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Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | Clinical Trials | Clareo Health

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

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

NCT01423110•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - 80 years

Sex

ALL

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

Locations (3)

Novartis Investigative Site

Scottsdale, Arizona, United States

Novartis Investigative Site

Kansas City, Kansas, United States

Novartis Investigative Site

Boston, Massachusetts, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

December 17, 2020

Enrollment

ACTUAL participants

Conditions

Sporadic Inclusion Body Myositis

Interventions

BYM338

BIOLOGICAL

Placebo

BIOLOGICAL

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UNKNOWN

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Sporadic Inclusion Body Myositis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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