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

Sponsor
Wave Life Sciences USA, Inc.
Study ID
NCT07209332
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • WVE-N531 — DRUG
    WVE-N531 is an antisense oligonucleotide (ASO)

Study Details

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.

Key Dates

Start date
Dec 28, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
175 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: WVE-N531

Primary Outcome Measure

Number of participants with treatment related adverse events as assessed by the following parameters: [ Time Frame: Time Frame: Week 0 through Week 96 ]

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