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

NCT06697535 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

  • Neuromyelitis Optica Spectrum Disorders

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.

Sponsors & Collaborators

  • Guangzhou JOYO Pharma Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2026-02-28
Completion
2026-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06697535 on ClinicalTrials.gov