Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05881408 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)

Study acronym: ENVISION
StatusActive, Not Recruiting
PhasePhase 3
Started2023-05-31
View on ClinicalTrials.gov ↗

Amendment history

2026-05-21
Study Status v21
Re-verified, no change to tracked fields
2025-06-18
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v20
Trial statusRecruiting→Active, Not Recruiting
Study sites47→46
2025-05-30
Study Status, Contacts/Locations v19
Study sites43→47
2025-04-11
Study Status, Contacts/Locations v18
Study sites42→43
2025-02-14
Study Status, Contacts/Locations v17
Study sites39→42
Show 16 earlier versions
2025-01-17
Study Status, Outcome Measures, Eligibility v16
Eligibility criteria+24 characters
[...] genetic testing. Cohort 1 only: Non-ambulatory per protocol-specified criteria. Cohort 2 only: Ambulatory per protocol-specified criteria and ≥8 to <18 years of age at the time of [...] s. A pathogenic frameshift mutation or premature stop codon containedin betweenthe exonsDMD 18gene, except for any deletion mutations in exon 8 and/or 79 (inclusive)9. Exclusion Criteria: Exposure to gene therapy, investigatio [...]
Secondary endpoints7 to 8 entries
Part 1: Change From Baseline in the Middle Domain Score of PUL (Version 2.0) at Week 72
2024-12-19
Study Status, Contacts/Locations v15
Study sites38→39
2024-11-21
Study Status, Contacts/Locations v14
Study sites37→38
2024-10-22
Study Identification, Study Status, Conditions, Contacts/Locations v13
Study sites33→37
2024-09-16
Study Status, Contacts/Locations v12
Primary completion date2026-01-31→2027-05-31
Completion date2027-01-31→2028-06-30
Study sites28→33
2024-07-23
Study Status, Contacts/Locations v11
Study sites26→28
2024-05-09
Study Status, Contacts/Locations v10
Study sites22→26
2024-03-22
Study Status, Contacts/Locations v9
Study sites20→22
2024-02-27
Study Status, Contacts/Locations v8
Study sites15→20
2023-12-20
Study Status, Contacts/Locations v7
Study sites14→15
2023-11-21
Study Status, Contacts/Locations, References v6
Study sites12→14
2023-10-06
Study Status, Contacts/Locations v5
Study sites7→12
2023-09-06
Study Status, Contacts/Locations v4
Study sites4→7
2023-07-28
Study Status, Outcome Measures, Contacts/Locations v3
Study sites2→4
Secondary endpoints7 entries, revised
Part 1: Quantity of Delandistrogene Moxeparvovec Micro-Dystrophin Protein Expression at Week 12 as Measured by Western Blot
2023-06-30
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06-30→confirmed 2023-05-31
Study sites1→2
InterventionsPlacebo (Genetic), SRP-9001 (Genetic)→delandistrogene moxeparvovec (Genetic), placebo (Genetic)
Secondary endpoints7 entries, revised
Part 1: Quantity of SRPDelandistrogene Moxeparvovec Micro-9001Dystrophin Protein Expression at Week 12 as Measured by Western Blot
Study titlerevised
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001 (Delandistrogene Moxeparvovec) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
2023-06-07
Study Status, Contacts/Locations v1
Study sites14→1
2023-05-19
Original filing
The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study. Participants will be in the study for approximately 128 weeks. All participants will have the opportunity to receive intravenous (IV) delandistrogene moxeparvovec in either Part 1 or Part 2.
Trial Details
NCT Number NCT05881408
Lead Sponsor Sarepta Therapeutics, Inc.
Collaborators: Hoffmann-La Roche
Conditions Duchenne Muscular Dystrophy
Enrollment 148 participants
Start Date 2023-05-31
Primary Completion 2027-05-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-22