Phase 2 Open-label Extension Study of AOC 1020 in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT06547216 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2026-05-14
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 (FSHD)
Conditions
- FSHD
- FSHD1
- FSHD2
- FMD
- FMD2
- Fascioscapulohumeral Muscular Dystrophy
- Fascioscapulohumeral Muscular Dystrophy Type 1
- Fascioscapulohumeral Muscular Dystrophy Type 2
- Dystrophies, Facioscapulohumeral Muscular
- Dystrophy, Facioscapulohumeral Muscular
- Facioscapulohumeral Muscular Dystrophy 1
- Facioscapulohumeral Muscular Dystrophy 2
- Facio-Scapulo-Humeral Dystrophy
- Atrophy, Facioscapulohumeral
- Atrophies, Facioscapulohumeral
- Facioscapulohumeral Atrophy
- Muscular Dystrophies
- Muscular Dystrophy, Facioscapulohumeral
- FSH Muscular Dystrophy
- Landouzy Dejerine Dystrophy
- Landouzy-Dejerine Muscular Dystrophy
- Dystrophies, Landouzy-Dejerine
- Dystrophy, Landouzy-Dejerine
- Landouzy-Dejerine Syndrome
- Muscular Dystrophy, Landouzy Dejerine
- Progressive Muscular Dystrophy
- FSH
Interventions
- DRUG
-
AOC 1020
AOC 1020 will be administered via intravenous (IV) infusion
Sponsors & Collaborators
-
Avidity Biosciences, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 72 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-25
- Primary Completion
- 2030-04-30
- Completion
- 2030-06-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- United Kingdom
Study Locations
More Related Trials
-
Study of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT02927080 ·Status: TERMINATED ·Phase: PHASE2
-
Intramuscular Transplantation of Muscle Derived Stem Cell and Adipose Derived Mesenchymal Stem Cells in Patients With Facioscapulohumeral Dystrophy (FSHD)
NCT02208713 ·Status: UNKNOWN ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATYR1940 in Adult Participants With Muscular Dystrophy
NCT02239224 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD
NCT03458832 ·Status: ACTIVE_NOT_RECRUITING
-
Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT07086521 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects With Genetic Confirmation of LGMD2I/R9 (Part1)
NCT05230459 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease
NCT00004771 ·Status: COMPLETED ·Phase: PHASE2
-
Ph2 Open-label Study of AOC 1044 in Duchenne Muscular Dystrophy Participants With Mutations Amenable to Exon44 Skipping
NCT06244082 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Dose Finding Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)
NCT02740972 ·Status: COMPLETED ·Phase: PHASE2
-
Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie Tooth (CMT) Disease Types 1 and X (CMT1 and CMTX)
NCT03943290 ·Status: TERMINATED ·Phase: PHASE2
-
A Multicenter Collaborative Study on the Clinical Features, Expression Profiling, and Quality of Life of Infantile Onset FSHD
NCT01437345 ·Status: COMPLETED
-
Study of Fordadistrogene Movaparvovec in Early Stage Duchenne Muscular Dystrophy
NCT05429372 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of ATL1102 or Placebo in Participants With Non-ambulatory Duchenne Muscular Dystrophy
NCT05938023 ·Status: TERMINATED ·Phase: PHASE2
-
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
NCT05335876 ·Status: RECRUITING ·Phase: PHASE3
-
Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD
NCT02515669 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Proof of Concept Study to Assess Activity and Safety of SMT C1100 (Ezutromid) in Boys With Duchenne Muscular Dystrophy (DMD)
NCT02858362 ·Status: TERMINATED ·Phase: PHASE2
-
Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)
NCT03167255 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Duchenne Muscular Dystrophy
NCT02310763 ·Status: TERMINATED ·Phase: PHASE2
-
Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy
NCT01826474 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase II Doubleblind Exploratory Study of GSK2402968 in Ambulant Subjects With Duchenne Muscular Dystrophy
NCT01153932 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label Extension Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy
NCT07209332 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Clinical Trial Readiness Network FSHD France: Prospective 24 Months MRI Study
NCT04038138 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Unraveling Metabolic Involvement in Facioscapulohumeral Dystrophy Through Metabolomics
NCT06086548 ·Status: NOT_YET_RECRUITING
-
Phase I/II Study of SRP-4053 in DMD Patients
NCT02310906 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Extension Study of NS-089/NCNP-02 in DMD
NCT05135663 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2