A Phase 2 interventional study of JYP0061 and Intravenous Glucocorticoids in Neuromyelitis Optica Spectrum Disorders, sponsored by Guangzhou JOYO Pharma Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Guangzhou JOYO Pharma Co., Ltd · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Drug: JYP0061 · Drug: Intravenous Glucocorticoids · Drug: 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.
Drug: Intravenous Glucocorticoids · Drug: Oral Glucocorticoids
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.
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.
Also known as: Experimental Drug Group
Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.
Also known as: Methylprednisolone
Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.
Also known as: Prednisone
Proportion of participants achieving clinical recovery based on EDSS after 6 weeks of treatment
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.
Time frame: 6 weeks after the first administration of the medication.
Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants
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.
Time frame: Weeks 2, 4, 6, 14, and 26.
Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants
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.
Time frame: Weeks 2, 4, 6, 14, and 26.
Plan to share: No
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Guangzhou JOYO Pharma Co., Ltd