Study on the Long-Term Safety and Effectiveness of Amlitelimab for Adults with Moderate to Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying the long-term effects of a treatment for atopic dermatitis, a condition commonly known as eczema, which causes the skin to become itchy, red, and inflamed. The treatment being tested is called amlitelimab, which is given as an injection under the skin. The study aims to understand how safe and tolerable this treatment is for adults who have moderate to severe forms of atopic dermatitis.

Participants in the study will receive the amlitelimab treatment over a period of time, and researchers will monitor them to see how their condition responds. The study will also include a comparison with a group receiving a placebo, which is a substance with no active medication. This helps researchers determine the true effects of the treatment. The study will track any side effects or changes in the participants’ skin condition, as well as their overall health and quality of life.

The goal of this research is to gather information on the safety and effectiveness of amlitelimab for treating atopic dermatitis. By participating, individuals contribute to a better understanding of how this treatment can help manage the symptoms of eczema and improve the lives of those affected by this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your medical history will be reviewed to confirm eligibility. This includes checking if you have had atopic dermatitis for at least one year and if you have tried other treatments without success.

You will undergo a physical examination, and your skin condition will be assessed using specific scales to measure the severity of your dermatitis.

2 treatment administration

You will receive the medication amlitelimab as a solution for injection. This will be administered under the skin, known as a subcutaneous injection.

The frequency and dosage of the medication will be determined by the study protocol, and you will be informed about the schedule for receiving these injections.

3 regular follow-up visits

You will attend regular follow-up visits to monitor your response to the treatment. These visits will include assessments of your skin condition and any side effects you may experience.

During these visits, you will be asked to report any changes in your symptoms and overall health.

4 safety and efficacy assessments

Throughout the study, the safety of the treatment will be closely monitored. This includes checking for any adverse events or side effects that may occur.

The effectiveness of the treatment will also be evaluated by measuring changes in your skin condition and quality of life.

5 end of study procedures

At the end of the study, you will have a final visit where your overall health and skin condition will be assessed.

You will be provided with information about the results of the study and any further steps you may need to take regarding your treatment.

Who Can Join the Study?

  • Participant must be at least 18 years old at the time of signing the informed consent.
  • Participants must have had atopic dermatitis (AD) for 1 year or longer. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
  • Participant must have a documented history within 6 months before the screening visit of either not responding well to or being advised against using topical treatments. Topical treatments are medications applied directly to the skin.
  • Participant must have an Eczema Area Severity Index (EASI) score of 16 or higher at the baseline visit. The EASI is a tool used to measure the extent and severity of eczema.
  • Participant must have a Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) score of 3 or 4 at the baseline visit. This scale is used to assess the overall severity of atopic dermatitis.
  • Participant must have atopic dermatitis affecting 10% or more of their body surface area (BSA) at the baseline visit. Body surface area refers to the percentage of the body affected by the condition.
  • Participant must have a weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) score of 4 or higher at the baseline visit. This scale measures the intensity of itching.
  • Participant must be able and willing to attend study visits and follow study procedures.
  • Participants must use contraception as per local regulations. Female participants must not be pregnant or breastfeeding.

Who Cannot Join the Study?

  • Patients with any other skin conditions that might interfere with the study.
  • Patients who have had a severe allergic reaction to any medication in the past.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of certain infections, such as tuberculosis.
  • Patients who have a weakened immune system, which means their body has a harder time fighting infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received certain vaccines recently.
  • Patients who have a history of cancer, except for some types of skin cancer.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Clinical Research Group Sp. z o.o. Warsaw Poland
Clintrial s.r.o. Prague Czechia
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Centre Hospitalier Universitaire De Nantes Nantes France
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Amphia Hospital Breda The Netherlands
Universita Degli Studi Di Brescia Brescia Italy
Fakultni Nemocnice Bulovka Prague Czechia
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Klinische Forschung Osnabrueck Osnabrück Germany
Kgkbq awadcqrsj Fjlreqz sciqxt Prague Czechia
Asttlcekpr Ptbzgish Hkhtcwic Dn Pmivv Paris France
Ldyknoc Sybnwhlgqoymlmp Gbtucgw Drijvhxdkjjfzef Lublin Poland
Pwgm Twkxw Hiwyfosr Uolggiuyazeq Sabadell Spain
Dpvygnpmid Mljxsee Dbnxeupicar Cfvmdz Du Nx Mmyn Edepo Gpvaxn Chorzow Poland
Hsenlztypplwwi Db Mkk Mzlpuopz Hhbgizyl Witten Germany
Axnlcbteds Pwqzlmpk Hrtqeorl Do Mzhxyzaee Marseille France
Emaehtr Uefckjnpdfoz Minvpcl Ctdatab Rtlvgoeeu (uhubmxg Mgr Rotterdam The Netherlands
Adufxa Ugjgktjpng Htoupson Aarhus Denmark
Uzqyukppmbmbptqqzjvpn Mvdovlsg Apy Munster Germany
Pzyhteh Sya z ortd Katowice Poland
Ubxkuuxbja Dwgqp Sjgrw Dq Reha Lu Suqcncoe Rome Italy
Fqzbhwjra Prqj Lo Imzrhlfaszyax Busdclnea Dus Hsdyvpgr Uqbtvejfriqpg Lp Pnh Madrid Spain
Cqerspo Bxdlu Koxqegbbcny Pxxkemwq Sst z omzf Gdansk Poland
Tzfrtkuttvp umh Sytexqyoybt Bdxpszxp Gcvy Bad Bentheim Germany
Hnqomfwi Ukkcasikvmppa Hrosxtlr Toncu y Pczcci Iuzldevd Clmszv daaknnlstwcxqpeoy (javo Badalona Spain
Hstlrhp Hosse Mopgoo &fptugc 1 rac Gnktqru Enxpda Creteil France

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
16.08.2023
Denmark Denmark
Not recruiting
16.08.2023
France France
Not recruiting
16.08.2023
Germany Germany
Not recruiting
16.08.2023
Italy Italy
Not recruiting
16.08.2023
Poland Poland
Not recruiting
16.08.2023
Spain Spain
Not recruiting
16.08.2023
The Netherlands The Netherlands
Not recruiting
16.08.2023

Trial locations

Investigated drugs:

Amlitelimab 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 main goal of using amlitelimab in this study is to see how safe it is for long-term use and how well it can help manage the symptoms of atopic dermatitis. Participants in the trial receive this medication to see if it can improve their skin condition over time without causing significant side effects.

Investigated diseases:

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin barrier is compromised, leading to increased sensitivity and susceptibility to infections. It commonly affects areas such as the face, neck, and the insides of elbows and knees. The condition is associated with other allergic disorders like asthma and hay fever. Over time, repeated scratching can lead to thickened skin and further irritation.

Trial ID:
2022-502188-39-00
Protocol code:
LTS17789 / ATLANTIS
NCT ID:
NCT05769777
Trial Phase:
Therapeutic exploratory (Phase II)

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