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

Phase 2RecruitingNCT06697535

Guangzhou JOYO Pharma Co., Ltd35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuromyelitis Optica Spectrum Disorders

JYP0061DRUG

Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.

Intravenous GlucocorticoidsDRUG

Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.

Oral GlucocorticoidsDRUG

Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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;

Outcomes

Primary Outcomes

Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment

This outcome assesses the clinical efficacy of JYP0061 in acute-phase NMOSD patients. The proportion of participants achieving various levels of recovery-Complete Recovery (CR), Good Recovery (GR), Moderate Recovery (MR), and Poor Recovery (PR)-will be evaluated based on the Expanded Disability Status Scale (EDSS) after 6 weeks of treatment.

Time frame: 6 weeks after the first administration of the medication.

Secondary Outcomes

Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants

This outcome measures the maximum plasma concentration (Cmax) of JYP0061 in participants with NMOSD, assessed at Weeks 2, 4, 6, 14, and 26 following administration.

Time frame: Weeks 2, 4, 6, 14, and 26.

Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants

This outcome measures the apparent clearance (CL/F) of JYP0061 in participants with NMOSD, assessed at Weeks 2, 4, 6, 14, and 26 following administration.