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

Part of paid clinical trials in Orange, California.

Sponsor
Avidity Biosciences, Inc.
Study ID
NCT07038200
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • FSH Muscular Dystrophy
  • FSHD
  • FSHD - Facioscapulohumeral Muscular Dystrophy
  • FSHD1
  • FSHD2
  • Facio-Scapulo-Humeral Dystrophy
  • Facioscapulohumeral Dystrophy
  • Facioscapulohumeral Muscular Dystrophy
  • Facioscapulohumeral Muscular Dystrophy 1
  • Facioscapulohumeral Muscular Dystrophy 2
  • Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)
  • Fascioscapulohumeral Muscular Dystrophy
  • Fascioscapulohumeral Muscular Dystrophy Type 1
  • Fascioscapulohumeral Muscular Dystrophy Type 2
  • Landouzy Dejerine Dystrophy
  • Landouzy-Dejerine Muscular Dystrophy
  • Landouzy-Dejerine Syndrome

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • AOC-1020 — DRUG
    Placebo
  • Placebo — DRUG
    Placebo will be administered by intravenous (IV) infusion.

Study Details

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)

Key Dates

Start date
Jun 10, 2025
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: del-brax
    Del-brax (AOC 1020) will be administered 13 times
  • Placebo Comparator: placebo
    Saline will be administered 13 times

Primary Outcome Measure

Quantitative Muscle Testing (QMT) composite score [ Time Frame: Baseline through Week 78 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868-
Stanford UniversityPalo AltoCalifornia94304-
University of ColoradoDenverColorado80045-
University of FloridaGainesvilleFlorida32608-
University of IowaIowa CityIowa52242-
Kansas University Medical CenterKansas CityKansas66205-
Kennedy Krieger InstituteBaltimoreMaryland21205-
University of MassachusettsWorcesterMassachusetts01655-
University of Rochester Medical CenterRochesterNew York14642-
Duke UniversityDurhamNorth Carolina27708-
Ohio State UniversityColumbusOhio43221-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Orange, CA

By research site
University of California Irvine· Orange, CAStanford University· Palo Alto, CAUniversity of Colorado· Denver, COUniversity of Florida· Gainesville, FLUniversity of Iowa· Iowa City, IAKansas University Medical Center· Kansas City, KS

Related Studies