Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis - EFC17559 / COAST1

This research study, called COAST1, is looking into a new medicine called amlitelimab for people aged 12 and older who have moderate to severe eczema (atopic dermatitis). Participants will receive either the new medicine or a dummy treatment (placebo) by subcutaneous injection, meaning an injection just under the skin. The main goal is to find out if amlitelimab is effective in clearing up eczema and making symptoms like itching and redness much better, and also to check if it's safe to use. This is a large study involving many clinics in different countries to get a clear picture of how well this new treatment works for a wide range of people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

147

Start

16 May 2024

Dermatitis atopic

What is this study about?

This study is investigating a new treatment called amlitelimab for moderate-to-severe eczema, also known as atopic dermatitis. Eczema is a common skin condition that causes itchy, red, dry, and cracked skin. Moderate-to-severe eczema can have a big impact on a person's daily life, affecting their sleep, concentration, and overall well-being. Current treatments often include creams and medications, but researchers are always looking for new and better ways to help people manage their symptoms.

In this study, participants aged 12 and over will receive either the new medicine, amlitelimab, or a 'dummy' treatment called a placebo. A placebo looks exactly like the real medicine but contains no active ingredients. This is a common practice in research to help scientists understand if the new medicine is genuinely working or if any improvements are due to other factors. Neither the participants nor the doctors will know who is getting which treatment, which helps to ensure the results are as fair and unbiased as possible.

Ultimately, this study aims to see if amlitelimab can significantly improve eczema symptoms, such as reducing the area and severity of eczema, clearing up the skin, and lessening the amount of itching experienced by patients. They will also be closely monitoring any side effects to make sure the treatment is safe. The information gathered from this study will help decide if amlitelimab could become a new option for people living with eczema.

Key takeaways

This study is testing a new medicine for moderate to severe eczema.
It involves people aged 18 years and older (though the clinical trial title mentions 12 years and older, the eligibility stated 18 years and older).
You would receive either the new medicine or a dummy treatment by injection.
The study aims to see how well the medicine clears skin and reduces itching, and if it's safe.
Participation involves regular clinic visits and assessments.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women.

More detailed information about your specific health condition and medical history would be needed to see if you qualify. For example, the study is for people with moderate-to-severe atopic dermatitis, which is a type of eczema. This means your eczema would need to be serious enough to meet certain criteria decided by the study doctors.

There may also be other health conditions or medications that would prevent someone from joining the study, as well as those that might be allowed as part of the study (like certain eczema creams). Your doctor or the study team would be able to check your full medical details to confirm if you are suitable.

Quick self-check

Are you 18 years old or older?
Do you have moderate-to-severe eczema (atopic dermatitis)?
Are you able to attend regular clinic appointments?
Are you willing to receive injections as part of the treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive either the new study medicine, amlitelimab, or a placebo (a dummy treatment). Both are given as an injection just under the skin.

You would have regular visits to the clinic for assessments. These visits would involve doctors checking your eczema through various scales and measurements to see how it's progressing. These assessments might include looking at how clear your skin is, how much of your body is affected by eczema, and how much itching you are experiencing. You might also be asked to complete questionnaires about how your eczema affects your daily life and mood.

The study would involve a commitment over a period of time, with follow-up appointments to monitor your health and the effects of the treatment. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail before you decide to join.

Potential risks and benefits

Taking part in any medical study comes with potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could improve your eczema symptoms more effectively than current options. However, you might also receive the placebo, which means you wouldn't get the active medicine. Potential risks could include side effects from the study medication, which would be explained in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

—
Poland
—
France
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Greece
—
Germany

Common questions

What is atopic dermatitis?

Atopic dermatitis is the medical name for eczema, a common skin condition causing dry, itchy, red, and inflamed skin.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active ingredients. It helps researchers see if the actual medicine is truly working.

What does 'randomised' and 'double-blind' mean?

Randomised means you're randomly assigned to a treatment group. Double-blind means neither you nor your doctor knows if you're getting the active medicine or the placebo, to keep the study fair.

How is the study medicine given?

The study medicine, amlitelimab, or the placebo is given as an injection just under the skin (subcutaneous injection).

Do I have to pay to join the study?

No, you don't have to pay to join a clinical trial. All study-related treatments and assessments are provided free of charge.