Recruiting
Phase 3

AOC 1020

Sponsor:

Avidity Biosciences, Inc.

Code:

NCT07038200

Conditions

Facioscapulohumeral Muscular Dystrophy

FSHD

FSHD - Facioscapulohumeral Muscular Dystrophy

FSHD1

FSHD2

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Interventions

AOC-1020

Placebo

Study Details

Brief summary:

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

Facioscapulohumeral Muscular Dystrophy

FSHD

FSHD - Facioscapulohumeral Muscular Dystrophy

FSHD1

FSHD2

Study ID

NCT07038200

Start date

Jun 10, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Del-brax

Del-brax (AOC 1020) will be administered 13 times

placebo comparator: Placebo

Saline will be administered 13 times

Interventions

AOC-1020

Del-brax will be administered by intravenous (IV) infusion.

Placebo

Placebo will be administered by intravenous (IV) infusion.

Primary outcome measure

  • Change from Baseline to Week 78 in Quantitative Muscle Testing (QMT) total composite score (PPN) [ Time Frame: Baseline through Week 78 ]

Central Contacts and Locations

Central contacts

Avidity Biosciences, Inc., A Novartis Company

1-888-669-6682novartis.email@novartis.com

Avidity Biosciences, Inc., A Novartis Company

+41613241111novartis.email@novartis.com

Locations

University of Calgary - Cumming School of Medicine

Recruiting

Calgary, Alberta, Canada

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Genge Partners Inc

Recruiting

Montreal, Quebec, Canada

More Information

Sponsor

Avidity Biosciences, Inc.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Avidity
  • Avidity Biosciences
  • del-brax
  • del brax
  • delbrax
  • AOC1020
  • AOC 1020
  • delpacibart braxlosiran
  • FORTITUDE-3
  • FORTITUDE Phase 3
  • FORTITUDE
  • FORTITUDE 3

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Avidity Biosciences, Inc. on 2026-07-27.