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New treatment option for Facioscapulohumeral Muscular Dystrophy
Official title A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
ClinicalTrials.gov ID: NCT07038200
What this study is testing
What is AOC-1020?
AOC-1020 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for facioscapulohumeral muscular dystrophy.
Also referred to as del-brax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 70
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Palo Alto, California, United States
- Denver, Colorado, United States
- Gainesville, Florida, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Worcester, Massachusetts, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- San Antonio, Texas, United States
- Richmond, Virginia, United States
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
- Aarhus, Denmark
- Copenhagen, Denmark
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Palo Alto, California, United States; Denver, Colorado, United States; Gainesville, Florida, United States; Iowa City, Iowa, United States; Kansas City, Kansas, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.