A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU (NCT07552012) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
China40 participantsStarted 2026-01-29
Plain-language 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
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Subject must have active disease at the screening and baseline visit, as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent):
Exclusion criteria
✕. 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);
What they're measuring
1
The percentage of patients meeting treatment failure criteria from week 6 to week 24.
Timeframe: 24 weeks
Trial details
NCT IDNCT07552012
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
. Participants with ocular masquerade syndrome, including but not limited to the following causes: trauma, lymphoma, ocular malignant tumor, or surgery;
✕. Participants with serpiginous choroidopathy;
✕. Participants with corneal or lens opacity that precludes visualization of the fundus in either eye or that likely requires cataract surgery during the duration of the trial;
✕. Participants with severe vitreous opacity or other factors that precludes visualization of the fundus in either eye;