Study on Amlitelimab for Patients Aged 12 and Older 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 evaluate the effectiveness and safety of a treatment called amlitelimab, which is a type of protein known as a monoclonal antibody. Amlitelimab is administered through a subcutaneous injection, meaning it is injected under the skin using a pre-filled syringe. The study will compare two different dosing schedules of amlitelimab to see how well they work in maintaining the treatment response in participants aged 12 years and older who have moderate-to-severe atopic dermatitis. The study will also include a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to understand how well amlitelimab can maintain the improvement in skin condition for those who have already responded to treatment in previous studies. Participants will receive the treatment over a period of 48 weeks. During this time, the study will monitor the participants to see if they maintain their skin improvement and to check for any side effects. The study will also look at how the participants’ skin condition changes over time and whether they need any additional treatments.

In addition to amlitelimab, the study will also consider other treatments like tacrolimus and pimecrolimus, which are applied topically, meaning they are applied directly to the skin. These treatments are commonly used for managing atopic dermatitis. The study aims to provide valuable information on the long-term management of atopic dermatitis and help determine the best treatment options for maintaining skin health in individuals with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, previous participation in related studies, and body weight.

Participants must have completed a previous study related to moderate-to-severe atopic dermatitis without discontinuing the study medication.

2 treatment phase 1

Participants receive amlitelimab as a subcutaneous injection. The dosage is administered every four weeks (Q4W).

This phase aims to maintain the treatment response achieved in previous studies.

3 evaluation of treatment response

The effectiveness of the treatment is evaluated by measuring the proportion of participants who maintain a clinical response at week 48.

Various assessments are conducted to monitor skin condition and overall health.

4 treatment phase 2

Participants continue to receive amlitelimab injections, but the frequency changes to every twelve weeks (Q12W).

This phase further evaluates the long-term maintenance of treatment response.

5 final assessment

At the end of the study, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

Participants’ health and any side effects experienced during the study are reviewed.

Who Can Join the Study?

  • Participants must be at least 12 years old at the time they sign the informed consent form.
  • Must have taken part in one of the three 24-week parent studies (EFC17559, EFC17560, or EFC17561) for moderate-to-severe atopic dermatitis (a skin condition that causes itchy and inflamed skin), received the study treatment without stopping it permanently, and completed the necessary assessments during the treatment period.
  • Must be able and willing to attend study visits and follow the procedures requested by the study.
  • Body weight must be at least 25 kg (about 55 pounds).

Who Cannot Join the Study?

  • Patients who have not participated in the parent studies related to this trial.
  • Patients who do not have a diagnosis of atopic dermatitis, which is a skin condition that causes itchy and inflamed skin.
  • Patients who are not within the specified age range for the trial.
  • Patients who are not considered part of the clinical trial groups specified for this study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other medical conditions that might interfere with the study or pose a risk to their health.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
  • Patients who are taking medications that could interfere with the study treatment.
  • Patients who have a history of allergic reactions to the study medication or similar treatments.
  • Patients who have participated in another clinical trial recently, which might affect the results of this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland
IRCCS Humanitas Research Hospital Rozzano Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain
Hautarztpraxis Dr. Mihaescu Augsburg Germany
Sanatorium profesora Arenbergera Prague Czechia
Alergo Med Osrodek Badan Klinicznych Sp. z o.o. Tarnow Poland
Royalderm Agnieszka Nawrocka Warsaw Poland
Evimed Sp. z o.o. Warsaw Poland
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Nice Nice France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Klinische Forschung Osnabrueck Osnabrück Germany
Sanos A/S Gandrup Denmark
AGE Centrum s.r.o. Olomouc Czechia
IRCCS Azienda Ospedaliero Universitaria – Policlinico di Sant’Orsola Bologna Italy
Dlbldpoooylkdhvvcdwpwcx cmqlbt “jbpregukotuwiou Efeb Sofia Bulgaria
Vkklfr dzb Rzsof Uenammotmf Hdubxeod Sevilla Spain
Fvqzzwgcup Isfjk Cn Gjluge Oanjlkbr Myggpsod Poteuempcae Milan Italy
Uzrmihfdsflgvmytz Peibmclhzih Douwu Mmcezt Ancona Italy
Uuebivryjqddsvnwxiozl Mlxlexxp Adt Munster Germany
Awuwcyv Uvqfjjheqb Hdimktkk Aalborg Denmark
Nrklllxlw Amoq Nvyx Jylnd apvz Novy Jicin Czechia
Hovdjax Ppxfn D Aktpee Antony France
Puxcvkt Srz z ossb Katowice Poland
Cnwmro Hykwbsqzac Uzkbkkdgudoit Df Stkoe Adeqnbh Euytsk Porto Portugal
Rfnnkv Oxndxjf Lsul Orebro Sweden
Hjenwgqs Slfa Jxhc Di Dwt Bkuiqofli Esplugues De Llobregat Spain
Urbqwrjkbkmbfqprfjlnw Skcneegasrgaivynvu Aqa Kiel Germany
Cjryvx Harhjdzgyie Lvck Scz Pierre Benite France
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Fysqjnqmz Phwn Lb Iytbqjignxqpc Batxsljnj Dhf Hsmuxuzm Uwvcjimqelqvv Lv Pzy Madrid Spain
Cboubux Bxgyd Kkkcxyejtyk Poysjpix Sfh z ozdv Gdansk Poland
Hpjeezxz Unwcxmvxkcfem Vifeqm Dc Ljs Niyocz Granada Spain
Iqhpxrkmcx Gdphwdu Hrxyfiby Oq Tkhyxergpwos Thessaloniki Greece
Mnbzpsw Cucrkn Mwrvhyhect Phzfxv Oer Pleven Bulgaria
Ahsjega Ozsonyyfxph Usilsjfonohns Pjkwrf Pisa Italy
Adichpf Oamdubgvxhggvjqwrwrftwywq Pwpjfbhmuag Gy Rpmeegayazpq Muvhp De Cnezivu Catania Italy
Kqwqo aasdgslkw Fxaayem sxfazt Prague Czechia
Pjfeewpzba sfycyk Prague Czechia
Dvayirqiqwhj Qyasa Mainz Germany
Dhgtoumtxe Afz Cnspvbfioq Cquaco Xqryuwcfcvha Ehvy Sofia Bulgaria
Gowsyos Hxnfnksu Ox Tgwpdwdahmbv Psmdapixnpmg Thessaloniki Greece
Marqarzxtth Cjzllad Fzq Mrdvtnr Sophadg &eker Sdqqgyce Gisa Magdeburg Germany
Hliwzehnqdwqjq Dj Mbc Mdaslqhj Hpkrigwr Witten Germany
Dovrrdit Cjvafqz scoueq Plzen Czechia
Achynj Ubsyphxmjy Heghbdlm Aarhus Denmark
Asjezly Sirtqqt Hlqhaldu Ol Vmwdboub Aby Dcejytyoppveaa Dxkkesli Athens Greece
Eohhkdje bxnedzm Gdzz Hamburg Germany
Miwwvnlskfwv Hjrfwhlx Fdp Anzkco Tazqdxwuf Daq Tghv Vqusaef Ao Gabrovo Bulgaria
Cfy Cjkopczr Tvvka Cawssnhlzgc Av Uppsala Sweden
Hbnimfvp Dblio Nwtk Romans-Sur-Isere France
Vidcwt Huqffvba Nfvb Sgaerk Do Fklvkc Vigo Spain
Etco Kipftizj Shzxpwbwffkohxm gpwwk Buxtehude Germany
Hnhurqvz Dd Sbqkr Mprzt Eggail Lisbon Portugal
Anoojed Umayb Ltngjn Sacpj Sczlwgrkc N 8 Bgocll Vicenza Italy
Histufth Cib Djhuvyvbicj Slpk Lisbon Portugal
Hfskxmkr Uakfnbvxfgqxp Iobybhf Lbmgby Madrid Spain
Tnwrsfkhops uex Sefhthznidh Bpycxrgg Gber Bad Bentheim Germany
Hjnvheja Upodqpawknfth Bqgycej Bilbao Spain
Chd Oujaoyq skoucw Moravska Ostrava A Privoz Czechia
Ee Houmimsl Ulyztzinxdzed Do Gqei Cwzeema Dlv Nzemce Las Palmas De Gran Canaria Spain
Dvtyebjfidomcc Hjimzxy Gvre Hamburg Germany
Advixtaaz Mktjaql Cnxkgl Owj Dupnitsa Bulgaria
Acuqxlg Sjghsmpzv Lcaebz Aqwebdgs Sycibry Ldojavbvlgeidn L'aquila Italy
Ihjl Vgxwnijw Burjassot Spain
Ksqajvxb Myyqpfz Aq Alvsjo Sweden
Zemumhs Mjl Sfh z ojrb Lublin Poland
Kuwzb azvipstbv Kcsmj Hqth sbavax Hlouska Czechia
Myvzaxc Sjlwmzg Zugpoaqmx W Oyjfapgpy Olsztyn Poland
Cqdgxkhts Sczfy Reims France

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
08.11.2024
Czechia Czechia
Not recruiting
08.11.2024
Denmark Denmark
Not recruiting
08.11.2024
France France
Not recruiting
08.11.2024
Germany Germany
Not recruiting
08.11.2024
Greece Greece
Not recruiting
08.11.2024
Italy Italy
Not recruiting
08.11.2024
Poland Poland
Not recruiting
08.11.2024
Portugal Portugal
Not recruiting
08.11.2024
Spain Spain
Not recruiting
08.11.2024
Sweden Sweden
Not recruiting
08.11.2024

Trial locations

Amlitelimab is a medication being studied for its effectiveness in treating moderate-to-severe atopic dermatitis, a type of skin condition. In this trial, it is given as a monotherapy, meaning it is used alone without other treatments. The medication is administered through an injection under the skin. The study aims to see how well amlitelimab maintains treatment response over time in participants who have already responded to it in previous studies.

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. The condition is associated with a malfunction in the skin barrier and an overactive immune response. Environmental factors, allergens, and stress can trigger or worsen symptoms. It is not contagious and varies in severity among individuals.

Trial ID:
2023-508096-36-00
Protocol code:
EFC17600
Trial Phase:
Therapeutic confirmatory (Phase III)

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