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Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)

NCT07608432 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-27

No results posted yet for this study

Summary

The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment rostudirsen (DYNE-251) administered intravenously (IV) every 4 weeks to ambulatory Duchenne muscular dystrophy (DMD) participants, 4 to 18 years of age, with dystrophin mutations amenable to exon 51 skipping.

Conditions

  • Duchenne Muscular Dystrophy (DMD)
  • Muscular Dystrophy, Duchenne
  • Muscular Dystrophy (DMD)
  • DMD
  • Muscular Dystrophies
  • Muscular Dystrophy in Children
  • Muscular Dystrophy, Duchenne Type
  • Muscular Dystrophy, Duchenne and Becker Types
  • Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)
  • Genetic Disease, Inborn
  • Genetic Disease, X-Linked
  • Congenital, Hereditary, and Neonatal Diseases and Abnormalities
  • Neuromuscular Diseases (NMD)

Interventions

DRUG

Zeleciment Rostudirsen (DYNE-251)

Administered by IV infusion

DRUG

Placebo

Administered by IV infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-12-31
Completion
2032-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608432 on ClinicalTrials.gov