Health Trials

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

ConditionsFacioscapulohumeral Muscular DystrophyFSHDFSHD - Facioscapulohumeral Muscular DystrophyFSHD1FSHD2Fascioscapulohumeral Muscular DystrophyFascioscapulohumeral Muscular Dystrophy Type 1Fascioscapulohumeral Muscular Dystrophy Type 2Facioscapulohumeral Muscular Dystrophy 1Facioscapulohumeral DystrophyFacio-Scapulo-Humeral DystrophyFacioscapulohumeral Muscular Dystrophy 2Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)FSH Muscular DystrophyLandouzy Dejerine DystrophyLandouzy-Dejerine Muscular DystrophyLandouzy-Dejerine Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-70
SponsorAvidity Biosciences, Inc.

About this trial

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)

Eligibility criteria

Qualifiers

Clinical and genetic diagnosis of FSHD1 or FSHD2

Ability to walk independently at pre-specified walking speed (orthoses and ankle braces allowed) for at least 10 meters at screening

Adequate muscle strength based on QMT composite score

Disqualifiers

Breastfeeding, pregnancy, or intent to become pregnant during the study

Unwilling or unable to comply with contraceptive requirements

Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study

Blood Pressure > 140/90 mmHg at Screening

Trial design

Treatments tested in this trial

  • AOC-1020
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

46
Canada
University of Calgary - Cumming School of Medicine CalgaryAlberta, Canada
University of Alberta Hospital EdmontonAlberta, Canada
The Ottawa Hospital OttawaOntario, Canada
Genge Partners Inc MontrealQuebec, Canada

Sponsors and collaborators

Avidity Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov