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

Recruiting now · Phase 2

Conditions studied: Neuromyelitis Optica Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT06697535

Run by

Guangzhou JOYO Pharma Co., Ltd

People needed

35

Starts

2023-05-24

Expected to finish

2026-07-30

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Xiangya Hospital，Central South University — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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