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A Phase 1b randomized, double-blind placebo-controlled study of ENTR-601-44 non-ambulatory and ambulatory adult patients with DMD who are exon 44 skipping amenable

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Trial Profile

A Phase 1b randomized, double-blind placebo-controlled study of ENTR-601-44 non-ambulatory and ambulatory adult patients with DMD who are exon 44 skipping amenable

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs ENTR-601-44 (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions
  • Acronyms ELEVATE-44-102

    • Most Recent Events

    • 27 Feb 2025 According to an Entrada Therapeutics media release, the company have submitted regulatory filings to initiate a global Phase 1/2 MAD clinical study of ENTR-601-45 ,also on a track to initiate ELEVATE-44-201 in the U.K. in Q2 2025.
    • 26 Feb 2025 New trial record
    • 24 Feb 2025 According to an Entrada Therapeutics media release, company announced that the United States Food and Drug Administration has lifted the clinical hold on ENTR-601-44 and provided Medicines and Healthcare Products Regulatory Agency authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping.

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