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

January 8, 2026 updated by: Priovant Therapeutics, Inc.

A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 41076
        • Clinical Trial Site
      • Buenos Aires, Argentina, C1015
        • Clinical Trial Site
      • Buenos Aires, Argentina, C1061AAE
        • Clinical Trial Site
      • Buenos Aires, Argentina, C1121
        • Clinical Trial Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 41076
        • Clinical Trial Site
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Clinical Trial Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Clinical Trial Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Clinical Trial Site
  • Austria
      • Linz, Austria, 04020
        • Clinical Trial Site
  • Belgium
    • VI-Brabant
      • Leuven, VI-Brabant, Belgium, 3000
        • Clinical Trial Site
  • Czechia
      • Prague, Czechia, 128 08
        • Clinical Trial Site
  • Germany
      • Kiel, Germany, 24105
        • Clinical Trial Site
      • Mainz, Germany, 55131
        • Clinical Trial Site
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Clinical Trial Site
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Clinical Trial Site
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Clinical Trial Site
      • Münster, North Rhine-Westphalia, Germany, 48145
        • Clinical Trial Site
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Clinical Trial Site
  • Greece
      • Thessaloniki, Greece, 54622
        • Clinical Trial Site
  • Hungary
      • Budapest, Hungary, 01133
        • Clinical Trial Site
    • Baranya
      • Pécs, Baranya, Hungary, 07623
        • Clinical Trial Site
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 04032
        • Clinical Trial Site
    • Pest County
      • Budapest, Pest County, Hungary, 01085
        • Clinical Trial Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Clinical Trial Site
      • Haifa, Israel, 3109601
        • Clinical Trial Site
      • Haifa, Israel, 3434104
        • Clinical Trial Site
      • Holon, Israel, 58101
        • Clinical Trial Site
      • Jerusalem, Israel, 9112001
        • Clinical Trial Site
      • Jerusalem, Israel, 9013102
        • Clinical Trial Site
      • Kfar Saba, Israel, 4428164
        • Clinical Trial Site
      • Poria – Neve Oved, Israel, 1528801
        • Clinical Trial Site
      • Tel Aviv, Israel, 6423906
        • Clinical Trial Site
      • Tel Aviv, Israel, 69710
        • Clinical Trial Site
  • Italy
      • Milan, Italy
        • Clinical Trial Site
      • Reggio Emilia, Italy, 42123
        • Clinical Trial Site
      • Roma, Italy, 00184
        • Clinical Trial Site
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Clinical Trial Site
  • Spain
      • Barcelona, Spain, 08028
        • Clinical Trial Site
      • Madrid, Spain, 28040
        • Clinical Trial Site
      • Madrid, Spain, 28-046
        • Clinical Trial Site
      • Valladolid, Spain, 47011
        • Clinical Trial Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Clinical Trial Site
  • United Kingdom
      • Birmingham, United Kingdom, B1S 2GW
        • Clinical Trial Site
      • Bristol, United Kingdom, BS1 2LX
        • Clinical Trial Site
      • Liverpool, United Kingdom, L7 8XP
        • Clinical Trial Site
      • Manchester, United Kingdom, M13 9WL
        • Clinical Trial Site
    • England
      • London, England, United Kingdom, EC1V 2PD
        • Clinical Trial Site
      • London, England, United Kingdom, SE1 7EH
        • Clinical Trial Site
    • Kent
      • Maidstone, Kent, United Kingdom, ME169QQ
        • Clinical Trial Site
    • North Yorkshire
      • Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
        • Clinical Trial Site
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Clinical Trial Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Clinical Trial Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • Clinical Trial Site
    • Yorkshire
      • Bradford, Yorkshire, United Kingdom, BD9 6TB
        • Clinical Trial Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Clinical Trial Site
      • Phoenix, Arizona, United States, 85020
        • Clinical Trial Site
    • California
      • Bakersfield, California, United States, 93309
        • Clinical Trial Site
      • Beverly Hills, California, United States, 90211
        • Clinical Trial Site
      • Fullerton, California, United States, 92835
        • Clinical Trial Site
      • Irvine, California, United States, 92697
        • Clinical Trial Site
      • La Jolla, California, United States, 92093
        • Clinical Trial Site
      • Los Angeles, California, United States, 90033
        • Clinical Trial Site
      • Los Angeles, California, United States, 90095
        • Clinical Trial Site
      • Modesto, California, United States, 95356
        • Clinical Trial Site
      • Sacramento, California, United States, 92825
        • Clinical Trial Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Clinical Trial Site
      • Denver, Colorado, United States, 80246
        • Clinical Trial Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Clinical Trial Site
      • St. Petersburg, Florida, United States, 33711
        • Clinical Trial Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Clinical Trial Site
      • Oak Park, Illinois, United States, 60304
        • Clinical Trial Site
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Clinical Trial Site
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Clinical Trial Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Clinical Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Trial Site
      • Waltham, Massachusetts, United States, 02451
        • Clinical Trial Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Clinical Trial Site
      • Detroit, Michigan, United States, 48201
        • Clinical Trial Site
      • Detroit, Michigan, United States, 48202
        • Clinical Trial Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Trial Site
      • Rochester, Minnesota, United States, 55905
        • Clinical Trial Site
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Clinical Trial Site
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Clinical Trial Site
    • New Jersey
      • Palisades Park, New Jersey, United States, 07650
        • Clinical Trial Site
    • New York
      • New York, New York, United States, 10017
        • NYU Langone Health
      • Rochester, New York, United States, 14642
        • Clinical Trial Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Clinical Trial Site
      • Winston-Salem, North Carolina, United States, 27157
        • Clinical Trial Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Clinical Trial Site
      • Cleveland, Ohio, United States, 44106
        • Clinical Trial Site
      • Columbus, Ohio, United States, 43212
        • Clinical Trial Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Clinical Trial Site
      • Portland, Oregon, United States, 97221
        • Clinical Trial Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Clinical Trial Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Clinical Trial Site
      • Philadelphia, Pennsylvania, United States, 19141
        • Clinical Trial Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Clinical Trial Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Clinical Trial Site
    • Texas
      • Austin, Texas, United States, 78712
        • Clinical Trial Site
      • Bellaire, Texas, United States, 77401
        • Clinical Trial Site
      • Dallas, Texas, United States, 75390
        • Clinical Trial Site
      • Houston, Texas, United States, 77025
        • Clinical Trial Site
      • Katy, Texas, United States, 77494
        • Clinical Trial Site
      • Plano, Texas, United States, 75075
        • Clinical Trial Site
      • Round Rock, Texas, United States, 78681
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78230
        • Clinical Trial Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Brepocitinib PO QD
Brepocitinib PO QD
Placebo Comparator: Arm 2
Drug: Placebo PO QD
Placebo PO QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24
Time Frame: 24 weeks
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
Time Frame: 24 weeks
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 48
Time Frame: 48 Weeks
48 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
Time Frame: 48 weeks
48 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 24
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Priovant Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2024

Primary Completion (Estimated)

September 11, 2026

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT-2201-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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