Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A multinational, multicenter, double-blind, placebo-controlled phase 2 study to evaluate efficacy and safety of SAR444656 in adult participants with moderate to severe atopic dermatitis.

This research study is looking into a new medicine called SAR444656 for adults who have moderate to severe eczema, also known as atopic dermatitis. Eczema can make your skin dry, red, and very itchy. The main aim of this study is to find out how well SAR444656 works to improve eczema symptoms, like reducing the redness and itchiness of the skin. We also want to check if the medicine is safe and what side effects, if any, it might cause. Half the participants will get the new medicine, and the other half will get a dummy medicine (placebo), so we can accurately compare the results. This is similar to a stage 2 trial, meaning it's an early step in testing the medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

180

Start

19 Dec 2023

Dermatitis atopic

What is this study about?

This study is about a new medicine, SAR444656, for adults who have moderate to severe atopic dermatitis, which is a common type of eczema. Eczema can be very uncomfortable, causing red, inflamed, and extremely itchy skin. Researchers are hoping this new medicine could offer a better way to control these symptoms and improve the quality of life for people living with this condition.

The main goal of the study is to see how much SAR444656 can improve eczema symptoms. Doctors will measure this by looking at changes in the Eczema Area and Severity Index (EASI) score. This score helps them work out how much of your body is affected by eczema and how severe it is. They'll also be closely watching to see how the medicine affects itching, as this is a big problem for many people with eczema. Understanding these improvements is really important for developing new treatments.

Another key part of this study is to make sure SAR444656 is safe. The research team will carefully record any side effects that people experience while taking the medicine. Knowing if a medicine is safe and well-tolerated is just as important as knowing if it works. This study helps doctors understand if SAR444656 could be a good potential treatment option in the future for people with eczema.

Key takeaways

This study evaluates a new medicine (SAR444656) for moderate to severe eczema.
It aims to see how well the medicine improves skin symptoms and reduces itching.
Safety and side effects of the new medicine will be carefully monitored.
Participants will receive either the new medicine or a placebo (dummy medicine).
Open to adults aged 18 and over with appropriate eczema severity.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

You would specifically need to have moderate to severe atopic dermatitis (eczema). This means your eczema isn't just mild but significantly affects your skin and daily life. The study doctors will carefully check your eczema to make sure it meets these specific severity requirements.

There might be other health conditions or medicines you're taking that would mean you can't join for safety reasons, but the study team will discuss all of these details with you during the screening process to make sure it's the right study for you.

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?
Have you been diagnosed with moderate to severe eczema (atopic dermatitis)?
Are you able to attend regular study visits?
Are you willing to potentially receive a placebo instead of the active medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you're suitable. If you are, you would then attend a series of visits to the clinic over a period of time. At these visits, doctors would examine your skin, measure your eczema symptoms using tools like the EASI score, and ask you questions about your itching and how you're feeling.

You would be given the study medicine, SAR444656, or a dummy medicine (placebo). This would be given to you in a way decided by the study team, likely through injections or tablets, though the exact method isn't specified here. You wouldn't know if you're getting the active medicine or the placebo, and neither would your study doctor; this is what we call 'double-blind'.

Throughout the study, you'd have regular check-ups, and the doctors would monitor your health carefully, including looking for any side effects. After you finish taking the medicine, there will be follow-up visits to ensure your safety and to see how you're doing. The total length of your participation would depend on the study's design, but typically in a phase 2 study, this could be several months.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new medicine for your eczema that might improve your symptoms more than current treatments. You would also be closely monitored by medical professionals. However, there are also potential risks; the new medicine might not work for you, or it could cause side effects, some of which might be unpleasant or unexpected. There's also a chance you could receive the placebo (dummy medicine) and not the active drug. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Germany
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Unverified
Poland
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Unverified
Greece
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Unverified
Czechia

Common questions

What is 'atopic dermatitis'?

Atopic dermatitis is the medical name for eczema, a common skin condition that makes your skin red, dry, and very itchy.

What does 'double-blind' mean in a study?

It means that neither you nor your study doctor will know if you're receiving the new medicine or a dummy medicine (placebo) until the study is over. This helps make the study fair.

What is a 'placebo'?

A placebo is a dummy medicine that looks just like the real medicine but contains no active drug. It's used to compare against the new medicine to see if it's truly effective.

What is a Phase 2 study?

A Phase 2 study is an early stage of testing a new medicine in a small group of people. It helps researchers find out if the medicine works and if it's safe before wider use.

Will I get paid to participate?

The information provided doesn't mention payment. Sometimes study expenses (like travel) are covered, but you should ask the study team about this.