Uveitis
Conditions
Brief summary
This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.
Interventions
DRUGGenSci048
Administered SC.
DRUGPlacebo
Administered SC.
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, regardless of gender; 2. Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis, and had a medical history of more than 1 yearsince the initial diagnosis; 3. Must have active disease at the baseline visit while receiving a stable dose of oral prednisone maintenance therapy for at least 2 weeks; 4. Must have demonstrated a prior adequate response to oral corticosteroid therapy (equivalent of oral prednisone up to 1 mg/kg/day), as judged by the investigator; 5. No intention to become pregnant and willingness to use highly effective contraception during the study and for 24 weeks after the last dose of study drug; 6. Able to understand the study procedures, voluntarily agree to participate, provide written informed consent (ICF), and comply with study requirements and complete the study.
Exclusion criteria
1. Subjects with isolated anterior uveitis; 2. Subjects with neovascular/wet age-related macular degeneration, proliferative or severe non-proliferative diabetic retinopathy, or clinically significant macular edema due to diabetic retinopathy; 3. Subjects with systemic inflammatory diseases requiring continued treatment with oral corticosteroids or prohibited immunosuppressive agents at screening or baseline visits; 4. Any of the following: Confirmed active tuberculosis (TB) infection, including but not limited to radiologically confirmed active TB; Subjects with latent TB infection or at high risk for TB may be enrolled, provided they are not considered unsuitable by the investigator (e.g., unwillingness to continue anti-TB treatment per local guidelines after entering the study); 5. Presence of significant comorbidities, including but not limited to: uncontrolled hypertension (≥200/105 mmHg), congestive heart failure (Stage D), or uncontrolled type 1 or type 2 diabetes (fasting blood glucose \>7.0 mmol/L or random blood glucose \>11.1 mmol/L); eligibility will be determined at the discretion of the investigator; 6. Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any other biologic therapy with a potential therapeutic impact on non-infectious uveitis (intravitreal anti-VEGF therapy excluded) within 12 weeks prior to baseline visit;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of GenSci048 administered by subcutaneous injection | 25 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of GenSci048 administered by subcutaneous injection | From Baseline until end of study/early termination visit (up to 29 weeks) | 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). |
| The Pharmacokinetic (PK) characteristics and immunogenicity of GenSci048 administered by subcutaneous injection | 197 days | PK; Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) (if applicable). |
| Incidence and severity of treatment-emergent adverse events (TEAEs) | 197 days | — |
Countries
China
Contacts
CONTACTJingsi Li
Outcome results
None listed