A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)

Официальное название

Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD): a Multicenter, Randomized, Open-label, Positive-controlled, Two-stage Exploratory Phase 2 Trial

Обзор

The goal of this clinical trial is to evaluate the efficacy and safety, of JYP0061 in acute NMOSD patients. The main questions it aims to answer are: efficacy and safety of JYP0061 in acute NMOSD patients. Participants will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids or high-dose JYP0061. Efficacy and safety evaluations will be conducted according to the protocol.

Подробное описание

This study will be an open-label, multicenter phase 2 clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids. The efficacy and safety measures will be conducted according to the protocol. If JYP0061 is effective and safe for acute NMOSD patients, then subjects will be treated with high-dose JYP0061 or standard dose glucocorticoid. The efficacy and safety measures will be conducted according to the protocol.

Вмешательства

• Препарат JYP0061
  Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.
• Препарат Intravenous Glucocorticoids
  Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
• Препарат Oral Glucocorticoids
  Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.

Первичные конечные точки

• Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment [Срок оценки: 6 weeks after the first administration of the medication.]

Вторичные конечные точки (2)

• Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants [Срок оценки: Weeks 2, 4, 6, 14, and 26.]
• Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants [Срок оценки: Weeks 2, 4, 6, 14, and 26.]

Критерии участия

Критерии включения

• Neuromyelitis spectrum disease (NMOSD) patients according to 2015 International consensus diagnostic criteria.
• Positive Aquaporin 4 immunoglobulin G (AQP4-IgG)
• Patients with acute NMOSD
• Female serum pregnancy test results were negative at the time of screening, subject (including partner) had no child-rearing plan and voluntarily adopted double contraceptive (non-oral contraceptives) within 6 months from screening to the last study drug administration, and had no sperm/egg donation plan;
• Have fully understood this study, voluntarily participate in the experiment, and voluntarily sign the written informed consent.

Критерии исключения

• Pregnant or lactating women;
• Suspected or clear allergy to similar ingredients or any ingredient in the study drug, or allergic constitution;
• Symptoms improved in the acute phase before the study drug was used;
• Unable to complete MRI or gadolinium enhanced examination;

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xiangya Hospital，Central South University — Чанша

Идентификаторы

NCT: NCT06697535 · JYP0061M202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗