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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06431373

Acronym

CLARITY

Enrollment

371

Registered

2024-05-28

Start date

2024-09-11

Completion date

2028-02-01

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveitis, Uveitis, Intermediate, Uveitis, Posterior

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).

Interventions

DRUGBrepocitinib PO QD

Brepocitinib PO QD

DRUGPlacebo PO QD

Placebo PO QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48	48 weeks

Secondary

Measure	Time frame
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

Countries

Argentina, Australia, Austria, Belgium, Czechia, Germany, Greece, Hungary, Israel, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026