Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Chugai Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02028884
First received: January 6, 2014
Last updated: February 25, 2014
Last verified: February 2014
  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)
NMO Spectrum Disorder (NMOSD)
Drug: SA237
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, Addition to Baseline Treatment, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 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 30 months from first patient in ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annualized relapse rate [ Time Frame: up to approximately 30 months from first patient in ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: February 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SA237
Subcutaneous SA237
Drug: SA237
Placebo Comparator: Placebo
Subcutaneous placebo

  Eligibility

Ages Eligible for Study:   12 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. NMO or NMOSD
  2. Age 12 to 74 years, inclusive at the time of informed consent.

Exclusion Criteria

  1. Pregnancy or lactation.
  2. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (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: NCT02028884

Contacts
Contact: Clinical trials information clinical-trials@chugai-pharm.co.jp
Contact: SA237 Clinical trial sa237@chugai-pharm.co.jp

Locations
Japan
Recruiting
Kansai region, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Akinori Yamada Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT02028884     History of Changes
Other Study ID Numbers: SA-307JG, 2013-003752-21
Study First Received: January 6, 2014
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014