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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT02200770
• Date of registration: 16/07/2014
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
• Scientific 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
• Date of first enrolment: April 1, 2015
• Target sample size: 231
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02200770
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Bulgaria, Canada, China, Colombia, Czech Republic, Czechia, Estonia, Germany, Greece, Hong Kong, Hungary, India, Israel, Japan, Korea, Republic of, Mexico, Moldova, Republic of, Netherlands, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Intervention(s)

Other: Placebo

Drug: Inebilizumab

Primary Outcome(s)

Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During Randomized Controlled Period (RCP) [Time Frame: Day 1 (Baseline) through Day 197]

Secondary Outcome(s)

Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP [Time Frame: Day 1 (Baseline) through Day 197]

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP) [Time Frame: Pre and post dose on Day 1; and on Days 29, 85, and 197]

Number of Participants With TEAEs and TESAEs During OLP [Time Frame: Day 198 through end of OLP period (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)]

Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab [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)]

Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP [Time Frame: From Screening (Day -28) to Day 197]

Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP) [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)]

Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP) [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)]

Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP [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)]

Number of NMOSD-related In-patient Hospitalizations During RCP [Time Frame: Day 1 (Baseline) through Day 197]

Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP [Time Frame: Day 1 (Baseline) through Day 197]

Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP) [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)]

Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP [Time Frame: Day 1 (Baseline) through Day 197]

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (RCP+OLP) [Time Frame: RCP: Pre and post dose on Day 1; and on Days 29, 85, and 197; OLP: Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months until maximum of 3 years]

Number of Participants With Treatment Emergent Adverse Events TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP [Time Frame: Day 1 (Baseline) through Day 197]

Secondary ID(s)

2014-000253-36

CD-IA-MEDI-551-1155

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/12/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02200770