Status:
NOT_YET_RECRUITING
Open-Label Extension Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy
Lead Sponsor:
Wave Life Sciences Ltd.
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
Phase:
PHASE2
Brief 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) ...
Detailed Description
The study will include up to 175 patients from planned and ongoing WVE-N531 studies globally. All patients will continue to receive 10 mg/kg WVE-N531 IV every 4 weeks (Q4W), through Week 96. Safety mo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT07209332
Start Date
November 1 2025
End Date
March 1 2029
Last Update
October 7 2025
Active Locations (3)
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1
Istiklal Hospital/ Clinical Research Unit
Amman, Jordan
2
The Specialty Hospital (TSH)/ Advanced Clinical Center
Amman, Jordan
3
Oxford Children's Hospital, Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, United Kingdom, OX3 9DU