Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

Feng Jinzhou

Status: Not yet enrolling

Conditions: Neuromyelitis Optica Spectrum Disorders

Treatments: Drug: Inebilizumab; Drug: Rituximab(RTX)

Study type: Observational

Funder types: Other

Identifiers

NCT06068829

IRNMO-001

Details and patient eligibility

About

To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.

Full description

Inebilizumab is a humanized anti-CD19 monoclonal antibody. CD19 is broadly expressed on B-lineage cells, particularly late-stage memory B-lymphocytes and plasma blasts. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells.

Rituximab (RTX) is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity (ADCC)/complement-dependent cytotoxicity (CDC), promotes an immunoregulatory T-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis.

This is a retrospective, multicentre, real-world study which aims to compare Inebilizumab with RTX in neuromyelitis optica spectrum disorders patients. Eighty patients from 8 centres in China will be enrolled.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
• 2. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
• 3. Patients have given their written informed consent.

Exclusion criteria

• 1. Lactating and pregnant females.
• 2. Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
• 3. Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
• 4. Known history of a severe allergy or reaction to any component of the investigational product formulation.
• 5. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization (including viral hepatitis, active tuberculosis or positive tuberculosis screening).
• 6. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to treatment.
• 7. History of malignancies.
• 8. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up.

Trial design

80 participants in 2 patient groups

Exposed group 1

Description:

Intravenous methylprednisolone (IVMP) plus Inebilizumab

Treatment:

Drug: Inebilizumab

Exposed group 2

Description:

IVMP plus Rituximab (RTX)

Treatment:

Drug: Rituximab(RTX)