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

Sporadic Inclusion Body Myositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423110
• Other study ID #: CBYM338X2205
• Status: Completed
• Phase: Phase 2
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Myositis
• Myositis, Inclusion Body
• Sporadic Inclusion Body Myositis

Intervention

Biological:
• BYM338

• Placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Kansas City	Kansas
United States	Novartis Investigative Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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(2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of BYM338 on Thigh Muscle Volume by MRI	Change in thigh muscle volume	8 weeks
Secondary	Effect of BYM338 on muscle function by 'Timed Get Up and Go' test	Change in muscle function measured on scale by test results	8 weeks

External Links

•   Results for CBYM338X2205 from the Novartis Clinical Trials website