A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
NCT ID: NCT07038200
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-06-10
2028-07-31
Brief Summary
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Detailed Description
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Participants will be randomized to receive an intravenous infusion of either del-brax or placebo at the clinical study site every 6 weeks for a total of 13 doses. The final dose will occur at Week 72, followed by a final assessment at Week 78.
After completion of the Week 78 visit, eligible participants will have the option to enroll into an open label extension (OLE) study, pending regulatory approval. Participants who decline participation in the OLE will be followed for a period of 12 weeks for safety.
An Independent Data Monitoring Committee (IDMC) comprising members independent and external to the Sponsor will review safety, tolerability, and efficacy (as needed) data of this study at regular intervals.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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del-brax
Del-brax (AOC 1020) will be administered 13 times
AOC-1020
Placebo
placebo
Saline will be administered 13 times
Placebo
Placebo will be administered by intravenous (IV) infusion.
Interventions
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AOC-1020
Placebo
Placebo
Placebo will be administered by intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
70 Years
ALL
No
Sponsors
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Avidity Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California Irvine
Orange, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Calgary - Cumming School of Medicine
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Genge Partners Inc
Montreal, Quebec, Canada
National Hospital Organization Osaka Toneyama Medical Center
Osaka, , Japan
The University of Osaka Hospital
Osaka, , Japan
National Hospital Organization Sendai Nishitaga Hospital
Sendai, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Countries
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Central Contacts
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Related Links
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Related Info
Related Info
Other Identifiers
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AOC 1020-CS3
Identifier Type: -
Identifier Source: org_study_id
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