Actively Recruiting
A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
Led by Avidity Biosciences, Inc. · Updated on 2026-01-20
200
Participants Needed
22
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and genetic diagnosis of FSHD1 or FSHD2
- Ability to walk independently at pre-specified walking speed for at least 10 meters (orthoses and ankle braces allowed) at screening
- Adequate muscle strength based on Quantitative Muscle Testing composite score
You will not qualify if you...
- Breastfeeding, pregnancy, or intent to become pregnant during the study
- Unwilling or unable to comply with contraceptive requirements
- Abnormal lab values, conditions, or diseases making participation unsuitable
- Blood pressure greater than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
University of Colorado
Denver, Colorado, United States, 80045
Actively Recruiting
4
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
5
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Kansas University Medical Center
Kansas City, Kansas, United States, 66205
Actively Recruiting
7
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
8
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Actively Recruiting
9
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
10
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
11
Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
12
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
14
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
15
University of Calgary - Cumming School of Medicine
Calgary, Alberta, Canada
Actively Recruiting
16
University of Alberta Hospital
Edmonton, Alberta, Canada
Not Yet Recruiting
17
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
18
Genge Partners Inc
Montreal, Quebec, Canada
Not Yet Recruiting
19
National Hospital Organization Osaka Toneyama Medical Center
Osaka, Japan
Actively Recruiting
20
The University of Osaka Hospital
Osaka, Japan
Actively Recruiting
21
National Hospital Organization Sendai Nishitaga Hospital
Sendai, Japan
Actively Recruiting
22
National Center of Neurology and Psychiatry
Tokyo, Japan
Actively Recruiting
Research Team
A
Avidity Biosciences, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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