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RECRUITING
NCT07587242
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

AOC 1044

AOC 1044 will be administered by intravenous (IV) infusion

DRUG

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