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ENTR-601-44 · ELEVATE-LTE

Long-Term Extension Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon Skipping to Evaluate the Safety and Efficacy of Endosomal Escape Vehicle Phosphorodiamidate Morpholino Oligomer Platform Products (ELEVATE-LTE)

Ensayo de Entrada Therapeutics, Inc. en Distrofia muscular de Duchenne.

Más ensayos de: Distrofia muscular de Duchenne.

Fase

Fase 2

Estado

Aún sin reclutar

Participantes

80

previstos

Centros

17

Fin del objetivo primario

mar 2032

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2026.

Qué mide

Number of participants with Treatment Emergent Adverse Events (TEAEs) according to study protocol (Part A and OL Period) (From baseline through End of Study (up to 2 years).) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a study of investigational medicines ENTR-601-44 and ENTR-601-45 designed to evaluate the long-term safety and tolerability of study drugs in participants with Duchenne muscular dystrophy (DMD). The investigational medicines are currently being investigated in multiple ascending dose parent studies. After participants complete their respective parent study, there is a need to understand the effects of long-term administration of ENTR-601-44 and ENTR-601-45. Participants enrolling in this study will begin this long-term extension (LTE) study at the dose level they received upon completion of the parent study with possible dose escalation in the LTE study based on emerging safety and efficacy data from the parent studies. Participants will: * Receive study treatment in the form of multiple intravenous (IV) infusions (slow injections) into a vein over the course of several weeks * Visit the clinic regularly for checkups and tests such as: blood and urine tests, physical examinations, questionnaires, and excersice tests. Participants will have a muscle biopsy at the beginning of their participation and after their last dose to allow researchers to compare whether there have been changes in the muscle as a results of the study drug. Participants are allowed to continue receiving their standard of care therapy for DMD during the study, as long as their health remains stable.

Más ensayos de TRDA

Todos los de TRDA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07682129), actualizada en jun 2026.