Back to results

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

Primary Purpose

Sporadic Inclusion Body Myositis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BYM338

Placebo

About this trial

This is an interventional treatment trial for Sporadic Inclusion Body Myositis focused on measuring sporadic Inclusion Body Myositis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BYM338

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Effect of BYM338 on Thigh Muscle Volume by MRI

Change in thigh muscle volume

Secondary Outcome Measures

Effect of BYM338 on muscle function by 'Timed Get Up and Go' test

Change in muscle function measured on scale by test results

Full Information

NCT ID

NCT01423110

First Posted

August 12, 2011

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01423110

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sporadic Inclusion Body Myositis

Keywords

sporadic Inclusion Body Myositis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BYM338

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

BYM338

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Effect of BYM338 on Thigh Muscle Volume by MRI

Description

Change in thigh muscle volume

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Effect of BYM338 on muscle function by 'Timed Get Up and Go' test

Description

Change in muscle function measured on scale by test results

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Scottsdale

State/Province

Arizona

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Kansas

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25381300

Citation

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.

Results Reference

result

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10243

Description

Results for CBYM338X2205 from the Novartis Clinical Trials website

Learn more about this trial

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

We'll reach out to this number within 24 hrs