A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JYP0061, Intravenous Glucocorticoids, Oral Glucocorticoids.
- Who it may be relevant to
- Registry conditions: Neuromyelitis Optica Spectrum Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug JYP0061
Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals. - Drug Intravenous Glucocorticoids
Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm. - Drug Oral Glucocorticoids
Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
Primary outcome measures
- Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment [Time frame: 6 weeks after the first administration of the medication.]
Secondary outcome measures (2)
- Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants [Time frame: Weeks 2, 4, 6, 14, and 26.]
- Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants [Time frame: Weeks 2, 4, 6, 14, and 26.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiangya Hospital，Central South University — Changsha
Identifiers
NCT: NCT06697535 · JYP0061M202