HomeTrialNCT07160634
🔬NCT07160634Phase 3RECRUITING

A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)

Study Summary

This is a Phase 3, double-blind, placebo-controlled study with the primary objective of evaluating the efficacy of a single IV infusion of SGT-003 in pediatric ambulant male participants with DMD. The secondary objectives include the evaluation of additional efficacy and safety outcomes. The study will be divided into 2 parts. Participants will be randomized 1:1 to either SGT-003 in Part 1 followed by placebo in Part 2 or to placebo in Part 1 followed by SGT-003 in Part 2. Participants will continue to be monitored in long term follow up (LTFU) for at least 5 years from their SGT-003 dosing date.

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment80 participants
Primary Completion
Lead SponsorSolid Biosciences Inc.
Data Retrieved2026-04-11 04:27:33.472569+00:00
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