AOC 1020 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

Be older than 18 years old

Must not have

Unwilling or unable to comply with contraceptive requirements for the length of AOC 1020-CS2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial will study the long-term effects of AOC 1020 given through an IV to adults 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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot or will not follow the birth control rules during the AOC 1020-CS2 study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met