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Study identifier: NCT04906460 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)

Condition: Duchenne Muscular Dystrophy  ·  Sponsor: Wave Life Sciences USA, Inc.

PhasePhase 1/Phase 2
Planned participants26
Who can joinMale, 4 Years to 18 Years
Healthy volunteersNo

About this study

This is a Phase 1b/2 open-label study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical effects of intravenous (IV) WVE-N531 in patients with Duchenne muscular dystrophy (DMD). To participate in the study, patients must have a documented mutation of the DMD gene that is amenable to exon 53 skipping intervention. This study has 3 parts, Part A, Part B, including Part B Extension Arm, and Part C. Part A is completed. Part B is completed. Following completion of Part B, all patients elected to continue to receive study drug in the optional Part B open-label Extension Arm. Part C has been added to the study and will enroll new patients.

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Operations  ·  855-215-4687  ·  clinicaltrials@wavelifesci.com

Always discuss trial participation with your own doctor first.

Locations (5)

Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
Rare Disease Research LLCAtlanta, Georgia, United StatesRecruiting
Istiklal Hospital/ Clinical Research UnitAmman, JordanRecruiting
The Specialty Hospital (TSH)/ Advanced Clinical CenterAmman, JordanRecruiting
Oxford Children's Hospital, Oxford University Hospitals NHS Foundation TrustHeadington, Oxford, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT04906460