A Phase 2 interventional study of FXS5626 tablet and FXS5626 tablet in Active Non-anterior, Non-infectious Uveitis, sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Phase 2, Interventional, and Treatment
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).
This study is a multicenter, randomized, double-blind, placebo-controlled study conducted in china, aimed at evaluating the efficacy, safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of FXS5626 administered twice daily for 24 weeks in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis(NIU).
This study plans to enroll 40 patients with active non-anterior NIU. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly allocated into 3 groups in a 2:1:1 ratio. Participants in groups 1 and 2 will receive different doses of FXS5626. Participants in group 3 will receive placebo.
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:
Participants will receive FXS5626 50 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral
Other: FXS5626 tablet
Participants will receive FXS5626 25 mg twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral
Other: FXS5626 tablet
Participants will receive placebo twice daily (BID) , for 24 weeks. Pharmaceutical form: Tablets Route of administration: Oral
Other: Placebo
Administered twice per day for 24 weeks.
Administered twice per day for 24 weeks.
Administered twice per day for 24 weeks.
The percentage of patients meeting treatment failure criteria from week 6 to week 24.
Time frame: 24 weeks
Time to Treatment Failure from week 6 to week 24.
Time frame: 24 weeks
At each visit,change in Anterior Chamber (AC) cells grade for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
At each visit, change in Vitreous Haze (VH) grade for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
At each visit, change in BCVA for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
Time to Optical Coherence Tomography (OCT) evidence of macular edema in at least 1 eye from Week 6.
Time frame: 24 weeks
At each visit, change in Central Retinal Thickness (CRT) for each eye from the best state achieved prior to Week 6.
Time frame: 24 weeks
Plan to share: No
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Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.