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
- Principal Investigator: Laura Kopplin
- Study Coordinator: Kris Dietzman
- Study Sponsor: Priovant Therapeutics, Inc.
Study Objective
The purpose of this study is to determine the safety and efficacy (including corticosteroid[1]sparing effect) of brepocitinib (a tyrosine kinase [TYK]2/Janus kinase [JAK]1 inhibitor) in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU)
Study Design
Number of Participants Each substudy will enroll (randomize) approximately 150 participants resulting in a total of approximately 300 study participants enrolled at around 100 sites globally (including in the US, EU, UK, Asia, and Latin America).
Intervention Groups and Duration
In Period 1, participants will be randomized (1:1) to 1 of 2 treatment arms:
- Arm 1: brepocitinib 45 mg orally (PO) QD for 48 weeks;
- Arm 2: placebo PO QD for 48 weeks.
In addition to their randomized treatment with study drug, all participants will receive a standardized prednisone burst of 60 mg/day at study entry (continued for 2 weeks) followed by a protocol-defined mandatory taper schedule over the subsequent 6 weeks, such that all participants continuing in the study will discontinue prednisone by Week 8. Participants who enter the study on topical ophthalmic corticosteroids (eye drops) will undergo a standardized taper schedule (described in detail below). Participants in Period 2 will all receive brepocitinib 45 mg PO QD. Refer to Section 6.1 for information about study drug administration and Section 6.3 for further details on randomization and masking.
Randomization will be stratified based on the following baseline factor(s):
- Prior anti-TNF use (yes/no)
- Highest oral corticosteroid dose for uveitis during the 7 days prior to randomization (prednisone ≥ 10 mg/day [or equivalent] vs < 10 mg per day [which includes 0 mg or no use of oral prednisone/corticosteroid]).
Inclusion Criteria:
An individual will be eligible for participation in this study only if all of the following inclusion criteria are met:
Age and Sex
1. Male or female, and the participant must be ≥ 18 to ≤ 75 years of age at the time of signing the informed consent form (ICF).
Type of Participant and Disease Characteristics
2. Participants with a diagnosis of NIU (intermediate uveitis, posterior uveitis, or panuveitis).
3. Participant must have active uveitic disease at screening (Visit 1) and baseline (Visit 2/Day 1) as defined by the presence of at least 1 of the following parameters in at least 1 eye (same eye at screening and baseline), as determined by the investigator:
a. Active, inflammatory chorioretinal and/or retinal vascular lesion determined by clinical examination and confirmed by OCT, fundus photography, and/or fluorescein angiography;
b. ≥ 2+ vitreous haze grade (NEI/SUN criteria). Note: The central reader’s assessment of eligibility based on the submitted screening images will be provided to investigators. The investigator will document any discrepancy between the central and investigator screening assessment of eligibility. Concordance between central and investigator assessments will be monitored throughout the study.
Weight
4. Participants weighing > 40 kg and with a body mass index (BMI) ≤ 40 kg/m2 .
Contact Kris Dietzman with questions at (608) 263-9035
For more information about this study, please visit clinicaltrials.gov