AOC 1020 for Facioscapulohumeral Muscular Dystrophy
(FORTITUDE-OLE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
What makes the drug AOC 1020 unique for treating facioscapulohumeral muscular dystrophy?
AOC 1020 (delpacibart braxlosiran, del-brax) is unique because it represents a novel approach to treating facioscapulohumeral muscular dystrophy, a condition with limited standard treatment options. Its specific mechanism of action, ingredients, or administration route may differ from existing therapies, but detailed information is not provided in the available research.12345
What is the purpose of this trial?
A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of AOC 1020 Administered Intravenously to Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)
Research Team
Amy Halseth, Ph.D.
Principal Investigator
Avidity Biosciences, Inc.
Eligibility Criteria
This trial is for adults with Facioscapulohumeral Muscular Dystrophy (FSHD), a type of muscular dystrophy that affects the muscles of the face, shoulder blades, and upper arms. Participants should have completed prior studies with AOC 1020 or meet specific health criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AOC 1020 intravenously every 6 to 7 weeks for a total of 16 doses over 22 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including monitoring for adverse events, concomitant medications, and pregnancy status
Open-label extension
Continuation of treatment to evaluate long-term safety, tolerability, and efficacy of AOC 1020
Treatment Details
Interventions
- AOC 1020
AOC 1020 is already approved in United States for the following indications:
- Facioscapulohumeral muscular dystrophy (FSHD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Avidity Biosciences, Inc.
Lead Sponsor