Evaluating JYP0061 for treating acute Neuromyelitis Optica Spectrum Disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of JYP0061 in patients diagnosed with acute Neuromyelitis Optica Spectrum Disorders (NMOSD). Participants will receive either low-dose JYP0061 in combination with reduced or standard doses of glucocorticoids, or high-dose JYP0061, depending on the initial treatment's effectiveness. The study will be conducted as an open-label, multicenter phase 2 trial, with a 2-week screening period to determine eligibility. Efficacy and safety evaluations will be systematically conducted throughout the trial according to the established protocol.

Why it matters

Who can join: the full rules

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;

Where it's running

• Xiangya Hospital，Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Yang huan, M.D.
• Email: yangh69@126.com
• Phone: +86 731-84327919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.