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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.
 
ClinicalTrials.gov Identifier: NCT01423110
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE August 12, 2011
First Posted Date  ICMJE August 25, 2011
Last Update Posted Date August 27, 2020
Study Start Date  ICMJE August 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2012)
Effect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ]
Change in thigh muscle volume
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
Measure: To assess the affect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2012)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
Measure: To assess the effect of BYM338 on muscle function by 'Timed Get Up and Go' test [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
Official Title  ICMJE 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
Brief Summary This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sporadic Inclusion Body Myositis
Intervention  ICMJE
  • Biological: BYM338
  • Biological: Placebo
Study Arms  ICMJE
  • Experimental: BYM338
    Intervention: Biological: BYM338
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications * Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, Lach-Trifilieff E, Trendelenburg AU, Laurent D, Glass DJ, Roubenoff R, Tseng BS, Greenberg SA. Treatment of sporadic inclusion body myositis with bimagrumab. Neurology. 2014 Dec 9;83(24):2239-46. doi: 10.1212/WNL.0000000000001070. Epub 2014 Nov 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2012)
14
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2011)
12
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01423110
Other Study ID Numbers  ICMJE CBYM338X2205
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP