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

Официальное название

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

Обзор

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

Вмешательства

• Препарат GenSci048
  Administered SC.
• Препарат Placebo
  Administered SC.

Первичные конечные точки

• The effectiveness of GenSci048 administered by subcutaneous injection [Срок оценки: 25 weeks]

Вторичные конечные точки (3)

• The effectiveness of GenSci048 administered by subcutaneous injection [Срок оценки: 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 [Срок оценки: 197 days]
• Incidence and severity of treatment-emergent adverse events (TEAEs) [Срок оценки: 197 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eye & Ent Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07547995 · GenSci048-206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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