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This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci048 High-dose group | Experimental | GenSci048 high-dose administered subcutaneously (SC) according to the protocol. |
|
| GenSci048 Low-dose group | Experimental | GenSci048 low-dose administered subcutaneously (SC) according to the protocol. |
|
| Placebo | Experimental | Administered SC every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci048 High-dose | Drug | High-dose Administered SC. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker and ER analysis | 197 days |
Inclusion Criteria:
Exclusion Criteria:
Subjects with isolated anterior uveitis;
Subjects with neovascular/wet age-related macular degeneration, proliferative or severe non-proliferative diabetic retinopathy, or clinically significant macular edema due to diabetic retinopathy;
Subjects with systemic inflammatory diseases requiring continued treatment with oral corticosteroids or prohibited immunosuppressive agents at screening or baselinevisits;
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);
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;
Subject has previous exposure toanti-tumor necrosis factor (TNF) therapy or any other biologic therapy with a potential therapeutic impact on non-infectious uveitis (intravitreal anti-VEGF therapy excluded);
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingsi Li | Contact | +86 18301941524 | lijingsi@genscigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & Ent Hospital of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| GenSci048 Low-dose |
| Drug |
Low-dose Administered SC. |
|
| Placebo | Drug | Administered SC. |
|
PK; Incidence of anti-drug antibody (ADA) and neutralizing antibody (NAb) (if applicable). |
| 197 days |
| Incidence and severity of treatment-emergent adverse events (TEAEs) | 197 days |