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A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping

NCT07587242 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-14

No results posted yet for this study

Summary

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping

Conditions

  • Muscular Dystrophies
  • Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)
  • Muscular Disorders, Atrophic
  • Muscular Disease
  • Musculoskeletal Diseases
  • Neuromuscular Diseases (NMD)
  • Nervous System Diseases
  • Genetic Diseases
  • X-Linked
  • Hereditary
  • Neonatal Disease
  • Duchene Muscular Dystrophy
  • Congenital
  • DMD

Interventions

DRUG

AOC 1044

AOC 1044 will be administered by intravenous (IV) infusion

DRUG

Placebo

Placebo will be administered by intravenous (IV) infusion

Sponsors & Collaborators

  • Avidity Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
16 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-05-31
Completion
2030-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587242 on ClinicalTrials.gov