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N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Primary Purpose

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Inebilizumab
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders focused on measuring NMO, NMOSD, Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorders, autoimmune, demyelination, MEDI-551, monoclonal antibody, Devic's syndrome, B-cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women 18 years or older with diagnosis of NMO/NMOSD
  2. Confirmation of NMO/NMOSD status:

    1. AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
    2. AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
  3. Able and willing to give written informed consent and comply with the requirements of the study protocol.
  4. EDSS <= 7.5 (8 in special circumstances)
  5. Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.

Exclusion Criteria:

  1. Lactating and pregnant females
  2. Treatment with any investigational agent within 4 weeks of screening
  3. Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
  4. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
  5. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
  6. Receipt of the following at any time prior to randomization:

    1. Alemtuzumab
    2. Total lymphoid irradiation
    3. Bone marrow transplant
    4. T-cell vaccination therapy
  7. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
  8. Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization.
  9. Receipt of any of the following within 3 months prior to randomization:

    1. Natalizumab (Tysabri®).
    2. Cyclosporin
    3. Methotrexate
    4. Mitoxantrone
    5. Cyclophosphamide
    6. Tocilizumab
    7. Eculizumab
  10. History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
  11. Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection
  12. History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization
  13. Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo/Inebilizumab

Inebilizumab/Inebilizumab

Arm Description

Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.

AQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.

Outcomes

Primary Outcome Measures

Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.

Secondary Outcome Measures

Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP
Low-contrast visual acuity 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. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision.
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP
The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.
Number of NMOSD-related In-patient Hospitalizations During RCP
Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.
Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab
Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP.
Number of Participants With TEAEs and TESAEs During OLP
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP.
Number of Participants With TEAEs and TESAEs During SFP (Open-label Population)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. Participant who prematurely discontinued from the RCP or OLP entered in the SFP.
Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. The SFP started when a participant prematurely discontinues from the RCP or OLP.
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP
Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported.
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP
Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported.
Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)
Time to maximum serum concentration of inebilizumab during RCP is reported.
Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)
Maximum observed serum concentration of inebilizumab during RCP is reported.
Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)
Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported.
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)
Number of participants with positive ADA titer to inebilizumab during RCP is reported.
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP)
Number of participants with positive ADA titer to inebilizumab in OLP is reported.

Full Information

First Posted
July 16, 2014
Last Updated
November 3, 2021
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02200770
Brief Title
N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Official Title
A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.
Detailed Description
Inebilizumab is a genetically engineered humanized monoclonal antibody that binds to the B cell specific surface antigen cluster of differentiation (CD19) resulting in the depletion of B cells. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells, which are generally CD19 positive and CD20 negative. The main objective of this study is to determine whether inebilizumab compare to placebo decreases the risk of an attack in participants with NMO/NMOSD. This is a multicenter, multinational, randomized, double-masked, placebo controlled study with an open-label extension period to evaluate the efficacy and safety of intravenous (IV) inebilizumab in adult participants with NMO/NMOSD. After a screening period, eligible participants will enter a randomized-controlled period (RCP) of maximum 197 days where they will be randomized in a 3:1 ratio to receive either IV inebilizumab or placebo. NMO/NMOSD attacks will be evaluated by the investigator and confirmed against the attack criteria by an independent Adjudication Committee (AC). Participants for whom the attack was confirmed by the AC will be given the option to enroll into an open label period (OLP) with inebilizumab treatment. Participants who complete the RCP without experiencing an attack will be given the option to enroll into an OLP with inebilizumab treatment. The OLP will continue for a minimum of 1 year and a maximum of 3 years after the last participant enter the OLP. All participants who discontinue from the RCP or the OLP will continue in a Safety Follow-up for a total of 12 months from last dose to evaluate the long-term safety of the investigational product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
Keywords
NMO, NMOSD, Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorders, autoimmune, demyelination, MEDI-551, monoclonal antibody, Devic's syndrome, B-cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Inebilizumab
Arm Type
Placebo Comparator
Arm Description
Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants will receive IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on both Day 1 and Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.
Arm Title
Inebilizumab/Inebilizumab
Arm Type
Experimental
Arm Description
AQP4-IgG sero positive and sero negative participants will IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who enter OLP will receive IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15, followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Participants will have choice to enter in the SFP at any point during RCP or OLP and will be free to pursue other treatment options otherwise prohibited during the RCP and OLP. Participants will continue in the SFP for 12 months from last dose of study drug.
Intervention Type
Drug
Intervention Name(s)
Inebilizumab
Other Intervention Name(s)
MEDI-551
Intervention Description
Participants will receive IV inebilizumab 300 mg.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive IV placebo matched to inebilizumab.
Primary Outcome Measure Information:
Title
Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
Description
The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.
Time Frame
Day 1 (Baseline) through Day 197
Secondary Outcome Measure Information:
Title
Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP
Description
EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Time Frame
Day 1 (Baseline) through Day 197
Title
Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP
Description
Low-contrast visual acuity 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. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision.
Time Frame
Day 1 (Baseline) through Day 197
Title
Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP
Description
The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.
Time Frame
From Screening (Day -28) to Day 197
Title
Number of NMOSD-related In-patient Hospitalizations During RCP
Description
Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.
Time Frame
Day 1 (Baseline) through Day 197
Title
Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab
Description
Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported.
Time Frame
For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years)
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP.
Time Frame
Day 1 (Baseline) through Day 197
Title
Number of Participants With TEAEs and TESAEs During OLP
Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP.
Time Frame
Day 198 through end of OLP period (maximum of 3 years after the last participant entered, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Title
Number of Participants With TEAEs and TESAEs During SFP (Open-label Population)
Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. Participant who prematurely discontinued from the RCP or OLP entered in the SFP.
Time Frame
Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)
Title
Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population)
Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP. The SFP started when a participant prematurely discontinues from the RCP or OLP.
Time Frame
Every 3 months for a total of 1 year after the last dose of study drug (approximately 3 years)
Title
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP
Description
Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported.
Time Frame
Day 1 (Baseline) through Day 197
Title
Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP
Description
Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported.
Time Frame
Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Title
Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)
Description
Time to maximum serum concentration of inebilizumab during RCP is reported.
Time Frame
Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Title
Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)
Description
Maximum observed serum concentration of inebilizumab during RCP is reported.
Time Frame
Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Title
Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)
Description
Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported.
Time Frame
Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Title
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)
Description
Number of participants with positive ADA titer to inebilizumab during RCP is reported.
Time Frame
Pre and post dose on Day 1; and on Days 29, 85, and 197
Title
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP)
Description
Number of participants with positive ADA titer to inebilizumab in OLP is reported.
Time Frame
Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 years or older with diagnosis of NMO/NMOSD Confirmation of NMO/NMOSD status: AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years Able and willing to give written informed consent and comply with the requirements of the study protocol. EDSS <= 7.5 (8 in special circumstances) Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product. Exclusion Criteria: Lactating and pregnant females Treatment with any investigational agent within 4 weeks of screening Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization Receipt of the following at any time prior to randomization: Alemtuzumab Total lymphoid irradiation Bone marrow transplant T-cell vaccination therapy Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal. Receipt of intravenous immunoglobulin (IVIG) within 1 month prior to randomization. Receipt of any of the following within 3 months prior to randomization: Natalizumab (Tysabri®). Cyclosporin Methotrexate Mitoxantrone Cyclophosphamide Tocilizumab Eculizumab History of Hepatitis B and/or Hepatitis C (Hep B/C at screening) Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MedImmune, LLC MedImmune, LLC
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131-2374
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44906
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Research Site
City
Melbourne
ZIP/Postal Code
3065
Country
Australia
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
110131
Country
Colombia
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Research Site
City
Cali
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
121 11
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Research Site
City
HongKong
Country
Hong Kong
Facility Name
Research Site
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Research Site
City
Aomori-shi
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
604-8453
Country
Japan
Facility Name
Research Site
City
Ota-ku
ZIP/Postal Code
145-0065
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Tsukuba
ZIP/Postal Code
305-8577
Country
Japan
Facility Name
Research Site
City
Goyang
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Research Site
City
Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
143729
Country
Korea, Republic of
Facility Name
Research Site
City
Ciudad De Mexico
ZIP/Postal Code
14269
Country
Mexico
Facility Name
Research Site
City
Mexico City
ZIP/Postal Code
03310
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
ZIP/Postal Code
78090
Country
Mexico
Facility Name
Research Site
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Facility Name
Research Site
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Bellavista
ZIP/Postal Code
CALLAO 2
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 01
Country
Peru
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Research Site
City
Lódz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-560
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Research Site
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Research Site
City
Khabarovsk
ZIP/Postal Code
680009
Country
Russian Federation
Facility Name
Research Site
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
63007
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644033
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11129
Country
Serbia
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Changhua City
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Research Site
City
Hualien City
ZIP/Postal Code
97002
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35170
Country
Turkey
Facility Name
Research Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
36370634
Citation
Bennett JL, Aktas O, Rees WA, Smith MA, Gunsior M, Yan L, She D, Cimbora D, Pittock SJ, Weinshenker BG, Paul F, Marignier R, Wingerchuk D, Cutter G, Green A, Hartung HP, Kim HJ, Fujihara K, Levy M, Katz E, Cree BAC; N-MOmentum study investigators. Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial. EBioMedicine. 2022 Dec;86:104321. doi: 10.1016/j.ebiom.2022.104321. Epub 2022 Nov 10.
Results Reference
derived
PubMed Identifier
35158461
Citation
Flanagan EP, Levy M, Katz E, Cimbora D, Drappa J, Mealy MA, She D, Cree BAC. Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study. Mult Scler Relat Disord. 2022 Jan;57:103352. doi: 10.1016/j.msard.2021.103352. Epub 2021 Oct 26.
Results Reference
derived
PubMed Identifier
33771837
Citation
Marignier R, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Green AJ, Aktas O, Hartung HP, Lublin FD, Williams IM, Drappa J, She D, Cimbora D, Rees W, Smith M, Ratchford JN, Katz E, Cree BAC; N-MOmentum Study Investigators. Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 26;8(3):e978. doi: 10.1212/NXI.0000000000000978. Print 2021 May.
Results Reference
derived
PubMed Identifier
33724534
Citation
Aktas O, Smith MA, Rees WA, Bennett JL, She D, Katz E, Cree BAC; N-MOmentum scientific group and the N-MOmentum study investigators. Serum Glial Fibrillary Acidic Protein: A Neuromyelitis Optica Spectrum Disorder Biomarker. Ann Neurol. 2021 May;89(5):895-910. doi: 10.1002/ana.26067. Epub 2021 Mar 30.
Results Reference
derived
PubMed Identifier
33538237
Citation
Cree BA, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk D, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Williams IM, Drappa J, She D, Cimbora D, Rees W, Ratchford JN, Katz E. Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD. Mult Scler. 2021 Nov;27(13):2052-2061. doi: 10.1177/1352458521988926. Epub 2021 Feb 4.
Results Reference
derived
PubMed Identifier
31495497
Citation
Cree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Lublin FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E; N-MOmentum study investigators. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019 Oct 12;394(10206):1352-1363. doi: 10.1016/S0140-6736(19)31817-3. Epub 2019 Sep 5.
Results Reference
derived
PubMed Identifier
26666258
Citation
Cree BA, Bennett JL, Sheehan M, Cohen J, Hartung HP, Aktas O, Kim HJ, Paul F, Pittock S, Weinshenker B, Wingerchuk D, Fujihara K, Cutter G, Patra K, Flor A, Barron G, Madani S, Ratchford JN, Katz E. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934. Epub 2015 Dec 14.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=CD-IA-MEDI-551-1155&amp;attachmentIdentifier=ae7e7dac-afeb-4a4e-bf68-5ce2e36292b8&amp;fileName=statistical_analysis_plan_cd-ia-medi-551-1155_amendment_4-redacted_PDFA.pdf&amp;versionIdentifier=
Description
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N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

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