A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangzhou JOYO Pharma Co., Ltd
About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- JYP0061
- Intravenous Glucocorticoids
- Oral Glucocorticoids
Treatment groups
35 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov