This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe effectiveness of GenSci048 administered by subcutaneous injection
Calculate the proportion of subjects with treatment failure at Week 25 for each GenSci048 dose group and the placebo group, respectively. A superiority test (α=0.05, two-tailed) for the proportion of subjects with treatment failure at Week 25 between each GenSci048 dose group and the placebo group is performed using the stratified Cochran-Mantel-Haenszel (CMH) method.
Time frame: 25 weeks
The effectiveness of GenSci048 administered by subcutaneous injection
The change of different ophthalmic parameters at weeks 5, 9, 13, 17, 21, and 25 to baseline and best state achieved prior to week 5(inclusive).
Time frame: From Baseline until end of study/early termination visit (up to 29 weeks)
The Pharmacokinetic (PK) characteristics and immunogenicity of GenSci048 administered by subcutaneous injection
PK; Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) (if applicable).
Time frame: 197 days
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 197 days
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