MedTrace Logo

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

NCT07038200 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-20

No results posted yet for this 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)

Conditions

  • Facioscapulohumeral Muscular Dystrophy
  • FSHD
  • FSHD - Facioscapulohumeral Muscular Dystrophy
  • FSHD1
  • FSHD2
  • Fascioscapulohumeral Muscular Dystrophy
  • Fascioscapulohumeral Muscular Dystrophy Type 1
  • Fascioscapulohumeral Muscular Dystrophy Type 2
  • Facioscapulohumeral Muscular Dystrophy 1
  • Facioscapulohumeral Dystrophy
  • Facio-Scapulo-Humeral Dystrophy
  • Facioscapulohumeral Muscular Dystrophy 2
  • Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)
  • FSH Muscular Dystrophy
  • Landouzy Dejerine Dystrophy
  • Landouzy-Dejerine Muscular Dystrophy
  • Landouzy-Dejerine Syndrome

Interventions

DRUG

AOC-1020

Placebo

DRUG

Placebo

Placebo will be administered by intravenous (IV) infusion.

Sponsors & Collaborators

  • Avidity Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2028-05-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07038200 on ClinicalTrials.gov