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Efficacy and Safety of JYP0061 in Acute NMOSD
NCT06697535Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2023
- Primary completion
- Feb 2026
- Countries
- 1
- Sponsor
- Guangzhou JOYO Pharma
- Modality
- Small Molecules
- Drugs
- JYP0061
- Conditions
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
01
Overview
Phase 2, randomised, open-label trial of JYP0061 in Neuromyelitis Optica Spectrum Disorder (NMOSD) (3 arms), sponsored by Guangzhou JOYO Pharma. Primary endpoint: Proportion of participants achieving clinical recovery based on EDSS at 6 weeks. Started May 2023; status: recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Low-dose JYP0061 + Reduced Steroids
JYP0061 (initial high, then maintenance) + Tapered Glucocorticoids
Standard Steroids
Standard IV to Oral Glucocorticoid taper
High-dose JYP0061
High-dose JYP0061 (initial high, then maintenance)
03
Who it enrols
Patients with acute Neuromyelitis Optica Spectrum Disorders (NMOSD) who are AQP4-IgG positive.
04
Endpoints
Primary
Proportion of participants achieving clinical recovery based on EDSS
Secondary
Maximum Plasma Concentration
Apparent Clearance
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