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Zeleciment Rostudirsen

Phase 3

Duchenne Muscular Dystrophy (DMD) | Small molecule | Rare Disease |Dyne Therapeutics, Inc.|Last Updated: May 27, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical trial landscape

Zeleciment Rostudirsen · 1 trial · 13 indications

Phase 3 1
NCT07608432Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)Duchenne Muscular Dystrophy (DMD)
RECRUITING90 Analytics
PHASE3RECRUITING
Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)
Duchenne Muscular Dystrophy (DMD)
NCT0760843290
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Study Endpoints
Primary Endpoints
Rise From Floor (RFF) velocity
Baseline, Week 73
Secondary Endpoints
RFF (Rise From Floor) velocity
Baseline, up to Week 169
Stride Velocity 95th Percentile (SV95C)
Baseline, Week 73, up to Week 169
North Star Ambulatory Assessment (NSAA) Total Score
Baseline, Week 73, up to Week 169
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo-Controlled Period: Zeleciment Rostudirsen (DYNE-251)EXPERIMENTALParticipants will be randomized to receive zeleciment rostudirsen, once every 4 weeks (Q4W) for up to 72 weeks.
Placebo-Controlled Period: PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive placebo, Q4W for up to 72 weeks.
Open-Label Long-Term Extension Period: Zeleciment Rostudirsen (DYNE-251)EXPERIMENTALAll participants who complete the Placebo-Controlled Period of the study will receive zeleciment rostudirsen administered Q4W for up to 96 weeks.
Interventions
NameTypeDescription
Zeleciment Rostudirsen (DYNE-251)DRUGAdministered by IV infusion
PlaceboDRUGAdministered by IV infusion
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Eligibility Criteria
Age Range4 Years to 18 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Ambulatory male with confirmed diagnosis of DMD and with a mutation in the dystrophin gene characterized by exon deletion amenable to exon 51 skipping . * Rise From Floor (RFF) time must be \< 10 seconds for both screening assessments . * Receiving a stable daily or weekend do...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT07608432NEW_TRIAL: changed
LOWMay 28, 2026NCT07608432NEW_TRIAL: changed