Clinical trial NCT06431373: A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis
Official title: A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Uveitis, Posterior
Uveitis, Intermediate
Uveitis
Lead sponsor: Priovant Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).


Eligibility criteria: Inclusion Criteria:

* Adult subjects (18-75 years old)
* Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
* Active uveitic disease in at least 1 eye
* Weight \> 40 kg with a body mass index ≤ 40 kg/m2

Exclusion Criteria:

Has confirmed or suspected current diagnosis of infectious uveitis History of or have:

1. Lymphoproliferative disorder
2. active malignancy
3. 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. thrombosis orand cerebrovascularardiovascular ischemic event disease within the last 12 months
5. a high risk for herpes zoster reactivation
6. active or recent infections

Primary outcomes:
measure: Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24
timeFrame: 24 weeks
measure: Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24
timeFrame: 24 weeks
measure: Change in central subfleld thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24
timeFrame: 24 weeks
measure: Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48
timeFrame: 48 Weeks
measure: Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Trial Site
state: Arizona
city: Bakersfield
country: United States
facility: Clinical Trial Site
state: California
city: Beverly Hills
country: United States
facility: Clinical Trial Site
state: California
city: Fullerton
country: United States
facility: Clinical Trial Site
state: California
city: Irvine
country: United States
facility: Clinical Trial Site
state: California
city: La Jolla
country: United States
facility: Clinical Trial Site
state: California
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Modesto
country: United States
facility: Clinical Trial Site
state: California
city: Sacramento
country: United States
facility: Clinical Trial Site
state: California
city: Aurora
country: United States
facility: Clinical Trial Site
state: Colorado
city: Fort Lauderdale
country: United States
facility: Clinical Trial Site
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Trial Site
state: Florida
city: Carmel
country: United States
facility: Clinical Trial Site
state: Indiana
city: Boston
country: United States
facility: Clinical Trial Site
state: Massachusetts
city: Waltham
country: United States
facility: Clinical Trial Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinical Trial Site
state: Michigan
city: Detroit
country: United States
facility: Clinical Trial Site
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Trial Site
state: Minnesota
city: Rochester
country: United States
facility: Clinical Trial Site
state: Minnesota
city: Saint Louis
country: United States
facility: Clinical Trial Site
state: Missouri
city: Omaha
country: United States
facility: Clinical Trial Site
state: Nebraska
city: Palisades Park
country: United States
facility: Clinical Trial Site
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Durham
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Cleveland
country: United States
facility: Clinical Trial Site
state: Ohio
city: Portland
country: United States
facility: Clinical Trial Site
state: Oregon
city: Portland
country: United States
facility: Clinical Trial Site
state: Oregon
city: Erie
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Trial Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Trial Site
state: Texas
city: Bellaire
country: United States
facility: Clinical Trial Site
state: Texas
city: Dallas
country: United States
facility: Clinical Trial Site
state: Texas
city: Houston
country: United States
facility: Clinical Trial Site
state: Texas
city: Katy
country: United States
facility: Clinical Trial Site
state: Texas
city: Plano
country: United States
facility: Clinical Trial Site
state: Texas
city: Round Rock
country: United States
facility: Clinical Trial Site
state: Texas
city: Madison
country: United States
facility: Clinical Trial Site
state: Wisconsin
Study officials:
References: