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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Xiangya Hospital，Central South University
RECRUITING
Changsha
Contact Information
Primary
Yang huan, M.D.
yangh69@126.com
+86 731-84327919
Time Frame
Start Date:2023-05-24
Estimated Completion Date:2026-07-30
Participants
Target number of participants:35
Treatments
Experimental: Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)
Participants in this group will receive JYP0061, starting with a higher dose for the initial weeks, followed by a reduced maintenance dose. In addition, participants will receive a regimen of glucocorticoids, starting with intravenous administration and transitioning to oral dosing with a gradually tapering dose over time.
Active_comparator: Standard Dose Glucocorticoids (Groups B1 and B2)
Participants in this group will receive a standard glucocorticoid regimen, starting with intravenous glucocorticoids at higher doses, with doses tapering over time, and then transitioning to an oral glucocorticoid regimen that also tapers gradually. During the second phase, adjustments may be made based on the participant's clinical response.
Experimental: High-dose JYP0061 (Group C)
Participants in this group will receive a higher dose of JYP0061 for the initial weeks, followed by a lower maintenance dose for the remainder of the study period.