JYP0061: Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.
Intravenous Glucocorticoids: Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
Oral Glucocorticoids: Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment — 6 weeks after the first administration of the medication. 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.
Trial sites (1)
Facility
City
Region
Status
Xiangya Hospital，Central South University
Changsha
Hunan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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