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NCT Number: NCT06431373

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Uveitis, Posterior Eye Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Intermediate

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Trial Site, Rosario, Santa Fe Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Treatment and study plan

Brepocitinib PO QD

Drug

Brepocitinib PO QD

Placebo PO QD

Drug

Placebo PO QD

Primary outcomes

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

    Time frame: 48 weeks

Secondary outcomes

  1. Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24

    Time frame: 24 weeks

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Priovant Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: CLARITY

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
May 28, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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