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

What this Trial Is About

Researchers are evaluating the efficacy and safety of JYP0061 in patients with acute Neuromyelitis Optica Spectrum Disorders NMOSD. This open-label, multicenter phase 2 trial aims to determine how well JYP0061 works and how safe it is when used alone or with glucocorticoids in treating acute NMOSD. The study includes participants diagnosed by the 2015 International consensus criteria and who test positive for Aquaporin 4 immunoglobulin G AQP4-IgG. Participants will be assigned randomly to one of three groups. One group receives low-dose JYP0061 combined with reduced-dose glucocorticoids. Another group is given a standard glucocorticoid regimen that starts with intravenous administration and tapers to oral dosing. The third group receives a high dose of JYP0061 initially, followed by a lower maintenance dose. Treatment dosing and adjustments will follow the study protocol. The study starts with a 2-week screening to confirm eligibility, followed by treatment and assessments of recovery based on the Expanded Disability Status Scale EDSS after 6 weeks. Additional evaluations include measuring JYP0061 levels in plasma and how the drug is processed in the body at various weeks during treatment. Participants are monitored closely for safety and response throughout the trial, which continues until July 2026.

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