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

Study identifier:CD-IA-MEDI-551-1155

ClinicalTrials.gov identifier:NCT02200770

EudraCT identifier:2014-000253-36

CTIS identifier:N/A

Study Complete

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.

Medical condition

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Phase

Phase 2/3

Healthy volunteers

Study drug

Inebilizumab

Sex

All

Actual Enrollment

231

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Apr 2015

Primary Completion Date: 26 Oct 2018

Study Completion Date: 06 Nov 2020

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2021 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1.Men and women 18 years or older with diagnosis of NMO/NMOSD
2.Confirmation of NMO/NMOSD status:
a.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
b.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:
a.Alemtuzumab
b.Total lymphoid irradiation
c.Bone marrow transplant
d.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:
a.Natalizumab (Tysabri®).
b.Cyclosporin
c.Methotrexate
d.Mitoxantrone
e.Cyclophosphamide
f.Tocilizumab
g.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

No locations available

Arms	Assigned Interventions
Placebo Comparator: Placebo/Inebilizumab 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.	Drug: Inebilizumab Participants will receive IV inebilizumab 300 mg. Other Name: MEDI-551 Other: Placebo Participants will receive IV placebo matched to inebilizumab.
Experimental: Inebilizumab/Inebilizumab 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.	Drug: Inebilizumab Participants will receive IV inebilizumab 300 mg. Other Name: MEDI-551 Other: Placebo Participants will receive IV placebo matched to inebilizumab.

Arms

Assigned Interventions

Placebo Comparator: Placebo/Inebilizumab
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.

Drug: Inebilizumab
Participants will receive IV inebilizumab 300 mg.

Other Name: MEDI-551

Other: Placebo
Participants will receive IV placebo matched to inebilizumab.

Experimental: Inebilizumab/Inebilizumab
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.

Drug: Inebilizumab
Participants will receive IV inebilizumab 300 mg.

Other Name: MEDI-551

Other: Placebo
Participants will receive IV placebo matched to inebilizumab.

Documents available

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CD-IA-MEDI-551-1155&attachmentIdentifier=ae7e7dac-afeb-4a4e-bf68-5ce2e36292b8&fileName=statistical_analysis_plan_cd-ia-medi-551-1155_amendment_4-redacted_PDFA.pdf&versionIdentifier=
Download
CD-IA-MEDI-551-1155 Redacted Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

MedImmune, LLC MedImmune, LLC

MedImmune, LLC