Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to assess the efficacy, safety, and tolerability of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma. DRI17509

This research study is looking into a new medication called amlitelimab for adult patients who have asthma that is moderate to severe. The main goal is to find out if this new drug can help reduce the number of severe asthma attacks you might experience over 48 weeks. We also want to understand if it improves your breathing, helps you feel more in control of your asthma, and generally improves your quality of life. The study will also carefully check for any side effects and how well people tolerate the medicine, comparing it to a dummy treatment (placebo) to see its true effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

104

Start

08 May 2024

Asthma

What is this study about?

This study aims to find a new way to help adults living with moderate to severe asthma. Asthma is a common condition that makes breathing difficult, and for some, it can lead to severe attacks that require urgent medical attention. Our researchers are investigating a new medicine called amlitelimab, which is given as an injection under the skin. We want to see if this treatment can significantly reduce the number of times people experience severe asthma attacks.

Over 48 weeks (roughly a year), we will be closely monitoring participants to see how much their asthma improves. This includes measuring how well they can breathe using a breathing test, checking how much control they feel they have over their asthma, and understanding how their daily lives are affected. We'll also be looking at whether the new medicine helps reduce things like waking up at night due to asthma or needing to use reliever inhalers often.

Understanding if a new medicine works and is safe is extremely important. By comparing amlitelimab to a placebo (an inactive dummy medicine), we can really tell if any improvements are due to the treatment itself. This study is a 'Phase II' trial, meaning it's an early but important step towards potentially making a new treatment available for asthma patients in the future.

Key takeaways

This study tests a new asthma medicine (amlitelimab) for adults with moderate to severe asthma.
The main goal is to see if it reduces severe asthma attacks over 48 weeks.
It also checks if breathing and quality of life improve.
Participants will receive either the new medicine or a dummy treatment (placebo).
Close medical monitoring and regular hospital visits are part of taking part.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. We are looking for people who have been diagnosed with moderate to severe asthma.

Both men and women can take part in this research. The study needs a range of people to get a good understanding of how the new medicine works across different individuals.

Specific medical details will be checked by the study team to make sure it's safe and appropriate for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of moderate to severe asthma?
Are you comfortable undertaking regular hospital visits?
Are you able to provide your informed consent to participate?
Are you willing to potentially receive a placebo instead of the active drug?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for 48 weeks, which is about 11 months. You will receive either the study medicine, amlitelimab, or a placebo (a dummy medicine with no active ingredients). Which one you receive will be decided by chance, like flipping a coin.

You will have regular appointments at the study clinic throughout the 48 weeks. These visits will involve various tests, such as breathing tests to see how your lungs are working, questionnaires about your asthma symptoms and how they affect your life, and blood tests. You might also be asked to keep a daily diary of your asthma symptoms. All these assessments help the doctors understand how your asthma is changing and if the medicine is having an effect. You'll have a follow-up period after the treatment ends to ensure your health is monitored.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like closer monitoring of your asthma and access to a new potential treatment before it's widely available. However, there are potential risks, such as experiencing side effects from the medication or not receiving the active treatment if you are given the placebo. All potential risks will be fully explained before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Hungary
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Unverified
Poland

Common questions

What is a 'severe exacerbation'?

A severe exacerbation is when your asthma symptoms get much worse and you need to see a doctor urgently, go to hospital, or take steroid medicines.

What is 'amlitelimab'?

Amlitelimab is the new medicine being tested in this study. It's designed to help with asthma, but it's not yet approved for general use.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps us see if the new medicine really works.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving amlitelimab or the placebo. This is called 'double-blind' and helps ensure the study results are fair.

How long will the study last?

The treatment part of the study will last for 48 weeks (around 11 months), with some follow-up after that.