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

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. Identifier: NCT01423110
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : December 17, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis

Condition or disease Intervention/treatment Phase
Sporadic Inclusion Body Myositis Biological: BYM338 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: BYM338 Biological: BYM338
Placebo Comparator: Placebo Biological: Placebo

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01423110

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01423110    
Other Study ID Numbers: CBYM338X2205
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
sporadic Inclusion Body Myositis
Additional relevant MeSH terms:
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Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases