Non-infectious Uveitis Clinical Trial
Official title:
A Phase 2, Open-Label Randomized Study to Evaluate Multiple Dosing Regimens of Subcutaneous PL8177 Administration in Subjects With Non Infectious Uveitis (NIU)
The study is a Phase 2, open-label, randomized, 4-arm, parallel group study in subjects with active non-infectious uveitis. Subjects will be randomized to receive either 0.1 mg or 1.0 mg of PL8177 SC injection as 2 single doses 48 hours apart (Group A) or as a single dose for 4 weeks (4 doses) (Group B). A total of 40 subjects are planned to be enrolled with 20 participating in each Group.
Subjects will be screened to assess their eligibility to enter the study during a 7-day
period within 39 days (Days -39 to -32) prior to the administration PL8177. On Day 1, all
subjects will be randomized to receive either 0.1 mg or 1.0 mg of PL8177 subcutaneous
injection as 2 single doses 48 hours apart (Group A) or as single weekly doses for 4 weeks
(total 4 doses) (Group B).
All doses will be administered in the morning at approximately the same time each day after
an overnight fast of at least 8 hours. A standard meal/snack will be provided at
approximately 1 hour after dose administration. Subcutaneous injections will be administered
in the anterior abdomen, in alternating quadrants. Study drug will be administered in clinic
on Days 1 and 3 (Group A) or weekly on Days 1, 8, 15, and 22 (Group B). The study treatment
period for Group A will be 3 days, followed by a 12-week post-treatment follow-up period, and
for Group B will be a total of 22 days (4 weeks), followed by an 8-week post treatment
period. A follow-up phone call will be made to each subject 4 weeks after completion of the
study.
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