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

August 15, 2024 updated by: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

A Phase Ib/III Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMC-002
intravenous injection of 0.8mg/kg、1.2mg/kg
Drug: IMC-002
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.
Active Comparator: mycophenolate mofetil， MMF
mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral.
Drug: mycophenolate mofetil， MMF
daily oral 0.2g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of relapse-free patients
Time Frame: Up to Week 24
Up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first relapse (TFR)
Time Frame: Up to Week 24
Up to Week 24
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
Time Frame: Baseline (Day -28 to Day -1) to Week 24
The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability
Baseline (Day -28 to Day -1) to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 10, 2024

Primary Completion (Estimated)

November 10, 2025

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMC002-N-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuromyelitis Optica Spectrum Disorder (NMOSD)

Clinical Trials on IMC-002

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe