A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis. (NCT07547995) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial for GenSci048, what does that mean for how much is already known about its safety and whether it actually works for uveitis — and how does that compare to treatments I could access right now?
2The trial isn't recruiting yet, so how realistic is it to plan around this study, and what should I be doing in the meantime to manage my uveitis while we wait?
3GenSci048 is given by subcutaneous injection — can you tell me how often those injections would likely be needed, and is that something I could do at home or would I need to come into a clinic each time?
4Are there standard or already-approved treatments for my type of active uveitis that I should try first before considering an experimental Phase 2 drug like GenSci048?
5Given that this trial is still in Phase 2 and hasn't started enrolling yet, do you think my specific type of uveitis and its severity would even make me a realistic candidate to discuss when it does open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The effectiveness of GenSci048 administered by subcutaneous injection
. 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);