Study on the Effectiveness and Safety of Lunsekimig (SAR443765) for Adults with Moderate to Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study will test a new treatment called lunsekimig (also known by its code name SAR443765), which is a type of protein designed to target specific parts of the immune system involved in causing the symptoms of atopic dermatitis. The trial will compare the effects of lunsekimig with a placebo to see how well it works and how safe it is for people with moderate to severe atopic dermatitis.

The purpose of the study is to evaluate how effective different doses of lunsekimig are in improving skin conditions in adults with moderate to severe atopic dermatitis. Participants in the study will receive one of three different doses of lunsekimig or a placebo, administered through an injection under the skin. The study will last for several months, during which participants will have regular check-ups to monitor their skin condition and overall health.

Throughout the study, researchers will assess changes in the severity of the skin condition using a tool called the Eczema Area and Severity Index (EASI). They will also look at other factors, such as the amount of skin affected by the condition and the impact on participants’ quality of life. The study aims to provide valuable information on the potential benefits and safety of lunsekimig for treating atopic dermatitis.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, lunsekimig, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

The study is double-blind, meaning neither you nor the study staff will know which treatment you are receiving. This helps ensure the results are unbiased.

2 initial assessment

At the beginning of the study, a detailed assessment of your skin condition will be conducted. This includes measuring the severity of your atopic dermatitis using the Eczema Area and Severity Index (EASI) score.

You will also be asked to provide information about your symptoms, such as itching and skin pain, using numerical rating scales.

3 medication administration

You will receive the study medication, lunsekimig, or placebo as a subcutaneous injection. This means the medication is injected under the skin.

The study involves three different dosing regimens, but the specific dosage and frequency will be determined by the study protocol and assigned randomly.

4 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor your skin condition and overall health. This includes repeating the EASI score and other symptom ratings.

These assessments will help track any changes in your condition and the effectiveness of the treatment.

5 end of study evaluation

At the end of the study, a final evaluation will be conducted to assess the overall impact of the treatment on your atopic dermatitis.

This includes a final EASI score and other relevant measurements to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

Participants must be between 18 and 80 years old.
Must have been diagnosed with Atopic Dermatitis (AD) for at least 1 year. Atopic Dermatitis is a condition that makes your skin red and itchy.
Must have a history within the last 6 months of either not responding well to or being advised against using creams or ointments applied to the skin.
Must have an Eczema Area and Severity Index (EASI) score of 16 or higher. This score measures the extent and severity of eczema, ranging from 0 to 72.
Must have a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4. This scale ranges from 0 to 4, where 3 means moderate and 4 means severe.
Must have eczema covering 10% or more of the body.
Must have a weekly average itch score of 4 or higher on a scale from 0 to 10.
Must have used a simple moisturizer without additives at least once daily for at least 5 out of 7 days before starting the study.

Who Cannot Join the Study?

Participants cannot have any other skin conditions that might interfere with the study.
Participants must not have used any other treatments for atopic dermatitis within a certain period before the study.
Participants should not have any serious health conditions that could affect their safety during the study.
Participants must not be pregnant or breastfeeding.
Participants should not have a history of allergic reactions to the study medication or similar medications.
Participants must not have participated in another clinical trial recently.
Participants should not have any infections that are not well controlled.
Participants must not have a history of drug or alcohol abuse.
Participants should not have any mental health conditions that might affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medicus Sp. z o.o.	Wroclaw	Poland
Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski	Poland
Sanatorium profesora Arenbergera	Prague	Czechia

Other Sites

Site Name	City	Country
Amicare Sp. z o.o. S.K.	Lodz	Poland
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Vita Longa Sp. z o.o.	Katowice	Poland
Clinical Research Group Sp. z o.o.	Warsaw	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
St-Inspire Sp. z o.o.	Mikolow	Poland
Clintrial s.r.o.	Prague	Czechia
Pratia S.A.	Skorzewo	Poland
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.	Sosnowiec	Poland
Kpgtp alkindevt Fceouin ssihtp	Prague	Czechia
Cxaytlg Ulfrq Mbvkuftgqj Memrqk	Bochnia	Poland
Lazxo Cplpwp Stvr dz Tvvemt Kbspxgcwzln da Affzkbx Kkmcnkie	Szczecin	Poland
Pnjpvob Sfg z oyxw	Katowice	Poland
Dcgkhmxnkjip Aecej	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	07.04.2025
Poland	Not recruiting	07.04.2025

Trial locations

Investigated drugs:

LUNSEKIMIG

Lunsekimig (SAR443765) is a medication being studied for its potential to help people with moderate-to-severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. This medication is given as an injection under the skin. The goal of using lunsekimig in this study is to see if it can reduce the severity of skin lesions, which are areas of damaged skin, by improving the Eczema Area and Severity Index (EASI) score. This score is a way to measure how severe the eczema is and how much of the body it affects. By participating in this study, researchers hope to find out if lunsekimig can be an effective treatment option for people suffering from this skin condition.

Investigated diseases:

Dermatitis atopic

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups and remissions, where symptoms can worsen or improve. During flare-ups, affected areas may become dry, cracked, and prone to infection. The condition is associated with a compromised skin barrier, leading to increased sensitivity to irritants and allergens. Over time, repeated scratching can cause thickening of the skin and further irritation.

Trial ID:

2024-511549-20-00

Protocol code:

DRI18252

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Lunsekimig (SAR443765) for Adults with Moderate to Severe Atopic Dermatitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?