Actively Recruiting
A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
Led by Guangzhou JOYO Pharma Co., Ltd · Updated on 2024-11-20
35
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Neuromyelitis spectrum disease (NMOSD) patients according to 2015 International consensus diagnostic criteria.
- Positive Aquaporin 4 immunoglobulin G (AQP4-IgG).
- Patients with acute NMOSD.
- Female serum pregnancy test results were negative at the time of screening, subject (including partner) had no child-rearing plan and voluntarily adopted double contraceptive (non-oral contraceptives) within 6 months from screening to the last study drug administration, and had no sperm/egg donation plan.
- Have fully understood this study, voluntarily participate in the experiment, and voluntarily sign the written informed consent.
You will not qualify if you...
- Pregnant or lactating women.
- Suspected or clear allergy to similar ingredients or any ingredient in the study drug, or allergic constitution.
- Symptoms improved in the acute phase before the study drug was used.
- Unable to complete MRI or gadolinium enhanced examination.
AI-Screening
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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.
CONTACT
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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