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).
Participants must be capable of understanding the trial procedures, voluntarily agree to participate, communicate effectively with the investigators, comply with all study requirements throughout the trial, and provide written Informed consent Form (ICF);
At screening visit, male or female paticipants aged 18-70 years (inclusive) ;
At screening visit, Body mass index (BMI) between 18 and 30 kg/m² (inclusive), with a body weight of ≥50 kg for males and ≥45 kg for females;
At screening, at least one eye was diagnosed with active non-infectious uveitis by the investigator, including non-infectious intermediate uveitis, posterior uveitis, or panuveitis;
Participants with isolated anterior uveitis;
Participants with macular edema as the sole clinical manifestation of intermediate uveitis, posterior uveitis, or panuveitis;
Participants with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to Tuberculosis (TB), cytomegalovirus (CMV), Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease and herpes simplex virus (HSV);
Participants with Histoplasmosis Syndrome (HS);
Parallel
FXS5626 tablet
Other interventionAdministered twice per day for 24 weeks.
FXS5626 tablet
Other interventionAdministered twice per day for 24 weeks.
Placebo
Other interventionAdministered twice per day for 24 weeks.
The percentage of patients meeting treatment failure criteria from week 6 to week 24.
Time to Treatment Failure from week 6 to week 24.
At each visit,change in Anterior Chamber (AC) cells grade for each eye from the best state achieved prior to Week 6.
At each visit, change in Vitreous Haze (VH) grade for each eye from the best state achieved prior to Week 6.
At each visit, change in BCVA for each eye from the best state achieved prior to Week 6.
Click on the lead sponsor to view all of their trials.
