The purpose of this study is to find out the efficacy and safety of oral FXS5626 in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
This study is a multicenter, randomized, double-blind, placebo-controlled study conducted in china, aimed at evaluating the efficacy, safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of FXS5626 administered twice daily for 24 weeks in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis(NIU). This study plans to enroll 40 patients with active non-anterior NIU. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly allocated into 3 groups in a 2:1:1 ratio. Participants in groups 1 and 2 will receive different doses of FXS5626. Participants in group 3 will receive placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Administered twice per day for 24 weeks.
Administered twice per day for 24 weeks.
Administered twice per day for 24 weeks.
EC of the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe percentage of patients meeting treatment failure criteria from week 6 to week 24.
Time frame: 24 weeks
Time to Treatment Failure from week 6 to week 24.
Time frame: 24 weeks
At each visit,change in Anterior Chamber (AC) cells grade for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
At each visit, change in Vitreous Haze (VH) grade for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
At each visit, change in BCVA for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least 1 eye from Week 6.
Time frame: 24 weeks
At each visit, change in Central Retinal Thickness (CRT) for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
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