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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 June 2017 by Chugai Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02028884
First received: January 6, 2014
Last updated: June 5, 2017
Last verified: June 2017
  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 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, 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 ]

Secondary Outcome Measures:
  • Annualized relapse rate [ Time Frame: up to approximately 30 months from first patient in ]

Estimated Enrollment: 70
Study Start Date: February 2014
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: September 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

Detailed Description:
Recruitment is closed to adults. Recruitment is open to adolescents 12-17 years old.
  Eligibility

Ages Eligible for Study:   12 Years to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 54 Study Locations
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Akinori Yamada Chugai Pharmaceutical
  More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT02028884     History of Changes
Other Study ID Numbers: SA-307JG
2013-003752-21 ( EudraCT Number )
Study First Received: January 6, 2014
Last Updated: June 5, 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

ClinicalTrials.gov processed this record on September 21, 2017