Actively Recruiting

Phase 3
Age: 16Years - 70Years
All Genders
NCT07038200

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

Age: 16Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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