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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: ENTR-601-44 (drug), ENTR-601-44 - matching placebo (drug)
How long the study runs: Study runs about 45 months (dates as stated)
About the drug or intervention: ENTR-601-44 — drug: intravenous infusion · ENTR-601-44 - matching placebo — drug: intravenous infusion
Patient visit burden: Not specified by the sponsor

In plain English

This study is looking at a potential treatment called ENTR-601-44 for people with Duchenne muscular dystrophy (DMD) whose particular genetic change may respond to an approach called 'exon 44 skipping'. The study will test how safe the treatment is and how well it works. It is funded by Entrada Therapeutics, Inc.

Who can take part

A genetic diagnosis of Duchenne muscular dystrophy with a change in the dystrophin gene that may respond to exon 44 skipping, checked by a genetic counsellor.
Assigned male at birth, with signs of Duchenne muscular dystrophy as judged by the study doctor.
For Part A of the study: aged 4 to 20 years.
For Part A: able to walk, with arm function measured using a test called the Performance of the Upper Limb version 2.0 (PUL 2.0).
Enough healthy muscle for a small tissue sample (biopsy) to be taken, as judged by the study doctor.
Other rules in the study plan also apply.

Who may not be able to

Another serious medical condition that could make taking part in the study difficult.
A sudden illness within 4 weeks before the first dose that could affect study measurements or safety.
Previous treatment with any exon skipping therapy or gene therapy at any time.
Taking blood-thinning medicines (anti-coagulants, anti-thrombotics or anti-platelet drugs).
Taking immunosuppressant medicines (except corticosteroid tablets for DMD).
Taking a type of medicine called a histone deacetylase (HDAC) inhibitor, such as givinostat.
Blood test results outside the ranges set by the study.
Needing a ventilator during the day, or invasive ventilation through a hole in the neck (tracheostomy).
An abnormal heart tracing (electrocardiogram, ECG) judged important by the study doctor, or a heart rhythm measure (QTcF) longer than 450 milliseconds.
Taking any experimental or investigational medicine within 3 months before the first dose, or within 5 half-lives of that medicine (whichever is longer).
Other rules in the study plan also apply.

What taking part involves

• Receiving the study medicine ENTR-601-44 — not stated how it is given; ask the trial team.
• Muscle tissue samples (biopsies) will be taken as part of the study.
• Arm function will be measured using the Performance of the Upper Limb version 2.0 (PUL 2.0) test.
• Heart checks using an electrocardiogram (ECG) and blood tests are part of the study.

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 4 Years to 20 Years
Who: Male
Number of participants: 24
Started: 2025-06-30
Last checked: 2026-03

Plain English Summary

What is this study?

• Testing a new treatment for duchenne muscular dystrophy (dmd)
• Phase1/Phase2 - 24 participants
• This is a study of the investigational medicine ENTR-601-44 in participants who have Duchenne muscular dystrophy (DMD), a rare genetic condition

Who can take part?

• Ages 4 Years to 20 Years
• Diagnosed with duchenne muscular dystrophy (dmd)
• Male only

Where?

• Leeds - Leeds General Infirmary
• Liverpool - Alder Hey Children's NHS Foundation Trust
• London - Great Ormond Street Hospital for Children
• Manchester - Royal Manchester Children's Hospital
• +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Duchenne Muscular Dystrophy (DMD)

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 4 Years - 20 Years
Who can join: Male only

Treatment history

Treatments you must have had:

✓ any exon skipping therapy at any time
✓ any gene therapy at any time

What the study is looking for

✓Principal inclusion criteria
✓Genetic diagnosis of Duchenne muscular dystrophy (DMD) and confirmed disease variant in the dystrophin gene...
✓Assigned male at birth with clinical signs compatible with Duchenne muscular dystrophy as determined by the...
✓Part A: 4-20 years of age, inclusive.
✓Ambulatory Status Part A: ambulatory with a Performance of the Upper Limb v2.0 (PUL 2.0) Entry as per protocol at...

See the full criteria

Principal inclusion criteria 1. Genetic diagnosis of Duchenne muscular dystrophy (DMD) and confirmed pathologic variant in the dystrophin gene amenable to exon 44 skipping as reviewed by a central genetic counselor. 2. Assigned male at birth with clinical signs compatible with Duchenne muscular dystrophy as determined by the investigator. 3. Part A: 4-20 years of age, inclusive. 4. Ambulatory Status Part A: ambulatory with a Performance of the Upper Limb v2.0 (PUL 2.0) Entry as per protocol at Screening 5. Adequate muscle for obtaining tissue biopsy as assessed by the investigator. 6. Other protocol-defined criteria apply. Principal exclusion criteria 1. Any significant concomitant medical condition that might interfere with the ability to comply with protocol requirements. 2. Has an acute illness within 4 weeks prior to the first dose of study drug which may interfere with study measurements or jeopardize participant's safety. 3. Use of the following medications: 1. Prior treatment with any exon skipping therapy at any time 2. Prior treatment with any gene therapy at any time 3. Use of anti-coagulants, anti-thrombotics, or anti-platelet agents 4. Use of an immunosuppressants (other than oral corticosteroids for DMD conditions) 5. Has taken or is currently taking a histone deacetylase (HDAC) inhibitor, including (but not limited to) givinostat 4. Laboratory abnormalities. 5. Daytime ventilator dependence or any use of invasive mechanical ventilation via tracheostomy. 6. Has an abnormal electrocardiogram (ECG) reading assessed as clinically significant by the investigator, and/or a QT interval with Fridericia correction method (QTcF) \>450 msec at Screening or prior to the first dose of study drug on Day 1. 7. Received any experimental or investigational drug, etc. within 3 months prior to first dose or within 5 half-lives (whichever is longer). 8. Other protocol-defined criteria apply.