Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Chugai Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02073279
First received: February 25, 2014
Last updated: February 6, 2015
Last verified: February 2015
  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
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 27 months from first patient in ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 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:   18 Years to 74 Years
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
Contact: SA237 Clinical trial sa237@chugai-pharm.co.jp

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Neurology Associate Group Recruiting
Miami, Florida, United States, 33155
Negroski, Sutherland & Hanes Neurology, LLP Recruiting
Sarasota, Florida, United States, 34239
Vero Neurology Recruiting
Vero Beach, Florida, United States, 32960
United States, Georgia
Columbus Research & Wellness Clinic Recruiting
Columbus, Georgia, United States, 31909
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Consultants in Neurology, Ltd. Recruiting
Northbrook, Illinois, United States, 60062
University of Illinois College of Medicine / Illinois Neurologic Institute Recruiting
Peoria, Illinois, United States, 61606
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Rowe Neurology Institute Recruiting
Lenexa, Kansas, United States, 66214
United States, New York
South Shore Neurologic Associates Recruiting
Patchogue, New York, United States, 11772
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
The Neurological Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
Ohio Health Neurological Physicians Recruiting
Columbus, Ohio, United States, 43221
United States, Oklahoma
OMRF Multiple Sclerosis Center of Excellence Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Health Systems / Oregon Neurology, PC Recruiting
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Thomas Jefferson University, The Comprehensive MS Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
University of Texas Southwestern Medical School Not yet recruiting
Dallas, Texas, United States, 75235
Central Texas Neurology Consultants Recruiting
Round Rock, Texas, United States, 78681
UT Medicine San Antonio Recruiting
San Antonio, Texas, United States, 78229
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Puerto Rico
Caribbean Neurological Center Centro Internacional de Mercadeo Recruiting
Guaynabo, Puerto Rico, 00968
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Athos Gianella-Borradori, MD. Chugai Pharmaceutical
  More Information

No publications provided

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: February 6, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 02, 2015