A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
NCT ID: NCT06697535
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
35 participants
INTERVENTIONAL
2023-05-24
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
JYP0061
Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.
Intravenous Glucocorticoids
Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
Oral Glucocorticoids
Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
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.
Intravenous Glucocorticoids
Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
Oral Glucocorticoids
Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
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.
JYP0061
Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.
Interventions
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JYP0061
Administered orally with a dose reduction over time as specified in Arm descriptions. Tablets are taken within a specific time frame after meals.
Intravenous Glucocorticoids
Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
Oral Glucocorticoids
Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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;
18 Years
65 Years
ALL
No
Sponsors
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Guangzhou JOYO Pharma Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Xiangya Hospital，Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JYP0061M202
Identifier Type: -
Identifier Source: org_study_id
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