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

Non-infectious Intermediate Uveitis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05523765
• Other study ID #: PVT-2201-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 14, 2022
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Priovant Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-infectious Intermediate Uveitis
• Non-infectious Posterior Uveitis
• Panuveitis
• Uveitis
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

Drug:
• Brepocitinib
Oral Brepocitinib

Locations

Country	Name	City	State
United States	Clinical Trial Site	Bellaire	Texas
United States	Clinical Trial Site	Durham	North Carolina
United States	Clinical Trial Site	Eugene	Oregon
United States	Clinical Trial Site	Katy	Texas
United States	Clinical Trial Site	Lakewood	Colorado
United States	Clinical Trial Site	Los Angeles	California
United States	Clinical Trial Site	Nashville	Tennessee
United States	Clinical Trial Site	Palisades Park	New Jersey
United States	Clinical Trial Site	Palo Alto	California
United States	Clinical Trial Site	Pasadena	California
United States	Clinical Trial Site	Plano	Texas
United States	Clinical Trial Site	Saint Louis	Missouri
United States	Clinical Trial Site	Salt Lake City	Utah
United States	Clinical Trial Site	Waltham	Massachusetts
United States	Clinical Trial Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Priovant Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24		24 weeks

External Links

•   Study Website