Actively Recruiting
Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD) Multicenter, Randomized, Open-label, Two-stage Exploratory Phase 2 Trial
Led by Guangzhou JOYO Pharma Co., Ltd · Updated on 2024-11-20
35
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of JYP0061 in patients with acute Neuromyelitis Optica Spectrum Disorders (NMOSD). This open-label, multicenter phase 2 trial aims to determine how well JYP0061 works and how safe it is when used alone or with glucocorticoids in treating acute NMOSD. The study includes participants diagnosed by the 2015 International consensus criteria and who test positive for Aquaporin 4 immunoglobulin G (AQP4-IgG). Participants will be assigned randomly to one of three groups. One group receives low-dose JYP0061 combined with reduced-dose glucocorticoids. Another group is given a standard glucocorticoid regimen that starts with intravenous administration and tapers to oral dosing. The third group receives a high dose of JYP0061 initially, followed by a lower maintenance dose. Treatment dosing and adjustments will follow the study protocol. The study starts with a 2-week screening to confirm eligibility, followed by treatment and assessments of recovery based on the Expanded Disability Status Scale (EDSS) after 6 weeks. Additional evaluations include measuring JYP0061 levels in plasma and how the drug is processed in the body at various weeks during treatment. Participants are monitored closely for safety and response throughout the trial, which continues until July 2026.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Neuromyelitis Spectrum Disease (NMOSD) according to 2015 International consensus diagnostic criteria
- Positive for Aquaporin 4 immunoglobulin G (AQP4-IgG)
- Currently experiencing acute NMOSD
- Female participants must have a negative pregnancy test at screening, no child-rearing plans, use double non-oral contraception during the study, and have no sperm or egg donation plans
- Able to understand the study and provide written informed consent voluntarily
You will not qualify if you...
- Pregnant or breastfeeding women
- Allergy or suspected allergy to any ingredients of the study drug
- Symptoms improved during the acute phase before using the study drug
- Unable to complete MRI or gadolinium-enhanced examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 weeks
Participants receive treatment with JYP0061 in combination with glucocorticoids or glucocorticoids alone, with dosing schedules varying by group.
Visits at Weeks 2, 4, and 6 for assessments
Duration - Up to 20 weeks after initial 6-week treatment
If initial treatment is effective and safe, participants receive a higher dose of JYP0061 followed by a maintenance dose for the remainder of the study period.
Visits at Weeks 14 and 26 for assessments
Trial Site Locations
Total: 1 location
1
Xiangya Hospital，Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
Research Team
Y
Yang huan, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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