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A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)

ConditionNeuromyelitis Optica Spectrum Disorders
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangzhou JOYO Pharma Co., Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • JYP0061

    Drug

    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

    Drug

    Administered intravenously with a gradually decreasing dose over time, as specified in the Standard Dose Glucocorticoids arm.

  • Oral Glucocorticoids

    Drug

    Administered orally with a tapered dosing schedule, as specified in the Standard Dose Glucocorticoids arm, with adjustments based on participant response.

Treatment groups

35 Participants
are divided into 3 treatment groups
Group A: Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)Experimental treatment 3 interventions
Group B: Standard Dose Glucocorticoids (Groups B1 and B2)Active comparator 2 interventions
Group C: High-dose JYP0061 (Group C)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou JOYO Pharma Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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