Actively Recruiting
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
Led by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Updated on 2026-04-27
40
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand trial procedures, agree to participate voluntarily, communicate well, comply with study requirements, and provide written informed consent
- Male or female aged 18 to 70 years at screening
- Body mass index (BMI) between 18 and 30 kg/m², with body weight of at least 50 kg for males and 45 kg for females
- Diagnosed with active non-infectious uveitis affecting intermediate, posterior, or pan uveitis in at least one eye
- Active disease at screening and baseline defined by at least one of: active inflammatory chorioretinal or retinal vascular lesion, 2+ or more anterior chamber cells, or 2+ or more vitreous haze despite at least 2 weeks of oral prednisone treatment at 10 to 60 mg/day or equivalent
- Willing to use effective contraception and have no plans for reproduction, sperm donation, or egg donation during treatment and for at least one month after last dose
You will not qualify if you...
- Isolated anterior uveitis only
- Macular edema as sole clinical sign of intermediate, posterior, or pan uveitis
- Confirmed or suspected infectious uveitis, including tuberculosis, cytomegalovirus, Lyme disease, toxoplasmosis, HTLV-1, Whipple's disease, or herpes simplex virus
- Histoplasmosis Syndrome
- Ocular masquerade syndrome such as trauma, lymphoma, ocular malignant tumor, or prior surgery
- Serpiginous choroidopathy
- Corneal or lens opacity preventing fundus visualization or likely needing cataract surgery during trial
- Severe vitreous opacity or other issues preventing fundus visualization
- Uncontrolled glaucoma with intraocular pressure ≥ 25 mmHg on two or more glaucoma medications or optic nerve injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
EC of the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
Research Team
Y
Yang
CONTACT
Y
Ye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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