Study on Amlitelimab for Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis Using Topical Corticosteroids and Inadequate Response to Previous Treatments

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What is this study about?

This clinical trial is focused on studying the effects of a medication called amlitelimab in people aged 12 years and older who have moderate to severe atopic dermatitis, commonly known as eczema. Atopic dermatitis is a skin condition that causes red, itchy, and inflamed skin. The study is designed for participants who have not responded well to previous treatments, such as biologic therapies or oral medications known as Janus Kinase (JAK) inhibitors. Participants will continue using their usual topical treatments, like corticosteroids, which are creams or ointments applied to the skin to reduce inflammation.

The purpose of the study is to evaluate how effective and safe amlitelimab is when given as a subcutaneous injection, which means it is injected under the skin. The study will compare the effects of amlitelimab to a placebo, which is a substance with no active medication. Participants will be randomly assigned to receive either amlitelimab or the placebo. The study will last for a period of 36 weeks, during which participants will receive regular injections and attend scheduled visits to monitor their progress and any changes in their condition.

Throughout the study, researchers will assess various aspects of the participants’ skin condition, including the severity of eczema symptoms and the overall impact on their quality of life. The study aims to provide valuable information on whether amlitelimab can offer a new treatment option for those with moderate to severe atopic dermatitis who have not found relief with other therapies. Participants will be closely monitored for any side effects or adverse reactions to ensure their safety during the trial.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of atopic dermatitis (AD) for at least one year, and previous inadequate response to certain treatments.

Participants must be at least 12 years old and have a body weight of 25 kg or more.

2 initial assessment

An initial assessment is conducted to evaluate the severity of atopic dermatitis using scales like the Eczema Area and Severity Index (EASI) and the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD).

The assessment includes measuring the percentage of body surface area affected by AD and the intensity of symptoms such as itching.

3 treatment phase

Participants receive subcutaneous injections of amlitelimab or a placebo. The injections are administered using a pre-filled syringe.

The treatment is given alongside background topical corticosteroids, which are applied to the skin as part of the standard care for AD.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the participant’s response to the treatment. These visits include assessments of skin condition, symptom severity, and any side effects.

The primary goal is to observe improvements in the skin condition and overall quality of life over a 36-week period.

5 end of study evaluation

At the end of the study, a final evaluation is conducted to measure the overall effectiveness of the treatment.

The evaluation focuses on achieving clear or almost clear skin and a significant reduction in symptoms compared to the baseline measurements.

Who Can Join the Study?

  • Participants must be at least 12 years old.
  • Must have been diagnosed with atopic dermatitis (a type of skin condition) for at least 1 year.
  • Must have a documented history of not responding well to a previous biologic medication for atopic dermatitis or an oral JAK inhibitor (a type of medication).
  • Must have a v-IGA-AD score of 3 or 4 at the start of the study. This is a way to measure the severity of the skin condition.
  • Must have an EASI score of 16 or higher at the start of the study. This score measures the extent and severity of the skin condition.
  • The skin condition must cover 10% or more of the body surface area (BSA) at the start of the study.
  • Must have a weekly average of daily PP-NRS of 4 or higher at the start of the study. This is a way to measure itchiness.
  • Must be able and willing to attend study visits and follow study procedures.
  • Must weigh at least 25 kg (about 55 pounds).

Who Cannot Join the Study?

  • Participants who have a history of severe allergic reactions to any of the ingredients in the study medication.
  • Individuals with other skin conditions that might interfere with the study results.
  • Patients who have used certain medications recently that could affect the study outcomes.
  • People with certain infections that are not well controlled.
  • Participants who are pregnant or breastfeeding.
  • Individuals with a history of certain types of cancer.
  • Patients with significant health issues that could make participation unsafe.
  • Anyone who has participated in another clinical trial recently.
  • Individuals who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
IRCCS Humanitas Research Hospital Rozzano Italy
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Rotterdam The Netherlands
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino Turin Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Lille Lille France
Provita Sp. z o.o. Katowice Poland
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
Centrum Badan Klinicznych Pi-House Sp. z o.o. Gdansk Poland
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Hospital Universitario Virgen De Las Nieves Granada Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Centre Hospitalier Universitaire De La Reunion St Denis France
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Centre Hospitalier Le Mans Le Mans France
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warsaw Poland
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Goethe University Frankfurt Frankfurt Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Clinical Research Group Sp. z o.o. Warsaw Poland
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d’Oncología (ICO) Badalona Spain

Other Sites

Site Name City Country Status
Hiarxs Kazltlxt Bdyollxfvqg Gtvb Berlin Germany
Hvdvzvyotvrfru Dq Mnw Mxotvhyu Hvejcoch Witten Germany
Aywscen Sguidzh Hzogsifx Ov Vasgmogr Anv Dwlcjzibzfligy Dhmckdbm Athens Greece
Hqhuoyna Dfpcm Ngnj Romans-Sur-Isere France
Umiykmjvjt Ol Lulbrxg Luebeck Germany
Akropva Utyxj Lpoqdz Szkcp Svekitjkc N 8 Btjeyd Vicenza Italy
Wjadzcqcj I Bhjwlred A Sjokotjqqszv spxe Wroclaw Poland
Csgasm Ddtbfzwbqxjhw Dd Lf Psbd Eu Dv Chpkkr Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
28.05.2024
Germany Germany
Not recruiting
28.05.2024
Greece Greece
Not recruiting
28.05.2024
Italy Italy
Not recruiting
28.05.2024
Poland Poland
Not recruiting
28.05.2024
Spain Spain
Not recruiting
28.05.2024
The Netherlands The Netherlands
Not recruiting
28.05.2024

Trial locations

Amlitelimab is a medication being studied for its effectiveness in treating moderate to severe atopic dermatitis, a type of eczema. It is given by injection under the skin. The trial aims to see how well it works for people who have not had enough improvement with other treatments, such as biologic therapies or oral medications known as Janus Kinase (JAK) inhibitors.

Investigated Diseases:

Atopic Dermatitis – Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, though the severity and symptoms can vary over time. The skin may appear red, swollen, and cracked, and it can become thickened from repeated scratching. Flare-ups can occur due to various triggers, including allergens, stress, and changes in weather. The condition is often associated with other allergic disorders such as asthma and hay fever. Managing atopic dermatitis involves identifying and avoiding triggers, as well as maintaining skin hydration.

Trial ID:
2023-508099-12-00
Protocol code:
EFC17599 – AQUA
NCT ID:
NCT06241118
Trial Phase:
Therapeutic confirmatory (Phase III)

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