🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
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
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2026-06-29
Last updated
2026-07-24

Condition(s) studied

Uveitis

Investigational drug(s) / intervention(s)

GenSci048Placebo

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

Sex
ALL
Min age
18 Years
Max age
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Eye & Ent Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

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