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Recruiting NCT07547995

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

Phase II Interventional Uveitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GenSci048, Placebo.
Who it may be relevant to
Registry conditions: Uveitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Clinical Study to Assess the Efficacy and Safety of GenSci048 in Subjects With Active Non-infectious Uveitis.

Overview

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

Interventions

  • Drug GenSci048
    Administered SC.
  • Drug Placebo
    Administered SC.

Primary outcome measures

  • The effectiveness of GenSci048 administered by subcutaneous injection [Time frame: 25 weeks]
Secondary outcome measures (3)
  • The effectiveness of GenSci048 administered by subcutaneous injection [Time frame: From Baseline until end of study/early termination visit (up to 29 weeks)]
  • The Pharmacokinetic (PK) characteristics and immunogenicity of GenSci048 administered by subcutaneous injection [Time frame: 197 days]
  • Incidence and severity of treatment-emergent adverse events (TEAEs) [Time frame: 197 days]

Eligibility criteria

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 while receiving a stable dose of oral prednisone maintenance therapy for at least 2 weeks;
  • 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 baseline visits;
  • 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);

  • 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 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Eye & Ent Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07547995 · GenSci048-206

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗