Not Yet RecruitingPhase 2

A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.

China111 participantsStarted 2026-06-18

Plain-language summary

This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥18 years, regardless of gender;
✓. Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis, and had a medical history of more than 1 yearsince the initial diagnosis;
✓. Must have active disease at the baseline visit;
✓. 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;
✓. 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;
✓. Able to understand the study procedures, voluntarily agree to participate, provide written informed consent (ICF), and comply with study requirements and complete the study.

✕. 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:
✕. 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);

The effectiveness of GenSci048 administered by subcutaneous injection

Timeframe: 25 weeks

NCT IDNCT07547995

SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-14

Jingsi Li

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥18 years, regardless of gender;
✓. Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis, and had a medical history of more than 1 yearsince the initial diagnosis;
✓. Must have active disease at the baseline visit;
✓. 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;
✓. 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;
✓. Able to understand the study procedures, voluntarily agree to participate, provide written informed consent (ICF), and comply with study requirements and complete the study.

✕. 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:
✕. 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);