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
1 other identifier
interventional
26
1 country
15
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2022
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedStudy Start
First participant enrolled
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedJuly 25, 2025
July 1, 2025
1.7 years
August 25, 2022
July 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24
24 weeks
Study Arms (2)
Brepocitinib Dose Level 1 by mouth (PO) once daily (QD)
EXPERIMENTALBrepocitinib Dose Level 2 by mouth (PO) once daily (QD)
EXPERIMENTALInterventions
Oral Brepocitinib
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Clinical Trial Site
Los Angeles, California, 90095, United States
Clinical Trial Site
Palo Alto, California, 94303, United States
Clinical Trial Site
Pasadena, California, 91107, United States
Clinical Trial Site
Lakewood, Colorado, 80228, United States
Clinical Trial Site
Waltham, Massachusetts, 02451, United States
Clinical Trial Site
St Louis, Missouri, 63110, United States
Clinical Trial Site
Palisades Park, New Jersey, 07650, United States
Clinical Trial Site
Durham, North Carolina, 27710, United States
Clinical Trial Site
Winston-Salem, North Carolina, 27157, United States
Clinical Trial Site
Eugene, Oregon, 97401, United States
Clinical Trial Site
Nashville, Tennessee, 37203, United States
Clinical Trial Site
Bellaire, Texas, 77401, United States
Clinical Trial Site
Katy, Texas, 77494, United States
Clinical Trial Site
Plano, Texas, 75075, United States
Clinical Trial Site
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brendan Johnson, PhD
SVP, Early Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2022
First Posted
August 31, 2022
Study Start
November 14, 2022
Primary Completion
July 30, 2024
Study Completion
July 30, 2024
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.