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

NCT06431373 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PVT-2201-303
• Study Type: interventional
• Target: 371
• Locations: 12 countries
• Sites: 104

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).

Conditions

Uveitis; Uveitis, Posterior; Uveitis, Intermediate

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48

  48 weeks

Secondary Outcomes (5)

• 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 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 48

  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

  48 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Brepocitinib PO QD

Arm 2

PLACEBO COMPARATOR

Drug: Placebo PO QD

Interventions

Brepocitinib PO QD DRUG

Brepocitinib PO QD

Arm 1

Placebo PO QD DRUG

Placebo PO QD

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Has confirmed or suspected current diagnosis of infectious uveitis History of or have:
• Lymphoproliferative disorder
• active malignancy
• 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.)
• thrombosis or cerebrovascular ischemic event disease within the last 12 months
• a high risk for herpes zoster reactivation
• active or recent infections

Sponsors & Collaborators

• Priovant Therapeutics, Inc.: lead

Study Sites (107)

Clinical Trial Site

Phoenix, Arizona, 85020, United States

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Phoenix, Arizona, 85054, United States

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Bakersfield, California, 93309, United States

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Beverly Hills, California, 90211, United States

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Fullerton, California, 92835, United States

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Irvine, California, 92697, United States

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La Jolla, California, 92093, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90095, United States

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Modesto, California, 95356, United States

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Sacramento, California, 92825, United States

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Aurora, Colorado, 80045, United States

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Denver, Colorado, 80246, United States

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Fort Lauderdale, Florida, 33308, United States

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St. Petersburg, Florida, 33711, United States

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Chicago, Illinois, 60637, United States

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Oak Park, Illinois, 60304, United States

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Carmel, Indiana, 46290, United States

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Prairie Village, Kansas, 66208, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02114, United States

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Waltham, Massachusetts, 02451, United States

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Ann Arbor, Michigan, 48105, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63108, United States

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Omaha, Nebraska, 68105, United States

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Palisades Park, New Jersey, 07650, United States

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NYU Langone Health

New York, New York, 10017, United States

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Rochester, New York, 14642, United States

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Durham, North Carolina, 27705, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43212, United States

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Portland, Oregon, 97221, United States

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Portland, Oregon, 97239, United States

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Erie, Pennsylvania, 16507, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19141, United States

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Greenville, South Carolina, 29605, United States

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Nashville, Tennessee, 37232, United States

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Austin, Texas, 78712, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77025, United States

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Katy, Texas, 77494, United States

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Plano, Texas, 75075, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78230, United States

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Madison, Wisconsin, 53705, United States

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Rosario, Santa Fe Province, 41076, Argentina

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Buenos Aires, 41076, Argentina

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Buenos Aires, C1015, Argentina

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Buenos Aires, C1061AAE, Argentina

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Buenos Aires, C1121, Argentina

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Sydney, New South Wales, 2000, Australia

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East Melbourne, Victoria, 3002, Australia

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Nedlands, Western Australia, 6009, Australia

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Linz, 04020, Austria

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Leuven, VI-Brabant, 3000, Belgium

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Prague, 128 08, Czechia

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Bonn, North Rhine-Westphalia, 53127, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Münster, North Rhine-Westphalia, 48145, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Kiel, 24105, Germany

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Mainz, 55131, Germany

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Thessaloniki, 54622, Greece

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Pécs, Baranya, 07623, Hungary

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Debrecen, Hajdú-Bihar, 04032, Hungary

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Budapest, Pest County, 01085, Hungary

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Budapest, 01133, Hungary

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Ashkelon, 7830604, Israel

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Haifa, 3109601, Israel

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Haifa, 3434104, Israel

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Holon, 58101, Israel

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Jerusalem, 9013102, Israel

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Jerusalem, 9112001, Israel

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Kfar Saba, 4428164, Israel

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Poria – Neve Oved, 1528801, Israel

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Tel Aviv, 6423906, Israel

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Tel Aviv, 69710, Israel

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Perugia, Umbria, 06129, Italy

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Milan, Italy

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Reggio Emilia, 42123, Italy

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Roma, 00184, Italy

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Barcelona, Catalonia, 08035, Spain

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Barcelona, 08028, Spain

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Madrid, 28-046, Spain

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Madrid, 28040, Spain

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Valladolid, 47011, Spain

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London, England, EC1V 2PD, United Kingdom

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London, England, SE1 7EH, United Kingdom

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Maidstone, Kent, ME169QQ, United Kingdom

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Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

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Oxford, Oxfordshire, OX3 9DU, United Kingdom

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Sheffield, South Yorkshire, S10 2JF, United Kingdom

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Birmingham, West Midlands, B18 7QH, United Kingdom

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Bradford, Yorkshire, BD9 6TB, United Kingdom

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Birmingham, B1S 2GW, United Kingdom

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Bristol, BS1 2LX, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Related Links

• Related Info

MeSH Terms

Conditions

Uveitis, Posterior; Uveitis, Intermediate; Uveitis

Condition Hierarchy (Ancestors)

Panuveitis; Uveal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 28, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

IL (10); AR (5); HU (4); BE (1); CZ (1); GR (1); IT (4); US (53); GB (12); ES (5); AU (1); DE (7)