Tests JYP0061 in adults with acute neuromyelitis optica spectrum disorder
Tests JYP0061 with steroids in adults during acute neuromyelitis optica spectrum flares.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
Key facts
- Where
- Changsha, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06697535, who can take part
Where in China
- Xiangya Hospital Central South UniversityChangsha, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangzhou JOYO Pharma Co., Ltd
- Trial code
- NCT06697535
- Record updated
- 20 November 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Symptoms improved in the acute phase before the study drug was used; Suspected or clear allergy to similar ingredients or any ingredient in the study drug, or allergic constitution; Pregnant or lactating women; Unable to complete MRI or gadolinium enhanced examination.