ELEVATE-LTE: ENTR-601-44 & ENTR-601-45 Long-Term Duchenne Clinical Trial
Study Overview
- Age
- 4–20 years
- Phase
- Phase 2
- Sponsor
- Entrada Therapeutics
- Therapeutic Approach
- Exon Skipping
- Variant Requirement
- Participant completed clinical study ENTR-601-44-201 or ENTR-601-45-201.
- Eligible Sex
- Male
- Ambulation
- Ambulatory
- Study Start (Actual)
- 2026-08
- Primary Completion (Estimated)
- 2032-03
- Study Completion (Estimated)
- 2032-03
- Enrollment (Estimated)
- 80
- Countries
- BelgiumItalyNetherlandsSpainUnited Kingdom
Study Requirements and Criteria
Steroid Use
Not yet provided
Inclusion Criteria
- Willing and able to provide consent (if at age of majority) or assent (if a minor)
- Males who are sexually active with a female partner of childbearing potential must agree to use condoms during sexual intercourse
Exclusion Criteria
- Any change from the applicable parent study eligibility criteria, including safety events during the parent study, that in the opinion of the investigator in consultation with the medical monitor and/or sponsor designee precludes safe use of study drug
- Participant has a condition or circumstance that in the view of the investigator places the subject at high risk of poor treatment compliance or for not completing the study
Contacts and Locations
Contacts and Locations
Contact
Not yet provided
Locations
This study has 17 locations
Belgium
Ghent, Belgium, 9000
University Hospital Gent
Leuven, Belgium, 3000
UZ Leuven
Liège, Belgium, 4000
Centre Hospitalier Régional de la Citadelle
Italy
Milan, Italy, 20132
IRCCS Ospedale San Raffaele
Milan, Italy, 20162
Fondazione Serena Onlus - Centro Clinico NeMO Milano
Roma, Italy, 00168
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Italy, 00165
Ospedale Pediatrico Bambino Gesu
Netherlands
Leiden, Netherlands, 2333 ZA
Leids Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Stichting Radboud Universitair Medisch Centrum
Spain
Barcelona, Spain, 08035
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08950
Hospital Sant Joan de Deu
United Kingdom
Leeds, United Kingdom, LS1 3EX
Leeds General Infirmary
Liverpool, United Kingdom, L122AP
Alder Hey Children's NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Great Ormond Street Hospital for Children
Manchester, United Kingdom, M13 9WL
Royal Manchester Children's Hospital
Newcastle upon Tyne, United Kingdom, NE1 3BZ
Freeman Hospital
Oxford, United Kingdom, OX3 9DU
Oxford University Hospitals NHS Foundation Trust
Clinical Trial Registry
NCT ID
NCT07682129This information is provided for educational purposes only. Always consult the study investigators before making medical decisions.