Status:
ENROLLING_BY_INVITATION
Phase 2 Open-label Extension Study of AOC 1020 in Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)
Lead Sponsor:
Avidity Biosciences, Inc.
Conditions:
FSHD
FSHD1
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
Brief Summary
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 (FS...
Detailed Description
This study will continue to evaluate the safety, tolerability, and efficacy of AOC 1020 in participants who were treated in the randomized, placebo-controlled, Phase 1/2 AOC 1020-CS1 clinical study. ...
Eligibility Criteria
Inclusion
- 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. When enrolling participants who are minors, it is necessary to also obtain consent from a legally designated representative and the participant will receive information in a way adapted to their age and mental maturity.
- Completion of AOC 1020-CS1 with the following as judged by the Investigator and Sponsor:
- No significant tolerability issues
- Satisfactory compliance with the AOC 1020-CS1 protocol requirements
Exclusion
- Pregnancy, intent to become pregnant during the clinical study, or active breastfeeding.
- Unwilling or unable to continue to comply with contraceptive requirements for the length of AOC 1020-CS2.
- Any new conditions or worsening of existing condition(s) that in the opinion of the Investigator or Sponsor would make the participant unsuitable for the study or could interfere with participation or completion of the study. (Note: FSHD progression is not exclusionary, even if the participant no longer has the ability to walk 10 meters without a walker or two canes.)
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06547216
Start Date
July 25 2024
End Date
April 1 2028
Last Update
December 20 2024
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
Stanford University
Palo Alto, California, United States, 94304
3
University of California San Diego
San Diego, California, United States, 92093
4
University of Colorado
Denver, Colorado, United States, 80045