How long is the study?
- Screening period: up to 4 weeks (1 month).
- Treatment period: up to 60 weeks (14 months).
- Follow-up period: up to 12 weeks (3 months).
What is the purpose of the study?
This study is to evaluate how effective and safe the investigational medication, called amlitelimab, is to treat moderate to severe uncontrolled asthma.
What is the investigational medication?
What is a clinical research study?
Clinical research studies are used to show if/how an investigational medication works and to find out if it is safe. They can also be referred to as clinical trials.
Clinical studies are run by qualified healthcare professionals. The doctors and other healthcare providers are responsible for the study-related care of the people that participate (or enroll) in these studies. Clinical trials are a mandatory part of the process that leads to an approval, which is required before a drug can be marketed.
Independent committees (called Institutional Review Boards or IRBs) are made up of medical and non-medical people, who also watch over clinical research studies, to make sure that the people who enroll are properly and adequately informed and consent prior to study participation.
Why are clinical trials conducted?
Clinical trials are essential to the development of new interventions (drugs, vaccines, procedures, devices) that help people to live longer and with less pain or disability.
They help researchers to understand what does and doesn’t work in humans that cannot be learned in the laboratory or in animals. Clinical trials also help doctors decide if the side effects of an investigational treatment are acceptable when weighed against the potential benefits.
How do clinical trials work?
Clinical trials must adhere to Good Clinical Practices (GCP), rigid standards that clearly state what is allowed by medical professionals during a clinical trial.
Clinical trials follow rigid testing procedures designed to help researchers determine the safety and effectiveness of the investigational drug or medical treatment being studied.
What is an investigational medication?
An investigational medication is what is being studied to see if symptoms improve while taking it. The drug is not yet approved for general use by regulatory authorities.
What is a placebo?
A placebo is an inactive substance or treatment that looks the same and is given in the way as the investigational medication/treatment that is being studied.
Why should I join a clinical research study?
Thousands of people volunteer to participate in clinical trials every year. The reasons for participation vary, but all of them help to advance medicine. Some reasons include:
Who can participate in a study?
Every clinical trial has a set of criteria that study participants must meet in order to participate, including agreeing to sign an informed consent form and HIPAA (Health Insurance Portability and Accountability Act) authorization.
What is an informed consent?
What is a double-blind study?
Neither the study participant nor the study doctor will know which treatment the patient is receiving.
What is a Phase II (Phase 2) trial?
Researchers study how the investigational medication is tolerated in patients. Larger groups of patients (up to several hundred people) participate in Phase 2 clinical trials. The purpose of Phase 2 trials is to determine:
In Phase 2 trials, one group of study participant may be given the investigational medication, while the other may be given a placebo or other approved treatment.
What type of study-related medical care is provided during the study?
All study-related medical care related to the study is provided, including study-related exams, study-related medications and other study-related medical care. There is no insurance required to participate. All study-related medical care will be explained.
Studies may also offer compensation in return for travel.
Is it safe to participate in a clinical trial?
All clinical trials have possible risks, some of which are known before the study starts. Before deciding to participate, the study risks will be explained. Study participants are closely monitored during the study.
While side effects may occur with any investigational medication being studied, the safety and well-being of study participants are top priorities for the sponsors, doctors, nurses and research professionals who conduct clinical trials.
Study participants can decide at any point to end participation.
What about clinical trials participation during COVID-19?
This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19. Each individual site location will review their protocols including mask wearing, social distance, pre-appointment check in. Study sites are medical facilities where COVID safety procedures are followed.
The COVID-19 vaccine can be administered before entering in the study or afterwards, without needing study drug interruption. This should be discussed with your study doctor.
Can I speak with someone if I have questions?
Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will contact with you. You can ask questions at any time, before deciding to participate, during study conduct and after the end of the study.
Complete this brief questionnaire (approximately 5 minutes) to help determine if you may qualify to be referred to a site recruiting in your area for further evaluation for potential participation in this clinical study.
You can also add your contact information to be notified of future Sanofi studies.
References: Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, updated 2019, updated 2020, updated 2021.