Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 3 subcutaneous dose regimens of lunsekimig (SAR443765) in adult participants with moderate to-severe atopic dermatitis

This study is looking into a new medicine, lunsekimig, for adults who have moderate to severe eczema, also known as atopic dermatitis. The main goal is to find out how much the new medicine can improve eczema symptoms, such as redness, itching, and dryness, over 24 weeks, compared to a placebo (a dummy treatment). We will also be watching carefully to see if the medicine is safe and if participants experience any side effects. People taking part will be randomly assigned to receive different doses of lunsekimig or the placebo, and neither they nor their doctors will know which treatment they are getting.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

108

Start

09 Apr 2025

Dermatitis atopic

What is this study about?

This study is all about finding new and better ways to help adults living with moderate to severe eczema (atopic dermatitis). Eczema can be really uncomfortable, causing itchy, red, and dry skin, and can sometimes make it hard to sleep or do daily activities.

The new medicine being tested is called lunsekimig. It's given as an injection under the skin. We're trying to figure out if this medicine can make a real difference in how severe a person's eczema is and if it's safe to use. To do this fairly, some participants will receive the actual medicine, and others will get a placebo – which looks just like the real medicine but contains no active drug. This helps us ensure that any improvements seen are truly due to the medicine and not other factors.

Researchers will closely monitor participants' eczema symptoms, such as how much of their skin is affected and how itchy it is, over 24 weeks. This careful tracking helps us understand how well the medicine works at different doses. By finding effective and safe treatments, we hope to improve the quality of life for many people who struggle with eczema.

Key takeaways

Tests a new medicine (lunsekimig) for moderate to severe eczema.
Compares the new medicine against a placebo (dummy treatment).
Aims to find out how well the medicine improves eczema symptoms and if it's safe.
Study lasts 24 weeks with regular check-ups.
Both men and women, aged 18 and older, with severe eczema may be eligible.

Who may be eligible?

To join this study, you must be an adult, aged 18 or older.

You would need to have eczema that is considered moderate to severe by the study doctors. This means your eczema is causing significant problems and needs more than just basic moisturisers to manage.

Both men and women can take part in this research. The study team will assess all your health information to make sure it's safe 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?
Has a doctor told you that you have moderate to severe eczema (atopic dermatitis)?
Are you able to attend regular clinic appointments for 24 weeks?
Are you willing to receive injections under your skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of several groups. Some groups will receive the new medicine, lunsekimig, at different doses, while another group will receive a placebo (a dummy treatment). This medicine will be given as an injection under your skin.

Throughout the study, which lasts for 24 weeks, you will have regular clinic visits. During these visits, doctors and nurses will assess your eczema symptoms, like how red and itchy your skin is, and how much of your body is affected. They will also ask you questions about your sleep and any pain you might be experiencing because of your eczema. You'll likely fill out some questionnaires and have physical examinations. There will also be follow-up appointments after the 24 weeks to see how you are doing.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from the new medicine if it works well for your eczema, which could lead to fewer symptoms and improved comfort. However, there's also a chance you could receive the placebo and not get the active treatment, or the treatment might not work for you. As with all medicines, there could be side effects, some of which might not be known yet. The study team will explain all known risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Czechia
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Unverified
Poland

Common questions

What is eczema?

Eczema (atopic dermatitis) is a common skin condition that makes your skin red, itchy, and dry. It can sometimes appear as small bumps or rashes.

What does 'Phase 2b' mean?

This means the study is in a middle stage. We're trying to find the best dose of the new medicine and check its effects and safety on a larger group of people than in earlier stages.

What is a 'placebo'?

A placebo is a substance that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers understand if the new medicine is truly effective.

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

No, this is a 'blinded' study. Neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make the study results as fair as possible.

What is 'EASI score'?

EASI stands for Eczema Area and Severity Index. It's a way doctors measure how much of your skin is affected by eczema and how severe it is, like redness and scratching.