Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-251 in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
← catalyst calendarNCT05524883 · readout ≤ 1,867 d
Sponsored by Dyne Therapeutics (industry) · DYN — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
86actual
Sites
30
Countries
Australia, Belgium, Canada +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-12 | actual | When the study began enrolling |
| Primary completion | Sep 2031 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Duchenne Muscular Dystrophy (DMD)
Interventions
- Drug: DYNE-251
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)
measured Through study completion, up to Week 337
Change From Baseline in Dystrophin Protein Levels in Muscle Tissue at Week 25
measured Baseline, Week 25
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