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

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

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

Study Overview

• Status: Completed
• Conditions: Non-infectious Intermediate Uveitis; Non-infectious Posterior Uveitis; Non-infectious Pan Uveitis
• Intervention / Treatment: Drug: Brepocitinib

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Clinical Trial Site
    • Palo Alto, California, United States, 94303
      • Clinical Trial Site
    • Pasadena, California, United States, 91107
      • Clinical Trial Site
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Clinical Trial Site
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Clinical Trial Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Clinical Trial Site
  • New Jersey
    • Palisades Park, New Jersey, United States, 07650
      • Clinical Trial Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Clinical Trial Site
    • Winston-Salem, North Carolina, United States, 27157
      • Clinical Trial Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Clinical Trial Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Trial Site
  • Texas
    • Bellaire, Texas, United States, 77401
      • Clinical Trial Site
    • Katy, Texas, United States, 77494
      • Clinical Trial Site
    • Plano, Texas, United States, 75075
      • Clinical Trial Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult subjects (18-74 years old)
2. Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).

3. 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:

   1. Active, inflammatory chorioretinal and/or retinal vascular lesion; OR
   2. ≥2+ vitreous haze grade (NEI/SUN criteria).
4. Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy
5. Weight > 40 kg with a body mass index < 40 kg/m2.

Exclusion Criteria:

1. Has isolated anterior uveitis.
2. Has confirmed or suspected current diagnosis of infectious uveitis

3. 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.)
4. At risk of thrombosis and cardiovascular disease
5. Have a high risk for herpes zoster reactivation
6. Have active or recent infections

Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brepocitinib Dose Level 1 by mouth (PO) once daily (QD)	Drug: Brepocitinib; Oral Brepocitinib
Experimental: Brepocitinib Dose Level 2 by mouth (PO) once daily (QD)	Drug: Brepocitinib; Oral Brepocitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.	Screening up to 28 days after the last dose of study drug at 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24	24 weeks

Collaborators and Investigators

• Sponsor: Priovant Therapeutics, Inc.
• Investigators: Study Director: Brendan Johnson, PhD, SVP, Early Development

Publications and helpful links

Helpful Links

• Study Website

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: PF-06700841; uveitis; Brepocitinib; NIU
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Choroiditis; Choroid Diseases; Uveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Panuveitis
• Other Study ID Numbers: PVT-2201-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Priovant Therapeutics will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) from eligible studies upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Data requests will be reviewed and approved on the basis of scientific merit.
• IPD Sharing Time Frame: The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
• IPD Sharing Access Criteria: Access will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). Further details on Priovant Therapeutics' data sharing criteria and process for requesting access can be obtained by emailing info@priovanttx.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No