Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07037862 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44

Study acronym: ELEVATE-44
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 14 sitesv7
  2. Site details revised at 1 of 14 sitesv6
  3. Study sites: 15 to 14v5
  4. Primary endpoint revised Study sites: 14 to 15 · Secondary endpoints revised (11) · Eligibility criteria expanded, about 3 wordsv4 Show 3 more changesShow less
    • Study sites: 14 to 15
    • Secondary endpoints revised (11)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoint revised Eligibility criteria shortened, about 47 words · Secondary endpoints: 5 to 11 · Site details revised at 5 of 14 sitesv3 Show 3 more changesShow less
    • Eligibility criteria shortened, about 47 words
    • Secondary endpoints: 5 to 11
    • Site details revised at 5 of 14 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Site details revised at 14 of 14 sitesv2 Show 1 more changeShow less
    • Site details revised at 14 of 14 sites
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a study of the investigational medicine ENTR-601-44 in participants who have Duchenne muscular dystrophy (DMD), a rare genetic condition. The researchers want to: Test how safe ENTR-601-44 is, learn about any side effects, and look at the potential positive effects of ENTR-601-44, compared to placebo. Placebo looks like the investigational medicine but does not contain any active ingredient. In this summary ENTR-601-44 and placebo are both called study treatments. The study has 2 parts: * Part A * A Double-Blind Period, to evaluate if ENTR-601-44 is safe and to determine the best dose of ENTR-601-44 for Part B. * Following the Double-Blind period, participants will roll into an open-label treatment period during which the safety and efficacy of extended dosing will be evaluated. * Part B * To further evaluate the effect and safety of ENTR-601-44 at the dose determined in Part A. Participants will: * Receive study treatment in the form of multiple intravenous (IV) infusions (slow injection) into a vein over the course of several weeks in Part A and in Part B * Visit the clinic regularly for checkups and tests such as: blood and urine tests, physical examinations, questionnaires, and exercise 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 result 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.
Trial Details
NCT Number NCT07037862
Lead Sponsor Entrada Therapeutics, Inc.
Conditions Duchenne Muscular Dystrophy (DMD)
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov