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CompletedNCT05523765NEPTUNEUpdated Jul 25, 2025

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

A Phase 2 interventional study of Brepocitinib in Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis and Non-infectious Pan Uveitis, sponsored by Priovant Therapeutics, Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Priovant Therapeutics, Inc. · Phase 2, Interventional, and Other

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Non-infectious Intermediate Uveitis
  • Non-infectious Posterior Uveitis
  • Non-infectious Pan Uveitis

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Keywords

  • Brepocitinib
  • PF-06700841
  • uveitis
  • NIU
03

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

04

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Brepocitinib Dose Level 1 by mouth (PO) once daily (QD)

    Drug: Brepocitinib

  • Experimental
    Brepocitinib Dose Level 2 by mouth (PO) once daily (QD)

    Drug: Brepocitinib

Interventions

  • DrugBrepocitinib

    Oral Brepocitinib

05

What researchers measure

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.

    Time frame: 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

    Time frame: 24 weeks

06

Study locations

15 sites
  • 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
07

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05523765
Lead sponsor
Priovant Therapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 31, 2022
Start date
Nov 14, 2022
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Last update
Jul 25, 2025

Study contacts

Brendan Johnson, PhD
study director · SVP, Early Development

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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