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

NCT02200770 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2021-12-03

Study results available
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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.

Conditions

  • Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Interventions

DRUG

Inebilizumab

Participants will receive IV inebilizumab 300 mg.

OTHER

Placebo

Participants will receive IV placebo matched to inebilizumab.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • MedImmune, LLC MedImmune, LLC · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2018-10-26
Completion
2020-11-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Estonia
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Japan
  • Mexico
  • Moldova
  • New Zealand
  • Peru
  • Poland
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02200770 on ClinicalTrials.gov