Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

NCT05891379 | Recruiting

• 1 other identifier: XMEC-2023-003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

Conditions

Neuromyelitis Optica Spectrum Disorder

Keywords

Neuromyelitis Optica Spectrum Disorder; inebilizumab; observational study

Outcome Measures

Primary Outcomes (1)

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

  Change in Expanded Disability Status Scale (EDSS) score from baseline at the last visit(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

  6 months

Secondary Outcomes (12)

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

  1 months, 3 months

• Percentage of Participants With Disability Improvement

  6 months

• Change in modified Rankin score (mRS) from baseline

  1 months, 3 months, 6 months

• Time to first relapse

  6 months

• Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)

  6 months

Study Arms (2)

Exposed group

intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab

Drug: Inebilizumab

Non-exposed group

IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine)

Drug: oral immunosuppressant

Interventions

Inebilizumab DRUG

Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP.

Exposed group

oral immunosuppressant DRUG

Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.

Non-exposed group

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

NMOSD patients with acute attacks

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); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study.

You may not qualify if:

• \. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected before the treatment and at the last visit.

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

inebilizumab; Immunosuppressive Agents

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)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Junwei Hao, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Hao, MD

CONTACT

010-83198277; haojunwei@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 6, 2023
• Study Start: July 9, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)