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

Last updated: November 25, 2024
Sponsor: Priovant Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Uveitis

Treatment

Placebo PO QD

Brepocitinib PO QD

Brepocitinib 45 mg PO QD

Clinical Study ID

NCT06431373
PVT-2201-303
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult subjects (18-75 years old)

  • Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, orpanuveitis)

  • Active uveitic disease in at least 1 eye

  • Weight > 40 kg with a body mass index ≤ 40 kg/m2

Exclusion

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 situof 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

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Placebo PO QD
Phase: 3
Study Start date:
September 11, 2024
Estimated Completion Date:
February 01, 2028

Connect with a study center

  • Clinical Trial Site

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Clinical Trial Site

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Clinical Trial Site

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Clinical Trial Site

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Clinical Trial Site

    Irvine, California 92697
    United States

    Active - Recruiting

  • Clinical Trial Site

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Clinical Trial Site

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Clinical Trial Site

    Modesto, California 95356
    United States

    Active - Recruiting

  • Clinical Trial Site

    Sacramento, California 92825
    United States

    Active - Recruiting

  • Clinical Trial Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Clinical Trial Site

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Clinical Trial Site

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Clinical Trial Site

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Clinical Trial Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Clinical Trial Site

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • Clinical Trial Site

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Clinical Trial Site

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Clinical Trial Site

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Clinical Trial Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Clinical Trial Site

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Clinical Trial Site

    Omaha, Nebraska 68105
    United States

    Active - Recruiting

  • Clinical Trial Site

    Palisades Park, New Jersey 07650
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10017
    United States

    Active - Recruiting

  • Clinical Trial Site

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Clinical Trial Site

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Clinical Trial Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Clinical Trial Site

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Clinical Trial Site

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Clinical Trial Site

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Clinical Trial Site

    Austin, Texas 78712
    United States

    Active - Recruiting

  • Clinical Trial Site

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Clinical Trial Site

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Clinical Trial Site

    Houston, Texas 77025
    United States

    Active - Recruiting

  • Clinical Trial Site

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Clinical Trial Site

    Plano, Texas 75075
    United States

    Active - Recruiting

  • Clinical Trial Site

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Clinical Trial Site

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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