NCT07038200 A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD
| NCT ID | NCT07038200 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Avidity Biosciences, Inc. |
| Condition | Facioscapulohumeral Muscular Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2025-06-10 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility 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: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07038200 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 70 Years, studying Facioscapulohumeral Muscular Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07038200 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT07038200 currently recruiting?
Yes, NCT07038200 is actively recruiting participants. Contact the research team at medinfo@aviditybio.com for enrollment information.
Where is the NCT07038200 trial being conducted?
This trial is being conducted at Orange, United States, Palo Alto, United States, Denver, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT07038200 clinical trial?
NCT07038200 is sponsored by Avidity Biosciences, Inc.. The trial plans to enroll 200 participants.