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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 is a Phase 3 study that is actively recruiting participants, run by Solid Biosciences. The registered enrollment target is 80 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07160634
The ClinicalTrials.gov registry entry for NCT07160634 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Solid Biosciences, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07160634 reports 0 study locations.
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.
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