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

Launched by AVIDITY BIOSCIENCES, INC. · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Del-brax (also known as AOC 1020) for people with facioscapulohumeral muscular dystrophy (FSHD), a condition that causes muscle weakness, especially in the face, shoulders, and arms. The goal of the study is to see if this medicine, given through an IV (a needle in the vein), is safe and helps improve muscle strength and function in people with FSHD.

To take part, participants need to have a confirmed diagnosis of FSHD type 1 or 2 and be able to walk on their own for at least 10 meters, even if they use braces or supports. The study is looking for adults of any gender who meet these criteria and don’t have certain health issues like high blood pressure or recent use of other experimental treatments. If accepted, participants will receive either the study drug or a placebo (a treatment with no active medicine) without knowing which one, to fairly test how well Del-brax works. The trial is currently recruiting people who want to help researchers find better options for managing FSHD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • Treatment with another investigational drug or biological agent within 1 month of Screening or 5 half-lives of the drug, whichever is longer
• • Treatment with an oligonucleotide within 9 months of Screening