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Efficacy and Safety Study as Monotherapy of SA237 to Treat NMO and NMOSD

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073279
First Posted: February 27, 2014
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chugai Pharmaceutical
  Purpose
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD

Condition Intervention Phase
Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) Drug: satralizumab (SA237) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Time to first relapse [ Time Frame: up to approximately 38 months from first patient in ]

Secondary Outcome Measures:
  • Annualized relapse rate [ Time Frame: up to approximately 38 months from first patient in ]

Enrollment: 95
Study Start Date: August 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: satralizumab (SA237)
Subcutaneous satralizumab (SA237)
Drug: satralizumab (SA237)
Placebo Comparator: Placebo
Subcutaneous placebo
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. Pregnancy or lactation.
  • 2. Evidence of other demyelinating disease or PML.
  • 3. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073279


  Show 77 Study Locations
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Athos Gianella-Borradori, MD. Chugai Pharmaceutical
  More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT02073279     History of Changes
Other Study ID Numbers: SA-309JG
First Submitted: February 25, 2014
First Posted: February 27, 2014
Last Update Posted: October 31, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neuromyelitis Optica
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases