Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05891379
• Other study ID #: XMEC-2023-003
• Status: Not yet recruiting
• Start date: July 20, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Junwei Hao, MD
• Phone: 01083198277
• Email: haojunwei[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

Intervention

Drug:
• Inebilizumab
Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP.
• oral immunosuppressant
Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Expanded Disability Status Scale (EDSS) score from baseline	Change in Expanded Disability Status Scale (EDSS) score from baseline at month 1, month 3(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).	1 months, 3 months
Secondary	Percentage of Participants With Disability Improvement	Disability improvement is defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5(EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).	6 months
Secondary	Change in modified Rankin score (mRS) from baseline	Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).	1 months, 3 months, 6 months
Secondary	Time to first relapse		6 months
Secondary	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	6 months
Secondary	Change in Timed 25 Foot Walk Test from baseline	Change in time taken to complete the timed 25 foot walk test from baseline	1 months, 3 months , 6 months
Secondary	Number of NMOSD attacked related rescue treatment		6 months
Secondary	Change in serum GFAP levels from baseline	Change in serum GFAP levels from baseline at the last visit	6 months
Secondary	Change in AQP4-ab titers from baseline	Change in AQP4-ab titers from baseline at the last visit	6 months
Secondary	Change in Low-contrast Visual Acuity (LCVA) from baseline	Change in Low-contrast Visual Acuity (LCVA) at month 3, month 6)(The LCVA test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters).	3 months, 6 months
Secondary	Changes in EQ-5D-5L scores from baseline	Changes in EQ-5D scores from baseline at month 1 month, month 3 , month 6(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life).	1 month, 3 months ,6 months
Secondary	Change in retinal nerve fiber layer (RNFL) loss from baseline	Change in retinal nerve fiber layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 1, month 3,month 6.	3 months ,6 months