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AOC 1020 Regimen for Facioscapulohumeral Muscular Dystrophy (FORTITUDE-OLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Avidity Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Ability to provide written informed consent (signed and dated) and any authorizations required by local law and be willing and able to comply with all study requirements.
1. No significant tolerability issues
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to day 729
Awards & highlights

Summary

A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety, Tolerability, Efficacy, and Pharmacokinetics of AOC 1020 Administered Intravenously to Adult Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

Who is the study for?
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.
What is being tested?
The study tests long-term safety and effectiveness of AOC 1020 when given through an IV. It's an open-label extension, meaning everyone knows they're getting AOC 1020 and there's no placebo group.
What are the potential side effects?
Possible side effects are not detailed here but typically include reactions at the infusion site, muscle pain or weakness, fatigue, and potential allergic responses to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to day 729
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to day 729 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: AOC 1020 RegimenExperimental Treatment1 Intervention
AOC 1020 Dose Regimen; Nine doses administered intravenously over 24 months. Treatment assignment will be based on treatment received in AOC 1020-CS1.

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Who is running the clinical trial?

Avidity Biosciences, Inc.Lead Sponsor
7 Previous Clinical Trials
835 Total Patients Enrolled
Amy Halseth, Ph.D.Study DirectorAvidity Biosciences, Inc.
~48 spots leftby Apr 2028
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