A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients

NCT06557174 | Not Yet Recruiting Phase 1

• 1 other identifier: IMC002-N-01
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)

Outcome Measures

Primary Outcomes (1)

• Proportion of relapse-free patients

  Up to Week 24

Secondary Outcomes (2)

• Time to first relapse (TFR)

  Up to Week 24

• Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study

  Baseline (Day -28 to Day -1) to Week 24

Study Arms (2)

IMC-002

EXPERIMENTAL

intravenous injection of 0.8mg/kg、1.2mg/kg

Drug: IMC-002

mycophenolate mofetil， MMF

ACTIVE COMPARATOR

mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral.

Drug: mycophenolate mofetil， MMF

Interventions

IMC-002 DRUG

intravenous injection: Weekly administered for a period of first 4 weeks, then rest for 20 weeks. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued.

IMC-002

mycophenolate mofetil， MMF DRUG

daily oral 0.2g

mycophenolate mofetil， MMF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years, inclusive, at the time of informed consent
• Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
• Confirmation of NMOSD diagnosis with AQP4+ antibodies
• The EDSS score should be ≤7.0
• Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening

You may not qualify if:

• Have received rituximab or other anti-CD20 drugs treatment within 6 months
• Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.
• Females who are pregnant or lactating.
• Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).

Sponsors & Collaborators

• ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.: lead

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Mycophenolic Acid

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)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Central Study Contacts

jinhua zhou

CONTACT

02138016387; jinhua.zhou@immuneonco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 16, 2024
• Study Start: October 10, 2024
• Primary Completion: November 10, 2025
• Study Completion (Estimated): July 10, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-08