Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis on background topical corticosteroids - EFC17561 - SHORE

This research study, called SHORE, is looking into a new medication called amlitelimab. It's for people aged 12 and over who have moderate-to-severe eczema (atopic dermatitis) that isn't fully controlled by topical steroid creams. The study wants to find out if amlitelimab, given as an injection under the skin, is safe and effective in reducing eczema symptoms like redness, thickness, and itchiness. Some participants will receive the new medicine, others will get a dummy medicine (placebo), and some might continue with standard creams. Researchers will track how much symptoms improve and how participants' lives are affected over several months. This is a large study happening in many countries.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

216

Start

11 Jun 2024

Dermatitis atopic

What is this study about?

This study, known as SHORE, is a clinical trial that aims to find out if a new medicine called amlitelimab can help people aged 12 years and older who have moderate to severe eczema (also known as atopic dermatitis). Eczema is a common skin condition that causes itchy, red, dry, and inflamed skin. For many people with moderate to severe eczema, current treatments like steroid creams might not be enough to control their symptoms.

In this study, researchers want to see if amlitelimab, which is given as an injection under the skin, can reduce the severity of eczema. They will also look at how it affects bothersome symptoms like itching and how it improves a person's quality of life. Participants will be divided into different groups: some will receive the new medicine, some will get a placebo (a dummy injection that looks like the real medicine but contains no active drug), and some might continue using their usual steroid creams. This helps researchers compare the effects of the new medicine against no active treatment.

This is a 'Phase 3' study, which means it's one of the final stages of testing a new medicine before it can be considered for wider use. It's a large study involving many people in different countries, which helps to gather robust and reliable information about the medicine's effectiveness and safety. The goal is to see if amlitelimab could become a new treatment option for people living with challenging eczema.

Key takeaways

A new medicine for moderate to severe eczema is being tested.
People aged 12 and older who use steroid creams are being sought.
The medicine is given by injection under the skin.
The study compares the new medicine to a dummy injection or standard creams.
It's a large, important study to see if the medicine works and is safe.
Participants will have regular check-ups and medical care.

Who may be eligible?

To join this study, you would need to be at least 12 years old. The study is particularly looking for people with moderate to severe eczema (atopic dermatitis) that hasn't fully cleared up with standard treatments like local steroid creams.

It's important to remember that 'moderate to severe' eczema is defined by specific medical criteria, so the study team would need to check if your eczema meets those requirements. They'll also check your overall health to make sure the study is right for you and safe.

If you're interested, the study team would explain all the details and perform some checks to determine if you can participate. It's okay to ask lots of questions before deciding.

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 12 years old or older?
Have you been diagnosed with moderate to severe eczema (atopic dermatitis)?
Do you use topical steroid creams, but your eczema is still bothering you?
Are you able to attend regular clinic visits?
Are you generally willing to follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three groups by chance, like flipping a coin. You might receive the new medicine, amlitelimab, or a placebo (a dummy injection with no active medicine), or continue with standard creams (pimecrolimus or tacrolimus). Neither you nor your study doctor will know which treatment you are getting until the study is over; this helps make the results fairer.

The medicine is given as an injection under the skin. You would need to attend regular visits to the study clinic over several months. During these visits, the study team would examine your skin, ask about your symptoms (like itching), and assess your quality of life. They would also take blood samples and perform other tests to monitor your health and how the medicine is working. The total length of your participation would be explained before you join.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit if the new medicine helps your eczema or reduces its symptoms. Even if you don't receive the active medicine, you will receive close medical monitoring and care during the study. Potential risks could include side effects from the study medicine or discomfort from injections or blood tests. The study team will explain all known potential risks in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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
Germany
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Unverified
Czechia
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Unverified
Spain
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Unverified
France
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Unverified
Bulgaria

Common questions

What is amlitelimab?

Amlitelimab is a new medicine being tested for moderate to severe eczema (atopic dermatitis). It's given by injection under the skin.

What is eczema (atopic dermatitis)?

Eczema is a common skin condition causing dry, red, itchy, and irritated skin. It can range from mild to severe.

What does 'placebo-controlled' mean?

It means some participants will receive a dummy injection that looks like the real medicine but contains no active drug. This helps compare the new medicine's effects.

Who can join this study?

People aged 12 years or older with moderate to severe eczema that hasn't significantly improved with steroid creams.

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

No, this is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving until the study is finished.