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

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) - FORTITUDE-3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250486

Enrollment

Registered

2025-11-11

Start date

2025-11-11

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facioscapulohumeral Muscular Dystrophy

Interventions

AOC 1020 2 mg/kg or placebo will be administered by intravenous (IV) infusion every 6 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

Canada, Japan, United Kingdom, United states

Contacts

Public ContactShingo Ito

Medpace Japan K.K.

RSJapan1@medpace.com+81-345637000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026