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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01423110
First received: August 12, 2011
Last updated: August 16, 2012
Last verified: August 2012
  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: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Effect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01423110     History of Changes
Other Study ID Numbers: CBYM338X2205
Study First Received: August 12, 2011
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
sporadic Inclusion Body Myositis

Additional relevant MeSH terms:
Myositis
Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014