A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
What it found
No result yet.
What was tested
Treatment tested
- JYP0061
- Methylprednisolone
Glucocorticoid receptor agonist
- Prednisone
Glucocorticoid receptor agonist
What it measured
Main measures
Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment
6 weeks after the first administration of the medication.
Disability progression
Other measures (2)
Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants
Weeks 2, 4, 6, 14, and 26.
How the body handles the medicineApparent Clearance (CL/F) of JYP0061 in NMOSD Participants
Weeks 2, 4, 6, 14, and 26.
How the body handles the medicine
Who could take part
NMOSD · 18 to 65
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;
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
May 2023
Main results due
Feb 2026
Finished
Jul 2026
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