About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- FXS5626 tablet
- FXS5626 tablet
- Placebo