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A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06252616 IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY

Trial Profile

A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06252616 IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 20 Sep 2022

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At a glance

  • Drugs Domagrozumab (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms CHIL3382
  • Sponsors Pfizer
  • Most Recent Events

    • 14 Sep 2022 Data from this study and other phase 1 study (NCT01616277) was sought to establish the PK/PD relationship between free domagrozumab and total myostatin concentrations in pediatric patients with DMD using a prior semi-mechanistic model, published in the Clinical Pharmacology and Therapeutics
    • 01 Aug 2022 Results assessing use of quantitative magnetic resonance imaging (MRI) measures as biomarkers , published in the Journal of Neurology.
    • 04 Dec 2018 Planned End Date changed from 23 Nov 2018 to 1 Dec 2018.
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