Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Phase
Phase 2
Started
2026-01-29
Last updated
2026-04-27
Condition(s) studied
Active Non-anterior, Non-infectious Uveitis
Investigational drug(s) / intervention(s)
FXS5626 tabletFXS5626 tabletPlacebo
FXS5626 tablet: Administered twice per day for 24 weeks.
FXS5626 tablet: Administered twice per day for 24 weeks.
Placebo: Administered twice per day for 24 weeks.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 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):
1\) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria) 3) ≥ 2+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria) ; \[6\] Participants and their partners must have no plans for reproduction, sperm donation, or egg donation from the start of treatment until at least one month after the last dose of the investigational drug, and must voluntarily employ an effective method of contraception as determined by the investigator.
Exclusion Criteria:
1. Participants with isolated anterior uveitis;
2. Participants with macular edema as the sole clinical manifestation of intermediate uveitis, posterior uveitis, or panuveitis;
3. 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);
4. Participants with Histoplasmosis Syndrome (HS);
5. Participants with ocular masquerade syndrome, including but not limited to the following causes: trauma, lymphoma, ocular malignant tumor, or surgery;
6. Participants with serpiginous choroidopathy;
7. 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;
8. Participants with severe vitreous opacity or other factors that precludes visualization of the fundus in either eye;
9. Participant with uncontrolled glaucoma, intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury; The sponsor provides the definitive and complete eligibility criteria in the study protocol.
Primary outcome measure(s)
The percentage of patients meeting treatment failure criteria from week 6 to week 24. — 24 weeks
Trial sites (1)
Facility
City
Region
Status
EC of the First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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