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NCT06138639 · ClinicalTrials.gov registry record · Phase 1

A Study of SGT-003 Gene Therapy in Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)

A Phase 1 study of Duchenne Muscular Dystrophy, sponsored by Solid Biosciences.

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
15
Study locations

NCT06138639 is a Phase 1 study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Solid Biosciences. The registered enrollment target is 60 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (85% lower). The trial reports 15 study locations across 12 states.

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The verdict

NCT06138639, a Phase 1 study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Solid Biosciences.

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
15
Study locations

Study Summary

This is a multicenter, open-label, non-randomized study to investigate the safety, tolerability, and efficacy of a single intravenous (IV) infusion of SGT-003 in participants with Duchenne muscular dystrophy. There will be 5 cohorts in this study. Cohort 1 will include participants 4 to \< 7 years of age. Cohort 2 will include participants 7 to \< 12 years of age. Cohort 3 will include participants 0 to \< 4 years of age. Cohort 4 will include participants 12 to \< 18 years of age. Cohort 5 will include participants 10 to \< 18 years of age. Initiation of participant enrollment in Cohorts 4 and 5 will be subject to the accrual of safety and efficacy data from Cohorts 1-3. All participants will receive SGT-003 and will be enrolled in the study for 5 total years for long-term follow up.

Conditions Studied

Duchenne Muscular Dystrophy

Interventions

  • GENETIC SGT-003

Study Locations (15)

California

  • University of California, Los Angeles Medical Center - Los Angeles
  • University of California, Davis - Sacramento
  • University of California - San Diego

Other

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Rome
  • Great Ormond Street Hospital - London

Arkansas

  • Arkansas Children's Hospital - Little Rock

Georgia

  • Rare Disease Research - Atlanta

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago

Missouri

  • Washington University in St. Louis - St Louis

Ohio

  • Nationwide Children's Hospital - Columbus

Oregon

  • Oregon Health and Sciences University - Portland

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-05-06
Est. Completion 2031-05-06
Phase Phase 1

Sponsor

Solid Biosciences

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06138639

The ClinicalTrials.gov registry entry for NCT06138639 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (85% lower). The listed sponsor is Solid Biosciences, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which SGT-003 is the first listed.

NCT06138639 reports 15 study locations spanning 12 distinct geographic areas - top geographies include California, Other, Arkansas.

Frequently Asked Questions

What is clinical trial NCT06138639 about?

NCT06138639 is a clinical study titled "A Study of SGT-003 Gene Therapy in Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)". This is a multicenter, open-label, non-randomized study to investigate the safety, tolerability, and efficacy of a single intravenous (IV) infusion of SGT-003 in participants with Duchenne muscular dystrophy. There will be 5 cohorts in this study. Cohort 1 will include participants 4 to \< 7 years o...

What is the current status of trial NCT06138639?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-05-06. Estimated completion is 2031-05-06.

What conditions does trial NCT06138639 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.

What interventions are being tested in trial NCT06138639?

The interventions under investigation include: SGT-003 (GENETIC).

Who is sponsoring clinical trial NCT06138639?

This trial is sponsored by Solid Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06138639 being conducted?

This trial has 15 study locations across Arkansas, California, Georgia, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.