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NCT07038200 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD

A Phase 3 study of Facioscapulohumeral Muscular Dystrophy and FSHD, sponsored by Avidity Biosciences.

Recruiting
Registry status
Phase 3
Development phase
200
Enrollment target
20
Study locations

NCT07038200: Recruiting Phase 3 study of Facioscapulohumeral Muscular Dystrophy and FSHD, sponsored by Avidity Biosciences.

NCT07038200 is a Phase 3 study of Facioscapulohumeral Muscular Dystrophy and FSHD that is actively recruiting participants, run by Avidity Biosciences. The registered enrollment target is 200 participants, below the 1,479-participant average among 6 other Facioscapulohumeral Muscular Dystrophy trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07038200, a Phase 3 study of Facioscapulohumeral Muscular Dystrophy and FSHD, is actively recruiting participants, sponsored by Avidity Biosciences.

RECRUITING
Registry status
Phase 3
Development phase
200 participants
Enrollment target
20
Study locations

Study Summary

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

Primary Outcome

Assessment of muscle strength using standardized quantitative measurements

Conditions Studied

Facioscapulohumeral Muscular Dystrophy FSHD Fascioscapulohumeral Muscular Dystrophy FSHD - Facioscapulohumeral Muscular Dystrophy FSHD1 FSHD2 Facioscapulohumeral Muscular Dystrophy 1 Fascioscapulohumeral Muscular Dystrophy Type 1 Fascioscapulohumeral Muscular Dystrophy Type 2 Facioscapulohumeral Dystrophy

Interventions

  • DRUG Placebo
  • DRUG AOC-1020

Study Locations (20)

California

  • University of California Irvine - Orange
  • Stanford University - Palo Alto

Alberta

  • University of Calgary - Cumming School of Medicine - Calgary
  • University of Alberta Hospital - Edmonton

Other

  • National Hospital Organization Osaka Toneyama Medical Center - Osaka
  • The University of Osaka Hospital - Osaka

Colorado

  • University of Colorado - Denver

Florida

  • University of Florida - Gainesville

Iowa

  • University of Iowa - Iowa City

Kansas

  • Kansas University Medical Center - Kansas City

Maryland

  • Kennedy Krieger Institute - Baltimore

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2025-06-10
Est. Completion 2028-07
Phase Phase 3
Avidity Biosciences

8 total trials

What NCT07038200 shows while recruiting

NCT07038200 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,479-participant average among 6 other Facioscapulohumeral Muscular Dystrophy trials with a reported enrollment target (86% lower).

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

NCT07038200 names 20 study sites across 17 states, led by California, Alberta, Other.

Frequently Asked Questions

What is clinical trial NCT07038200 about?

NCT07038200 is a clinical study titled "A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD". A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

What is the current status of trial NCT07038200?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-06-10. Estimated completion is 2028-07.

What conditions does trial NCT07038200 study?

This clinical trial studies the following conditions: Facioscapulohumeral Muscular Dystrophy, FSHD, Fascioscapulohumeral Muscular Dystrophy, FSHD - Facioscapulohumeral Muscular Dystrophy, FSHD1.

What interventions are being tested in trial NCT07038200?

The interventions under investigation include: Placebo (DRUG), AOC-1020 (DRUG).

Who is sponsoring clinical trial NCT07038200?

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

Where is trial NCT07038200 being conducted?

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

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More recruiting context for NCT07038200

Source: ClinicalTrials.gov NCT07038200, the US trial registry maintained by the National Library of Medicine. NCT07038200 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.