A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With
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).
| Condition(s) | Active Non-anterior, Non-infectious Uveitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | Inclusion Criteria: 1. 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); 2. At screening visit, male or female paticipants aged 18-70 years (inclusive) ; 3. 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; 4. 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; 5. Subject must have active disease at the screening and baseline visit, as defined by the presence of at leas |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. |
| Locations | Chongqing, Chongqing Municipality, China |
| Start date | 2026-01-29 |
| NCT ID | NCT07552012 |
| Official listing | https://clinicaltrials.gov/study/NCT07552012 |