This study is closed and no longer enrolling participants.

sanofi clinical trial Have you been diagnosed with moderate to severe asthma? If so, a clinical study is looking for participants between the ages of 18-75 with moderate to severe asthma who have had at least one severe asthma attack in the past year.

This study will see how safe and effective the experimental medicine called amlitelimab is when used to treat moderate to severe uncontrolled asthma.

What is the experimental medicine?

The experimental medicine, amlitelimab, is a new medicine being developed to treat people with different immune-mediated diseases, including asthma. It is intended to work alongside the immune system.

Amlitelimab 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.

Amlitelimab is given as an injection through a small needle placed just under the skin of the abdomen. The injections are completed at the study site approximately every 4 weeks during the first 5 months, and then approximately every 12 weeks during the next 7 months.

Participants in the study will be randomly assigned to receive either amlitelimab or a placebo. There is a 70% chance of receiving amlitelimab and 30% chance of receiving the placebo, and the participants who do receive amlitelimab will be randomly assigned to 1 out of 3 amlitelimab doses. You, your study doctor, and study staff will not know if you are receiving the study medicine (or at which dose) or placebo.

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 the treatment period, you will have the choice to continue receiving amlitelimab by participating in a 3-year 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 the end-of-study period to follow-up after treatment has ended to assess your safety and wellbeing

How many people are in the study?

This study will include approximately 420 participants across 15 countries.

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