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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2011

Last Updated Date

August 16, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Change in thigh muscle volume

Original Primary Outcome Measures ^ICMJE

Measure: To assess the affect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01423110 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Measure: To assess the effect of BYM338 on muscle function by 'Timed Get Up and Go' test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Sporadic Inclusion Body Myositis

Intervention ^ICMJE

Biological: BYM338
Biological: Placebo

Study Arm (s)

Experimental: BYM338
Intervention: Biological: BYM338
Placebo Comparator: Placebo
Intervention: Biological: Placebo

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

May 2012

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

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01423110

Other Study ID Numbers ^ICMJE

CBYM338X2205

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

August 2012

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

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