What is GenSci048 studying for active non-infectious uveitis?

GenSci048 is being studied to evaluate its effectiveness and safety in treating active non-infectious uveitis. Researchers want to see how this drug, given by subcutaneous injection, compares to a placebo in reducing disease activity. The trial is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.

Who may be eligible for this uveitis clinical trial?

Adults aged 18 years and older with active non-infectious intermediate, posterior, or pan-uveitis for over one year may be eligible. Participants should be on a stable dose of oral prednisone and have responded to corticosteroid therapy. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this uveitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07547995

Phase II Study Evaluating Subcutaneous GenSci048 Versus Placebo in Adults With Active Non-infectious Uveitis

Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-07-24

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of GenSci048 compared with a placebo in adults with active non-infectious uveitis. This phase II study focuses on patients who have intermediate, posterior, or pan-uveitis and have had the condition for over a year. The study aims to understand how well GenSci048 works when given by subcutaneous injection and to monitor any potential side effects. Participants receive either a high dose of GenSci048 or a placebo by subcutaneous injection every four weeks according to the study protocol. The study is randomized and participants are assigned to one of the two groups. The treatment period lasts up to 25 weeks, with ongoing assessments of the drugs pharmacokinetics and immunogenicity continuing for up to 197 days. During the study, participants will have regular visits for dosing and assessments that include monitoring for treatment effectiveness and safety. Researchers will evaluate the response to treatment, track any adverse events, and collect data on the bodys handling of the drug. The total follow-up may last up to 29 weeks, allowing comprehensive observation of treatment impact and safety over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Diagnosed with non-infectious intermediate, posterior, or pan-uveitis with a history of more than 1 year
Active disease at baseline while on a stable oral prednisone dose for at least 2 weeks
Prior adequate response to oral corticosteroid therapy
No intention to become pregnant and willingness to use effective contraception during and for 24 weeks after the study
Ability to understand, consent, and comply with study procedures

You will not qualify if you...

Isolated anterior uveitis
Neovascular/wet age-related macular degeneration or severe diabetic eye disease
Systemic inflammatory diseases requiring continued corticosteroids or prohibited immunosuppressants
Confirmed active tuberculosis infection
Significant uncontrolled comorbidities such as hypertension, heart failure, or diabetes
Prior exposure to anti-TNF or other biologic therapies affecting uveitis within 12 weeks before baseline

Research Team

Jingsi Li

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