A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD): a Multicenter, Randomized, Open-label, Positive-controlled, Two-stage Exploratory Phase 2 Trial
Guangzhou JOYO Pharma Co., Ltd
35 participants
May 24, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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;
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Interventions
Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.
Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06697535