Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

NCT ID: NCT05891379

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2025-07-31

Brief Summary

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

Detailed Description

This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.

Conditions

Neuromyelitis Optica Spectrum Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed group

intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab

Inebilizumab

Intervention Type: DRUG

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

Non-exposed group

IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine)

oral immunosuppressant

Intervention Type: DRUG

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

Interventions

Inebilizumab

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

Intervention Type: DRUG

oral immunosuppressant

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

Intervention Type: DRUG

Eligibility Criteria

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. 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.

Exclusion Criteria

• 1. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junwei Hao, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Junwei Hao, MD

Role: CONTACT

haojunwei@vip.163.com

010-83198277

Facility Contacts

Junwei Hao

Role: primary

haojunwei@vip.163.com

010-83198277

Other Identifiers

XMEC-2023-003

Identifier Type: -

Identifier Source: org_study_id