CompletedPhase 2

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

United States26 participantsStarted 2022-11-14

Plain-language summary

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).

Who can participate

Age range18 Years – 74 Years

SexALL

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Inclusion criteria

✓. Adult subjects (18-74 years old)
✓. Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
✓. Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator:
✓. Active, inflammatory chorioretinal and/or retinal vascular lesion; OR
✓. ≥2+ vitreous haze grade (NEI/SUN criteria).
✓. Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy
✓. Weight \> 40 kg with a body mass index \< 40 kg/m2.

Exclusion criteria

✕. Has isolated anterior uveitis.
✕. Has confirmed or suspected current diagnosis of infectious uveitis
✕. History of:
✕. At risk of thrombosis and cardiovascular disease
✕. Have a high risk for herpes zoster reactivation
✕. Have active or recent infections

What they're measuring

Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Screening up to 28 days after the last dose of study drug at 52 weeks

Trial details

NCT IDNCT05523765

SponsorPriovant Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-30

View on ClinicalTrials.gov More Non-infectious Intermediate Uveitis trials