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

NCT06697535 | Recruiting Phase 2

• 1 other identifier: JYP0061M202
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromyelitis Optica Spectrum Disorders

Outcome Measures

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.

  6 weeks after the first administration of the medication.

Secondary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of JYP0061 in NMOSD Participants

  Weeks 2, 4, 6, 14, and 26.

• Apparent Clearance (CL/F) of JYP0061 in NMOSD Participants

  Weeks 2, 4, 6, 14, and 26.

Study Arms (3)

Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)

EXPERIMENTAL

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

Standard Dose Glucocorticoids (Groups B1 and B2)

ACTIVE COMPARATOR

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

High-dose JYP0061 (Group C)

EXPERIMENTAL

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

Interventions

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.

Also known as: Experimental Drug Group

High-dose JYP0061 (Group C); Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A)

Intravenous Glucocorticoids DRUG

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

Also known as: Methylprednisolone

Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A); Standard Dose Glucocorticoids (Groups B1 and B2)

Oral Glucocorticoids DRUG

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

Low-dose JYP0061 + Reduced Dose Glucocorticoids (Group A); Standard Dose Glucocorticoids (Groups B1 and B2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Xiangya Hospital，Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Methylprednisolone; Glucocorticoids; Prednisone

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols

Central Study Contacts

Yang huan, M.D.

CONTACT

+86 731-84327919; yangh69@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 20, 2024
• Study Start: May 24, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)