A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis

Completed
Phase of Trial: Phase II/III

Latest Information Update: 17 May 2017

At a glance

  • Drugs Bimagrumab (Primary)
  • Indications Inclusion body myositis
  • Focus Registrational; Therapeutic Use
  • Acronyms RESILIENT
  • Sponsors Novartis
  • Most Recent Events

    • 28 Apr 2017 Results presented at the 69th Annual Meeting of the American Academy of Neurology
    • 16 Nov 2016 Results presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals
    • 21 Apr 2016 Primary endpoint has not been met. (Change from Baseline in 6 Minute Walking Distance Test (6MWD) meters to , as per Morphosys media release.
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