Complete this brief questionnaire

Check eligibility

Learn more about a clinical study for 
moderate to severe asthma

Asthma is a chronic inflammatory disease of the airways in the lungs that affects millions of people.

Asthma can cause bronchial 
obstruction of the respiratory tract and it is characterized by the occurrence of attacks which are episodes of wheezing and difficulty breathing.

Despite current treatment options, uncontrolled asthma continues to be an issue for many patients.

This study is looking for individuals between the ages of 18-75 who have moderate to severe asthma.

Sanofi believes that everyone should have the opportunity to participate in clinical trials, especially those who have been historically under represented. 

Complete a brief questionnaire to help determine if you may qualify to be referred to a site recruiting in your area (further evaluation will take place to know if you can participate in this clinical study).

Am I eligible?

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. 

  • The investigational medication, amlitelimab, is a new drug being developed to treat people with the immune-mediated diseases, including asthma.
  • The investigational medication is intended to work alongside with the immune system.
  • The investigational medication is not approved for treating people with asthma in an everyday clinical setting, and it can only be used in a research study like this one.
  • The investigational medication is given as an injection through a small needle placed just under your skin of your abdomen. The injections are completed at the study site every 4 weeks, approximately, during 5 months, and then every 12 weeks, approximately, during 7 months.
  • The investigational medication is randomly assigned.  You will receive either the investigational medication or placebo.  You have a 70% chance of receiving the investigational medication (different doses) or 30% chance of receiving the placebo.  You, the study doctor and study staff will not know which study treatment you receive.

What is the investigational medication?

Study Information

How long is the study?

The study will last approximately 76 weeks (18 months).
  • 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).

After treatment period, you will have the choice to continue receiving investigational medication by participate in a long term study.

How many visits will there be?

The study will have 13 visits:
  • 1 visit during the screening period to allow your doctor to confirm if you are eligible for this study.
  • 11 visits during the treatment period to assess the effect of the treatment.
  • 1 visit during end-of-study period to provide you with safety follow-up after treatment has ended.

How many people are in the study?

This study will include approximately 420 participants across 15 countries.

What is expected if I qualify and decide to participate?

  • To attend all study visits and complete study assesments. 
  • To tell the study doctor / study staff if you are thinking about stopping or modifying your medication(s) or starting any new medication(s) or leaving the study.   
  • To report immediately any side effects that you may experience or hospitalizations to your doctor / study staff.   
  • To inform the study doctor or study staff before stopping or modifying your medication(s) or before starting any new medications(s).

Am I eligible?


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 Research Ethics Boards or REBs) 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:

  • Medical supervision. Some people have a disease for which there is no approved treatment. They might join a clinical trial in the hopes of receiving an investigational medicine.
  • Contribute to future treatments. Many participants wish to help future patients. This has been reported by both patients and healthy volunteers.
  • Help improve the lives of others. Some people participate with the hope of helping others. The investigational drug or vaccine could benefit other patients and, in some cases, save lives.

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?

Before deciding to participate in a clinical study, potential participants will go through a process called "informed consent". This is designed to help the participant learn more about the clinical trial before deciding whether or not to participate. 

Potential participants are given detailed information about the study. This includes the purpose, possible risks, potential benefits, how long it will take, what procedures are required and whom to contact with any questions or issues. 

Once potential participants have no further questions, the document is signed indicating the decision to participate.  An informed consent is designed to protect the study participant. It is not a contract.  A participant can ask questions or stop participating without any reason and at any time, even before the study is over.

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:

  • Any short-term side effects
  • The optimal dose of the investigational medication
  • The timing of the investigational medication

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.

    References: Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, updated 2019, updated 2020, updated 2021.

    V1.0, 17Aug2022