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NCT07160634 · ClinicalTrials.gov registry record · Phase 3
A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)
A Phase 3 study, sponsored by Solid Biosciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT07160634: Recruiting Phase 3 study, sponsored by Solid Biosciences.
NCT07160634 is a Phase 3 study that is actively recruiting participants, run by Solid Biosciences. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07160634, a Phase 3 study, is actively recruiting participants, sponsored by Solid Biosciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
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
- DRUG Placebo
- DRUG SGT-003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-10-22 |
| Est. Completion | 2034-01 |
| Phase | Phase 3 |
What NCT07160634 shows while recruiting
NCT07160634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07160634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07160634 about?
NCT07160634 is a clinical study titled "A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)". 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 w...
What is the current status of trial NCT07160634?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2025-10-22. Estimated completion is 2034-01.
What interventions are being tested in trial NCT07160634?
The interventions under investigation include: Placebo (DRUG), SGT-003 (DRUG).
Who is sponsoring clinical trial NCT07160634?
This trial is sponsored by Solid Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07160634's enrollment target sits among peer trials
80 1755th of 2000 higher than 233 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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