Ph2 Open-label Study of AOC 1044 in Duchenne Muscular Dystrophy Participants With Mutations Amenable to Exon44 Skipping (EXPLORE44OLE)
A Phase 2 Open-label Study to Evaluate the Pharmacodynamics and Long-Term Safety and Tolerability of AOC 1044 Administered Intravenously to DMD Participants With Mutations Amenable to Exon 44 Skipping
Sponsor: Avidity Biosciences, Inc.
Listed as NCT06244082, this PHASE2 trial focuses on DMD and Duchenne and remains ongoing. Sponsored by Avidity Biosciences, Inc., it has been updated 8 times since 2024, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)AOC 1044-CS2 (EXPLORE44-OLE) is an open label, extension study to Part B of AOC 1044-CS1 (EXPLORE44). AOC 1044-CS2 is designed to evaluate the long-term safety, tolerability, pharmacokinetics, and exploratory efficacy of AOC 1044.
All participants who enroll in AOC 1044-CS2 will receive active treatment. The treatment period is 2 years with IV dosing every 6 weeks.
Once participants have completed active treatment, they will be followed through a 3-month safety follow-up period. The sponsor may extend active treatment beyond 2 years at a future timepoint.
AOC 1044-CS2 (EXPLORE44-OLE) is an open label, extension study to Part B of AOC 1044-CS1 (EXPLORE44). AOC 1044-CS2 is designed to evaluate the long-term safety, tolerability, pharmacokinetics, and exploratory efficacy of AOC 1044.
All participants who enroll in AOC 1044-CS2 will receive active treatment. The treatment period is 2 years with IV dosing every 6 weeks.
Once participants have completed active treatment, they will be followed through a 3-month safety follow-up period. The sponsor may extend active treatment beyond 2 years at a future timepoint.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Active Not Recruiting PHASE2
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Sep 2025 — Present [monthly]
Active Not Recruiting PHASE2
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Jun 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE2
-
Mar 2025 — Jun 2025 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Oct 2024 — Mar 2025 [monthly]
Recruiting PHASE2
Status: Enrolling By Invitation → Recruiting
▶ Show 3 earlier versions
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Sep 2024 — Oct 2024 [monthly]
Enrolling By Invitation PHASE2
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Jul 2024 — Sep 2024 [monthly]
Enrolling By Invitation PHASE2
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Mar 2024 — Jul 2024 [monthly]
Enrolling By Invitation PHASE2
First recorded
Jan 2024
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Avidity Biosciences, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .