Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

Launched by XUANWU HOSPITAL, BEIJING · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called inebilizumab for treating patients with acute Neuromyelitis Optica Spectrum Disorder (NMOSD). NMOSD is a condition that affects the nervous system and can cause severe symptoms. The goal of the study is to see how effective inebilizumab is in helping patients during the acute phase of this disorder, which is when they experience new or worsening symptoms.

To participate, you need to be at least 18 years old and have a specific type of NMOSD confirmed by a blood test. You should also be experiencing new symptoms or a worsening of existing symptoms within the last month and planning to receive certain treatments, like intravenous steroids. If you decide to join the study, you will receive the medication and be monitored for its effects on your health. It’s important to note that certain conditions, such as being pregnant or having certain infections, may prevent you from participating. If you have any questions or think you might be eligible, please reach out to the study team for more information.

Gender

ALL

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.