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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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