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ENROLLING BY INVITATION
NCT07209332
PHASE2

Open-Label Extension Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy

Sponsor: Wave Life Sciences Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase 2 open-label extension (OLE) study to evaluate the long-term safety, tolerability, efficacy, pharmacokinetics, and the pharmacodynamics (PD) through potential exploratory biomarker(s) of intravenous (IV) WVE-N531 in patients with DMD who participated in another study of WVE-N531. All patients will have rolled over from a previous study of WVE-N531.

Official title: An Open-Label Extension Study to Investigate the Long-term Safety, Tolerability, Pharmacokinetics, and Efficacy of WVE-N531 in Patients With Duchenne Muscular Dystrophy Who Participated in Another Study of WVE-N531

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

175

Start Date

2025-12-28

Completion Date

2029-03

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

WVE-N531

WVE-N531 is an antisense oligonucleotide (ASO)

Locations (3)

Istiklal Hospital/ Clinical Research Unit

Amman, Jordan

The Specialty Hospital (TSH)/ Advanced Clinical Center

Amman, Jordan

Oxford Children's Hospital, Oxford University Hospitals NHS Foundation Trust

Headington, Oxford, United Kingdom