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

Guangzhou JOYO Pharma

Status and phase: Enrolling; Phase 2

Conditions: Neuromyelitis Optica Spectrum Disorders

Treatments: Drug: Intravenous Glucocorticoids; Drug: JYP0061; Drug: Oral Glucocorticoids

Study type: Interventional

Funder types: Industry

Identifiers

NCT06697535

JYP0061M202

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)

Experimental group

Description:

Participants in this group will receive JYP0061, starting with a higher dose for the initial weeks, followed by a reduced maintenance dose. In addition, participants will receive a regimen of glucocorticoids, starting with intravenous administration and transitioning to oral dosing with a gradually tapering dose over time.

Treatment:

Drug: Oral Glucocorticoids

Drug: JYP0061

Drug: Intravenous Glucocorticoids

Standard Dose Glucocorticoids (Groups B1 and B2)

Active Comparator group

Description:

Participants in this group will receive a standard glucocorticoid regimen, starting with intravenous glucocorticoids at higher doses, with doses tapering over time, and then transitioning to an oral glucocorticoid regimen that also tapers gradually. During the second phase, adjustments may be made based on the participant's clinical response.

Treatment:

Drug: Oral Glucocorticoids

Drug: Intravenous Glucocorticoids

High-dose JYP0061 (Group C)

Experimental group

Description:

Participants in this group will receive a higher dose of JYP0061 for the initial weeks, followed by a lower maintenance dose for the remainder of the study period.

Treatment:

Drug: JYP0061