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NCT06411288 · ClinicalTrials.gov registry record · Phase 3

Global Study of Del-desiran for the Treatment of DM1

A Phase 3 study of Myotonic Dystrophy and Myotonic Dystrophy 1, sponsored by Avidity Biosciences.

Active
Registry status
Phase 3
Development phase
159
Enrollment target
20
Study locations

NCT06411288 is a Phase 3 study of Myotonic Dystrophy and Myotonic Dystrophy 1 that is active but no longer recruiting, run by Avidity Biosciences. The registered enrollment target is 159 participants, below the 838-participant average among 9 other Myotonic Dystrophy trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT06411288, a Phase 3 study of Myotonic Dystrophy and Myotonic Dystrophy 1, is active but no longer recruiting, sponsored by Avidity Biosciences.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
159 participants
Enrollment target
20
Study locations

Study Summary

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Global Study to Evaluate the Efficacy and Safety of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC 1001) for the Treatment of Myotonic Dystrophy Type 1

Conditions Studied

Myotonic Dystrophy Myotonic Dystrophy 1 DM1 Myotonic Dystrophy Type 1 (DM1) Myotonic Muscular Dystrophy Myotonic Disorders Myotonia Dystrophy Myotonic Steinert Disease Steinert

Interventions

  • DRUG Placebo
  • DRUG AOC 1001 (del-desiran)

Study Locations (20)

Florida

  • University of Florida - Gainesville
  • University Research Center of South Florida - Tampa

North Carolina

  • Duke University Medical Center - Durham
  • Wake Forest - Winston-Salem

Ohio

  • University of Cincinnati Gardner Neuroscience Institute - Cincinnati
  • Ohio State University - Columbus

California

  • Stanford University - Stanford

Colorado

  • University of Colorado - Denver

Indiana

  • Indiana University (IU) - Indianapolis

Kansas

  • Kansas University Medical Center - Kansas City

Maryland

  • Kennedy Krieger Institute - Baltimore

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2024-05-30
Est. Completion 2026-09
Phase Phase 3

Sponsor

Avidity Biosciences

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06411288

The ClinicalTrials.gov registry entry for NCT06411288 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 838-participant average among 9 other Myotonic Dystrophy trials with a reported enrollment target (81% lower). The listed sponsor is Avidity Biosciences, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Myotonic Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06411288 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Florida, North Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT06411288 about?

NCT06411288 is a clinical study titled "Global Study of Del-desiran for the Treatment of DM1". A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Global Study to Evaluate the Efficacy and Safety of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC 1001) for the Treatment of Myotonic Dystrophy Type 1

What is the current status of trial NCT06411288?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 159 participants. The study started on 2024-05-30. Estimated completion is 2026-09.

What conditions does trial NCT06411288 study?

This clinical trial studies the following conditions: Myotonic Dystrophy, Myotonic Dystrophy 1, DM1, Myotonic Dystrophy Type 1 (DM1), Myotonic Muscular Dystrophy.

What interventions are being tested in trial NCT06411288?

The interventions under investigation include: Placebo (DRUG), AOC 1001 (del-desiran) (DRUG).

Who is sponsoring clinical trial NCT06411288?

This trial is sponsored by Avidity Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06411288 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.