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RECRUITING
NCT06697535
PHASE2

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

Sponsor: Guangzhou JOYO Pharma Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

JYP0061

Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.

DRUG

Intravenous Glucocorticoids

Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.

DRUG

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