NCT07209332Enrolling by invitationPhase 2
Open-Label Extension Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy
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
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 28 Dec 2025
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Wave Life Sciences USA, Inc.
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT07209332
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 175
- From 28 Dec 2025 to the primary completion date, 31 Mar 2029
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any clinically significant medical finding or change during or following participation in the prior WVE-N531 study, other than DMD that, in the judgment of the Investigator, would affect the potential safety of the patient to receive WVE-N531 or interfere with participation in the study.
- Any recreational substance use (including prescribed cannabinoids), with the exception of alcohol and nicotine, irrespective of legality, within 2 months prior to FD and/or unwilling to refrain from such use for the duration of the study.
Who the study is looking for
- Participated in a prior study of WVE-N531 and has not experienced any significant toxicities due to WVE-N531 or significant clinical deterioration of general health since the last dose or early discontinuation visit.
- Of note: if there will be a greater than 31-day gap between the last dose on the prior study and the FD on this study, the case should be discussed between the Investigator and Medical Monitor.
Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oxford Children's Hospital, Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Headington | United Kingdom | Unknown status |
| Istiklal Hospital/ Clinical Research Unit Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
| The Specialty Hospital (TSH) / Advanced Clinical Center Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.