Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Sporadic Inclusion Body Myositis

Eligibility:

All Genders

40-80 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2012

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT01423110

Start Date

August 1 2011

End Date

May 1 2012

Last Update

December 17 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Novartis Investigative Site

Scottsdale, Arizona, United States

2

Novartis Investigative Site

Kansas City, Kansas, United States

3

Novartis Investigative Site

Boston, Massachusetts, United States