Are you suffering from Moderate to Severe Asthma?
We are looking for people with moderate to severe Asthma for a new clinical research study.
About Moderate to Severe Asthma
Moderate -to -Severe Asthma is a common inflammatory disease that affects the airways and lungs. Inflammation and constriction of the airways of the lung , can result in limitation of daily activities, decreased quality of life, emergency room visits, inpatient admission, and even death.
Asthma can cause difficulty breathing, wheezing, coughing and difficulty sleeping.
Asthma is a chronic condition and affects up to 262 million people worldwide. Multiple treatment options are available that can ease symptoms.
What is the AIRCULES study?
Researchers at select research centers are looking for people between 18 to 80 years old, who carry a diagnosis of moderate-to-severe asthma for at least the past 12 months. The goal of the AIRCULES study is to learn more about the investigational study drug, Lunsekimig, and whether it may improve the symptoms of people suffering with moderate-to-severe Asthma, as well as its associated safety and tolerability. The investigational study drug, Lunsekimig, is given as an injection under the skin (also called subcutaneously) and is investigational, meaning that it hasn’t been fully tested and is not approved by any health authority yet, except for use in clinical research studies like this one. The investigational study drug is not approved by health authorities such as the US Food and Drug Administration (FDA) and is still under investigation for the treatment of asthma, so its effectiveness and safety have not been established.
The study is a randomized study, meaning that participants are randomly assigned (like flipping a coin) to one of two groups. One group is given the investigational study drug Lunsekimig and the other group is given a placebo. A placebo looks like investigational study drug, but contains no active ingredients. The study is double-blind so neither participants nor study doctors will know which group you are placed in. Both groups are followed equally by the study doctor and research centers’ staff.
This is a Phase 2 clinical research study in which you will receive subcutaneous injections of the investigational study drug or a placebo at specific time points. After an initial period of screening of up to 4 weeks, you will receive either the investigational study drug Lunsekimig or placebo and usual care for up to 48 weeks. There will be approximately 8 weeks of follow-up after the last dose of the investigational study drug or placebo. Qualified participants will receive the investigational study drug or placebo, lab tests and study-related medical care at no cost. If you choose to take part in the study you may receive compensation for your time and travel costs for study visits.
Who can take part in the AIRCULES study?
To pre-qualify for this study, you must*:
*Please note that other criteria will apply
What would taking part in the study involve?
The total study duration will last approximately 56 weeks. The study includes the following:
Screening Period (up to 4 weeks)
Study Treatment Period (48 weeks)
If you are eligible for the study, you will enter the Study Treatment Period which lasts for 48 weeks and requires 14 visits to the study site. Participants have a seven out of nine chance (78% chance) of getting the investigational study drug (Lunsekimig) instead of the placebo.
During the study treatment period you will visit the study site repeatedly to receive an injection under the skin to abdomen, thigh, or upper arm of the investigational study drug (Lunsekimig) or a placebo. During your visits to the study site, you will also have other tests performed such as blood and urine tests as well as breathing studies, and the study doctor and study team will monitor you closely.
On a daily basis throughout the study, you will use an eDiary to record daily how your symptoms are and perform brief at-home breathing tests.
Follow Up Period (4 weeks)
There will be a follow-up period of 4 weeks after the Study Treatment Period is complete. During the follow-up period, you will have some procedures like blood, urine tests and vital sign checks.
How do I take part in the study?
Complete
the online questions to see if the study is a good match for you
Answer
our call to answer more questions and learn about the study
Confirm
your interest and research center location
Speak
with the research center about the next steps to take part
Frequently Asked Questions
Where can I find more information about this study?
You can learn more about this study by visiting https://clinicaltrials.gov/study/NCT06102005?cond=NCT06102005&rank=1
What is a clinical research study?
Clinical studies explore whether an investigational study drug, treatment, or device is safe and effective for humans.
Clinical studies are scientific studies in which investigational study drugs and treatments are tested to find out if they are safe and effective for people to take and use. They are one of the most important steps in bringing new potential treatments to patients.
Why is clinical research important?
Clinical research adds to medical knowledge and helps bring new potential treatments to people with medical conditions. To bring new treatments to the public, they need be assessed in clinical studies, to determine if they work and are safe.
Clinical studies rely on the participation of volunteers. It can take several years for a new potential treatment to reach the public. Often, this timeline is due to how long it takes to complete the clinical study, which can be due to shortage of participants.
All approved prescription drugs have gone through clinical studies to make sure that they are effective and to understand what side effects may be involved.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centers, voluntary groups, or health care providers. The AIRCULES study are funded by Sanofi US Services, Inc., a pharmaceutical company.
Every clinical study center is led by a principal investigator, who is a medical doctor or another health care professional. Clinical studies also have a research team that may include doctors, nurses, and other health care professionals.
What are the phases of clinical research studies?
Clinical studies are conducted in different phases.
Phase 1: After researchers have investigated the potential investigational drug in laboratory tests or in animals to see if it has an effect and ensure that it is safe to test in humans, the Phase 1 study is carried out to test the potential investigational drug in a small group of people for the first time. This is done to evaluate its safety, determine a safe dosage range, and identify potential side effects. The potential investigational study drug is referred to as a study drug since it is under investigation and not yet approved for use.
Phase 2: The investigational study drug is given to a larger group of people (compared to Phase 1) to see if it is effective and to further evaluate its safety.
Phase 3: The investigational study drug is given to large groups of people to confirm its efficacy, monitor side effects, compare it to commonly used treatments or placebo, and collect information that will allow the investigational study drug to be used safely.
What is a “placebo”?
“Placebo” is a term used to describe something that looks like the investigational study drug but does not contain any active ingredients.