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NCT Number: NCT05523765

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

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

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Key information

Conditions

Non-infectious Intermediate Uveitis Eye Diseases Non-infectious Pan Uveitis Non-infectious Posterior Uveitis Uveal Diseases Uveitis

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site, Los Angeles, California, United States

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 (18-74 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:
  • Any lymphoproliferative disorder
  • Active malignancy;
  • History of 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.)
  • At risk of thrombosis and cardiovascular disease
  • Have a high risk for herpes zoster reactivation
  • Have active or recent infections

Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

Brepocitinib

Drug

Oral Brepocitinib

Primary outcomes

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

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

    Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs, laboratory evaluation for hematology, blood chemistry, and urinalysis; vital signs; electrocardiograms (ECGs); and physical examinations. The investigator will determine whether the change is clinically meaningful.

Secondary outcomes

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

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Priovant Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-Masked, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active Non-Infectious Intermediate-, Posterior-, and Panuveitis

Acronym: NEPTUNE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2022
Registry last updated
Jul 25, 2025

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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