Oral Brepocitinib

Brepocitinib Dose Level 2 by mouth (PO) once daily (QD)

Group Type EXPERIMENTAL

Brepocitinib

Intervention Type DRUG

Oral Brepocitinib

Interventions

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Brepocitinib

Oral Brepocitinib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Priovant Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brendan Johnson, PhD

Role: STUDY_DIRECTOR

SVP, Early Development

Locations

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Clinical Trial Site

Los Angeles, California, United States

Site Status

Clinical Trial Site

Palo Alto, California, United States

Site Status

Clinical Trial Site

Pasadena, California, United States

Site Status

Clinical Trial Site

Lakewood, Colorado, United States

Site Status

Clinical Trial Site

Waltham, Massachusetts, United States

Site Status

Clinical Trial Site

St Louis, Missouri, United States

Site Status

Clinical Trial Site

Palisades Park, New Jersey, United States

Site Status

Clinical Trial Site

Durham, North Carolina, United States

Site Status

Clinical Trial Site

Winston-Salem, North Carolina, United States

Site Status

Clinical Trial Site

Eugene, Oregon, United States

Site Status

Clinical Trial Site

Nashville, Tennessee, United States

Site Status

Clinical Trial Site

Bellaire, Texas, United States

Site Status

Clinical Trial Site

Katy, Texas, United States

Site Status

Clinical Trial Site

Plano, Texas, United States

Site Status

Clinical Trial Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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PVT-2201-201

Identifier Type: -

Identifier Source: org_study_id

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