search
Back to results

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

Primary Purpose

Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brepocitinib
Sponsored by
Priovant Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-infectious Intermediate Uveitis focused on measuring Brepocitinib, PF-06700841, uveitis, NIU

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ongoing (or initiated during screening) therapy with oral prednisone
  5. Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy
  6. 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 a 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

Sites / Locations

  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Brepocitinib Dose Level 1 PO QD

Brepocitinib Dose Level 2 PO QD

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2022
Last Updated
July 17, 2023
Sponsor
Priovant Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05523765
Brief Title
A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis
Acronym
NEPTUNE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Priovant Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis
Keywords
Brepocitinib, PF-06700841, uveitis, NIU

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brepocitinib Dose Level 1 PO QD
Arm Type
Experimental
Arm Title
Brepocitinib Dose Level 2 PO QD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brepocitinib
Intervention Description
Oral Brepocitinib
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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 Outcome Measure Information:
Title
Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Johnson, PhD
Organizational Affiliation
SVP, Early Development
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Clinical Trial Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Clinical Trial Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Clinical Trial Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Clinical Trial Site
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Clinical Trial Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Trial Site
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Facility Name
Clinical Trial Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Clinical Trial Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Clinical Trial Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Clinical Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Clinical Trial Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Clinical Trial Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Clinical Trial Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Clinical Trial Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.neptunestudy.com
Description
Study Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs