Health TrialsbyHealthPanel

Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

ConditionNeuromyelitis Optica Spectrum Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

NMOSD patients with acute attacks

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Inebilizumab

    Drug

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

  • oral immunosuppressant

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Exposed group1 intervention
Group B: Non-exposed group1 intervention

Trial outcomes

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).

Time frame
6 months

Secondary outcomes

1

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).

Time frame
1 months, 3 months
2

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).

Time frame
6 months
3

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).

Time frame
1 months, 3 months, 6 months
4

Time to first relapse

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
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