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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Chugai Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02073279
First received: February 25, 2014
Last updated: July 7, 2016
Last verified: July 2016
  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: SA237
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 27 months from first patient in ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annualized relapse rate [ Time Frame: up to approximately 38 months from first patient in ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SA237
Subcutaneous SA237
Drug: SA237
Placebo Comparator: Placebo
Subcutaneous placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073279

Contacts
Contact: Clinical trials information clinical-trials@chugai-pharm.co.jp

  Show 40 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 
Study First Received: February 25, 2014
Last Updated: July 7, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 25, 2016