RecruitingNCT05891379

Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study

Sponsor

Xuanwu Hospital, Beijing

Enrollment

50 participants

Start Date

Jul 9, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

\. 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.

\. 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.

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DRUGInebilizumab

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

DRUGoral immunosuppressant

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

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT05891379