New drug aims to tame eye inflammation in uveitis patients
NCT ID NCT07547995
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests a new drug, GenSci048, in people with active non-infectious uveitis, an inflammatory eye disease. The trial will compare two doses of GenSci048 against a placebo to see if it can control the disease and reduce treatment failure. About 111 adults with active uveitis will participate, and the main goal is to measure how many avoid worsening of their condition over 25 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GenSci048
- What this could lead to
- If successful, this could provide a new treatment option to control active non-infectious uveitis, potentially reducing the need for high-dose steroids.
- What could go wrong
- This is an early Phase 2 trial with only 111 participants, so results may not apply to all patients. The drug may not prove more effective than placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Eye & Ent Hospital of Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200031, China
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