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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • IMC-002
  • mycophenolate mofetil, MMF

Treatment groups

116 Participants
are divided into 2 treatment groups

Locations

This trial has no locations