RecruitingPhase 3NCT07587242

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

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


Sponsor

Avidity Biosciences, Inc.

Enrollment

70 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 7 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AOC 1044 and a drug called Placebo for people with congenital, dmd, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include men aged 7 Years to 16 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAOC 1044

AOC 1044 will be administered by intravenous (IV) infusion

DRUGPlacebo

Placebo will be administered by intravenous (IV) infusion


Locations(13)

UZ Leuven

Leuven, Belgium

Centre Hospitalier Régional de la Citadelle

Liège, Belgium

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

University of Oxford and Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07587242


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