Phase 2 Muscular Dystrophy Trial, Recruiting NCT04906460 Sponsor: Wave Life Sciences USA, Inc. Condition: Muscular Dystrophy
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Phase 2 Muscular Dystrophy Trial, Recruiting

NCT04906460
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Patients who have been diagnosed with Duchenne muscular dystrophy (DMD) based on their symptoms and clinical assessment
  • Patients who have a confirmed genetic change in the DMD gene that can be targeted by a specific type of treatment called "exon 53 intervention"
  • Patients who have some remaining arm and shoulder movement, as measured by a specific upper limb test (a score of 1 or higher on certain shoulder items)
  • Male patients who are either able to walk or unable to walk (Parts A and B), or male patients who are currently able to walk (Part C only)
  • Patients whose lungs are working at 50% or more of the expected level, based on a breathing test
  • Patients whose heart is pumping well enough, confirmed by a heart scan (echocardiogram or cardiac MRI) done within the last 6 months
  • Patients who have enough muscle tissue available for a small muscle sample (biopsy), preferably from the shoulder area
  • Patients who have been on a stable steroid medication for at least 6 months before screening, with no dose changes in the last 3 months
  • Previous participants from Part A may also be eligible for Part B after an 18-week rest period from their last dose

Who may not be able to join:

  • Patients who have another significant health condition (besides DMD) that the doctor believes could make participation unsafe or difficult
  • Patients who have had major surgery within the 3 months before the study starts, or who are planning major surgery at any point during the study (Parts B and C)
  • Patients who have had a diagnosed problem with alcohol, cannabis, or other substance use (except nicotine) within the past 6 months (Part B only)
  • Patients who have used any recreational substances — including prescribed cannabis — within the past 2 months, or who are unwilling to avoid such use for the whole study (Part C only)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, MD, Wave Life Sciences

Phone: 855-215-4687

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Wave Life Sciences USA, Inc.
Registry
ClinicalTrials.gov
Start date
28 September 2021
Est. completion
27 June 2026

Where this trial is recruiting

🇯🇴 Jordan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part A: Safety: Proportion of patients with adverse events (AEs); Part B: Pharmacodynamics: Dystrophin level (% normal dystrophin) as assessed by Western blot of muscle tissue following multiple doses of WVE-N531; Part C: Pharmacodynamics: Change from baseline dystrophin level (% normal dystrophin) as assessed by a validated assay analysis in muscle tissue following multiple doses of WVE-N531

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov