Clinical trial NCT05523765: A Study of Brepocitinib in Adults with Active Non-Infectious Non-Anterior Uveitis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-infectious Intermediate Uveitis
Non-infectious Posterior Uveitis
Non-infectious Pan Uveitis
Keywords: Brepocitinib
PF-06700841
uveitis
NIU
Lead sponsor: Priovant Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility 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

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Screening up to 28 days after the last dose of study drug at 52 weeks
Secondary outcomes:
measure: Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Palo Alto
country: United States
facility: Clinical Trial Site
state: California
city: Pasadena
country: United States
facility: Clinical Trial Site
state: California
city: Lakewood
country: United States
facility: Clinical Trial Site
state: Colorado
city: Waltham
country: United States
facility: Clinical Trial Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Clinical Trial Site
state: Missouri
city: Palisades Park
country: United States
facility: Clinical Trial Site
state: New Jersey
city: Durham
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Eugene
country: United States
facility: Clinical Trial Site
state: Oregon
city: Nashville
country: United States
facility: Clinical Trial Site
state: Tennessee
city: Bellaire
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: Salt Lake City
country: United States
facility: Clinical Trial Site
state: Utah
Study officials:
affiliation: SVP, Early Development
name: Brendan Johnson, PhD
role: STUDY_DIRECTOR
References: