ELEVATE-LTE: ENTR-601-44 & ENTR-601-45 Long-Term Duchenne Clinical Trial
Not Yet RecruitingPhase 2Exon Skipping
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
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
Clinical Trial Registry
NCT ID
NCT07682129This information is provided for educational purposes only. Always consult the study investigators before making medical decisions.