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The ENTR-601-DMD-202 study (also called ELEVATE-LTE) is a global, open-label*, Phase 2 study evaluating the long-term safety, tolerability and effectiveness of:
*All participants will receive the same dose of investigational study drug they were receiving upon completion of the parent study with no chance of receiving placebo.
ELEVATE-LTE is an open-label study enrolling participants from ELEVATE-44 and ELEVATE-45 studies.
ELEVATE-LTE study is designed to:
Evaluate the long-term safety of ENTR-601-44 and ENTR-601-45 (also called the study drugs)
Study the body's immune response to the study drugs over an extended time period
Evaluate how effective they are long-term, by measuring dystrophin production and comparing results recorded from the parent studies
Only participants who completed the ELEVATE-44 or ELEVATE-45 study are eligible for the ELEVATE-LTE study.
The study will be taking place in the same locations as the parent studies (United Kingdom, Belgium, Italy, Netherlands and Spain)
Reasonable study-related expenses, such as travel, accommodation and meals will be covered for study participants in accordance with local regulations. This includes booking assistance for travel and lodging. The study doctor can provide more information on additional covered expenses.
*For a full listing of sites please visit the Clinical Trials Registry.
There will be approximately 40 participants enrolled from each of the parent studies (approximately 80 total). Study-related care will be provided by a study doctor with deep experience in Duchenne.
All participants will receive the study drug at the same dose as they did during their parent study with no chance of receiving a placebo. An increase in dose may be possible depending on safety and effectiveness data that may emerge throughout the duration of the LTE study, or if it is determined by study personnel that a patient's current dosing is either ineffective or unsafe.
Over the span of approximately two years, the study doctor will administer the study drug via intravenous (IV) infusion approximately once every six weeks. Additional visits will occur throughout the study to learn more about the safety and potential impact of the study drugs on the body's functions. These visits may be done at the study site or at the participant's home by a qualified home healthcare professional, in accordance with local regulations.
Participants will have a muscle biopsy at the beginning of their participation and after their last dose. Muscle biopsies are important because they allow researchers to compare whether there have been changes in the muscle as a result of the study drug.
Clinical studies come with risks. It is important to make an informed decision before deciding to join a study. Making an informed decision means asking questions until those considering participation know what to expect.
If you or a loved one are interested in participating in a clinical study, consult your doctor to determine eligibility and collect the information needed to make an informed decision.
Entrada believes that study participation should not be a financial burden. For the inconvenience related to participation, participants may be compensated for the study visits completed, according to their country’s local regulations. In addition, reasonable study-related expenses, such as travel, accommodation and meals will be covered for study participants in accordance with local regulations. This includes booking assistance for travel and lodging. The study doctor can provide more information on additional covered expenses.
No additional payments or compensation will be provided for participating in the study.
Yes, all participants will receive the study drug at the same dose as they did during their parent study with no chance of receiving a placebo.
Yes. Being in the study is completely voluntary and participants can stop at any time.
Yes, it is important for participants to maintain regular visits with their primary doctor and care team to ensure that existing care plans remain on track.
For the most part, yes. However, this will depend on the type of medicine the participant is currently taking. Some medicines are not allowed during the study for safety reasons. The study doctor will inform potential participants if any changes to current medicines are necessary.
Entrada adapted the below information from materials developed by Center for Information and Study on Clinical Research Participation, an independent non-profit organization dedicated to engaging the public and patients as partners in the clinical research process.
Clinical studies are the best way to evaluate a study drug and learn if it works and how safe it is. If you have ever taken medicine or gotten a vaccine, then you have benefited from clinical studies.
Studies try to answer specific health questions, like if the study drug has any effects on the disease, if it could work better than an existing treatment and if it’s safe for people to use. A “study drug” means that it has not been approved by a government agency for use outside of clinical studies. If clinical studies show that the study drug works and is safe, then it can be submitted for approval to government agencies. If approved, the study drug can then become available to the people who need it.
People participate in clinical studies for a variety of reasons. Some participate to help others and to increase the understanding of a condition or the science behind a study drug. Those with a disease might participate to receive access to a study drug before it is approved and accessible to the general public.
Clinical studies come with risks. Comparing the potential risks and benefits is an important part of deciding whether to participate. If you or a loved one are interested in participating in a clinical study, consult your doctor to determine eligibility and collect the information needed to make an informed decision.
Information on active studies can be found by searching the clinical study databases below.
Patient advocacy organizations, such as the World Duchenne Organization, also maintain a list of ongoing Duchenne studies.
Each study needs participants who meet certain requirements, like having a certain disease or medical condition. These requirements are called inclusion criteria. Other inclusion criteria could be characteristics like age, sex and current medicine(s) that the participant may be taking.
Clinical studies have specific requirements to ensure safety. These requirements might exclude participation by people whose conditions could worsen with the study drug. This helps protect participants from potential harm. These requirements are called exclusion criteria.
Inclusion and exclusion criteria are in place to make sure the researchers get the most accurate results and make studies as safe as possible for participants.
Personal data may be collected and processed through inquiries. To learn more about how your personal data is processed, please see Entrada's Privacy Policy located at Entrada Therapeutics | Privacy Policy
ENTR-601-44 and ENTR-601-45 are study drugs, which have not been approved for use outside of clinical studies in any country.
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