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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
Sponsor: Avidity Biosciences, Inc.
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
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (Delpacibart Zotadirsen) for the Treatment of DMD With Gene Mutations Amenable to Exon 44 Skipping
Key Details
Gender
MALE
Age Range
7 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-08
Completion Date
2030-07
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
AOC 1044
AOC 1044 will be administered by intravenous (IV) infusion
Placebo
Placebo will be administered by intravenous (IV) infusion
Locations (10)
AP-HP Hospital Armand-Trousseau
Paris, France
Universitaetsklinikum Essen
Essen, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Germany
Fondazione Serena ETS - Centro Clinico NeMO Milano
Milan, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universitario Cattolica del Sacro Cuore
Roma, Italy
Hospital Sant Joan de Deu
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Viamed Santa Angela De la Cruz - FutureMeds Spain
Seville, Spain
Royal Victoria Infirmary
Newcastle, United Kingdom