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Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01423110
First Posted: August 25, 2011
Last Update Posted: February 23, 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):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis

Condition Intervention Phase
Sporadic Inclusion Body Myositis Biological: BYM338 Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Effect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ]
    Change in thigh muscle volume


Secondary Outcome Measures:
  • Effect of BYM338 on muscle function by 'Timed Get Up and Go' test [ Time Frame: 8 weeks ]
    Change in muscle function measured on scale by test results


Enrollment: 14
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BYM338 Biological: BYM338
Placebo Comparator: Placebo Biological: Placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis

Exclusion Criteria:

  • Unable to walk at least 3 meters without assistance from another person
  • Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months
  • patients with a history or presence of renal impairment and/or liver disease

Other protocol-defined inclusion/exclusion criteria may apply

  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): NCT01423110


Locations
United States, Arizona
Novartis Investigative Site
Scottsdale, Arizona, United States
United States, Kansas
Novartis Investigative Site
Kansas City, Kansas, United States
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01423110     History of Changes
Other Study ID Numbers: CBYM338X2205
First Submitted: August 12, 2011
First Posted: August 25, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
sporadic Inclusion Body Myositis

Additional relevant MeSH terms:
Myositis
Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Antibodies, Monoclonal
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs