Summary

for people ages 18-74 (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Keywords

Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)Neuromyelitis Opticasatralizumab (SA237)

Eligibility

You can join if…

Open to people ages 18-74

    1. NMO or NMOSD
    1. Age 18 to 74 years, inclusive at the time of informed consent.

You CAN'T join if...

    1. Pregnancy or lactation.
    1. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
    1. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.

Locations

  • University of California, Irvine
    IrvineCalifornia92697United States
  • UC Davis Medical System
    SacramentoCalifornia95817-2307United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02073279
Phase
Phase 3
Study Type
Interventional
Last Updated