Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

NCT06068829 | Unknown

• 1 other identifier: IRNMO-001
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neuromyelitis Optica Spectrum Disorders

Keywords

Neuromyelitis Optica Spectrum Disorders; Inebilizumab; Rituximab

Outcome Measures

Primary Outcomes (3)

• Change in Expanded Disability Status Scale Score (EDSS) from baseline.

  Change in Expanded Disability Status Scale (EDSS) score from baseline to 12 months after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

  12 months

• Time to first relapse

  Relapse: A monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system (CNS), developing acutely or subacutely, with a duration of at least 24h, without fever or infection.

  12 months

• Number of new, and/or enlarging T2- hyperintense lesions detected by Magnetic Resonance Imaging (MRI)

  Number of new, and/or enlarging T2-hyperintense lesions detected by Magnetic Resonance Imaging (MRI) at the last visit.

  12 months

Secondary Outcomes (14)

• Change in Expanded Disability Status Scale (EDSS) score from baseline

  6 months

• Percentage of Participants with Disability Improvement

  12 months

• Percentage of Participants with Disability Worsening

  12 months

• Change in modified Rankin score (mRS) from baseline

  12 months

• Change in Timed 25 Foot Walk Test from baseline

  12 months

Study Arms (2)

Exposed group 1

Intravenous methylprednisolone (IVMP) plus Inebilizumab

Drug: Inebilizumab

Exposed group 2

IVMP plus Rituximab (RTX)

Drug: Rituximab(RTX)

Interventions

Inebilizumab DRUG

Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP.

Exposed group 1

Rituximab(RTX) DRUG

RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP.

Exposed group 2

Eligibility Criteria

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

Study Population

Patients with Neuromyelitis Optica Spectrum Disorders

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Feng Jinzhou: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected before the treatment and at the last follow-up.

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

inebilizumab; Rituximab

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)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jinzhou Feng, Ph.D

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinzhou Feng, Ph.D

CONTACT

023-89012487; 203756@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: October 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-09