Clinical Trials in China / NCT07547995
Recruiting
Phase 2
A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.
NCT07547995 · tracked via the Priya Life Science China tracker
Condition(s) studied
Uveitis
Investigational drug(s) / intervention(s)
GenSci048 →Placebo
GenSci048: Administered SC.
Placebo: Administered SC.
Study summary
This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.
Eligibility
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;
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Eye & Ent Hospital of Fudan University | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07547995 on ClinicalTrials.gov ↗ ← All trials in China