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A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
Sponsor: Guangzhou JOYO Pharma Co., Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2023-05-24
Completion Date
2026-07-30
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Xiangya Hospital,Central South University
Changsha, Hunan, China