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

NCT01423110 — Phase 2, Completed, 14 participants, Novartis Pharmaceuticals
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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

RegistryNCT01423110
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment14 (Actual)
SponsorNovartis Pharmaceuticals (Industry)
ConditionsSporadic Inclusion Body Myositis
InterventionsBYM338, Placebo (Biological)
Datesstart 2011-08-01, primary completion 2012-05-01, completion 2012-05-01, first posted 2011-08-25, last updated 2020-12-17
Locations3 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Sporadic Inclusion Body Myositis All trials of BYM338 All trials of Placebo

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
BYM338ExperimentalBiological: BYM338
PlaceboPlacebo comparatorBiological: Placebo
  • BYM338 (Biological)
  • Placebo (Biological)

+Outcome measures

Primary outcomes

  • Effect of BYM338 on Thigh Muscle Volume by MRI [8 weeks]: Change in thigh muscle volume

Secondary outcomes

  • Effect of BYM338 on muscle function by 'Timed Get Up and Go' test [8 weeks]: Change in muscle function measured on scale by test results

+Eligibility

Sex: All, ages: 40 Years to 80 Years

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

+Locations (3)

FacilityCityCountryStatus
Novartis Investigative SiteScottsdale, ArizonaUnited States
Novartis Investigative SiteKansas City, KansasUnited States
Novartis Investigative SiteBoston, MassachusettsUnited States

+Publications

  • Results publication: 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. PMID 25381300

+Investigators

  • Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals