A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Interventions
- Registration Number
- NCT06697535
- Lead Sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Brief 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.
- Detailed Description
This study will be an open-label, multicenter phase 2 clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be treated with low-dose JYP0061 in combination with reduced dose glucocorticoids or standard dose glucocorticoids. The efficacy and safety measures will be conducted according to the protocol. If JYP0061 is effective and safe for acute NMOSD patients, then subjects will be treated with high-dose JYP0061 or standard dose glucocorticoid. The efficacy and safety measures will be conducted according to the protocol.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A) JYP0061 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. Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A) Intravenous Glucocorticoids 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. Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A) Oral Glucocorticoids 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. Standard Dose Glucocorticoids (Groups B1 and B2) Intravenous Glucocorticoids 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. Standard Dose Glucocorticoids (Groups B1 and B2) Oral Glucocorticoids 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. High-dose JYP0061 (Group C) JYP0061 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.
- Primary Outcome Measures
Name Time Method Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment 6 weeks after the first administration of the medication. This outcome assesses the clinical efficacy of JYP0061 in acute-phase NMOSD patients. The proportion of participants achieving various levels of recovery-Complete Recovery (CR), Good Recovery (GR), Moderate Recovery (MR), and Poor Recovery (PR)-will be evaluated based on the Expanded Disability Status Scale (EDSS) after 6 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants Weeks 2, 4, 6, 14, and 26. This outcome measures the maximum plasma concentration (Cmax) of JYP0061 in participants with NMOSD, assessed at Weeks 2, 4, 6, 14, and 26 following administration.
Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants Weeks 2, 4, 6, 14, and 26. This outcome measures the apparent clearance (CL/F) of JYP0061 in participants with NMOSD, assessed at Weeks 2, 4, 6, 14, and 26 following administration.
Trial Locations
- Locations (1)
Xiangya Hospital，Central South University
🇨🇳Changsha, Hunan, China