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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05523765
Recruitment Status : Recruiting
First Posted : August 31, 2022
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Priovant Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Non-infectious Intermediate Uveitis Non-infectious Posterior Uveitis Non-infectious Pan Uveitis Drug: Brepocitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : November 14, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024


Arm Intervention/treatment
Experimental: Brepocitinib Dose Level 1 PO QD Drug: Brepocitinib
Oral Brepocitinib

Experimental: Brepocitinib Dose Level 2 PO QD Drug: Brepocitinib
Oral Brepocitinib




Primary Outcome Measures :
  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 Outcome Measures :
  1. Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24 [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05523765


Contacts
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Contact: Clinical Trial Administrator (212) 634-9743 NeptuneStudyManager@priovanttx.com

Locations
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United States, California
Clinical Trial Site Recruiting
Los Angeles, California, United States, 90095
Clinical Trial Site Recruiting
Palo Alto, California, United States, 94303
Clinical Trial Site Recruiting
Pasadena, California, United States, 91107
United States, Colorado
Clinical Trial Site Recruiting
Lakewood, Colorado, United States, 80228
United States, Massachusetts
Clinical Trial Site Recruiting
Waltham, Massachusetts, United States, 02451
United States, Missouri
Clinical Trial Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Clinical Trial Site Not yet recruiting
Omaha, Nebraska, United States, 68105
United States, New Jersey
Clinical Trial Site Recruiting
Palisades Park, New Jersey, United States, 07650
United States, North Carolina
Clinical Trial Site Recruiting
Durham, North Carolina, United States, 27710
Clinical Trial Site Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Clinical Trial Site Recruiting
Eugene, Oregon, United States, 97401
United States, Tennessee
Clinical Trial Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Clinical Trial Site Recruiting
Bellaire, Texas, United States, 77401
Clinical Trial Site Recruiting
Katy, Texas, United States, 77494
Clinical Trial Site Recruiting
Plano, Texas, United States, 75075
United States, Utah
Clinical Trial Site Recruiting
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Priovant Therapeutics, Inc.
Investigators
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Study Director: Brendan Johnson, PhD SVP, Early Development
Additional Information:
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Responsible Party: Priovant Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05523765    
Other Study ID Numbers: PVT-2201-201
First Posted: August 31, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Priovant Therapeutics, Inc.:
Brepocitinib
PF-06700841
uveitis
NIU
Additional relevant MeSH terms:
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Uveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Panuveitis
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases