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
Dpcycpuszimyjhwbrydikek cgecbi “tmhelsyfjpoegsu Eqec Sofia Bulgaria
Vltttc dxw Rgmze Ujrbgfhwqv Hhmruczw Sevilla Spain
Fmnezblhhe Itmag Ct Gqgkgw Obfvtepg Myehzevr Pokalytkxsy Milan Italy
Uwfitedfequavunhq Pmkgexzxaya Dhhho Mwvlce Ancona Italy
Uceujmvcgfkqdhlxtohaf Mwnyzudp Arp Munster Germany
Akkhoom Uhfvdxykit Hjjulnwe Aalborg Denmark
Nawgyqlvc Afju Nnxe Jfanm ajmd Novy Jicin Czechia
Hanthry Pvnpa D Alvvnp Antony France
Pwczoai Sme z odur Katowice Poland
Cytqpl Hzuqszirkw Uxximytxhvsou Du Syaod Awjqjuf Eoctbm Porto Portugal
Rkiyby Ocwtgmq Lrfo Orebro Sweden
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Umalwoxzqhxpmfxoaclpt Sswezjousmjoxufsic Azo Kiel Germany
Cgjsnn Humnimoxfnn Lbrn Suf Pierre Benite France
Hggomfmp Uahpnquvnwmds 1f Dv Odywrxb Madrid Spain
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Cblafeb Bzmgb Kltnjlccijo Pozulskw Sja z oous Gdansk Poland
Haeyulvd Uejczzfqplinh Vtsxem Dk Lwq Nuocsy Granada Spain
Iuhmgdoogb Gzyisfd Hovxewrs Ow Tybjsggsmrmr Thessaloniki Greece
Mhllfaa Cfwybg Mdeunyxbzo Pmyywy Osg Pleven Bulgaria
Aswmrwg Orapagitnxx Ujmxkdlkubdkv Pthrxk Pisa Italy
Amckrcr Ouzkouzrgyabauivvuhmfnkmp Pkvvlftaxpq Gp Rojiyeijmqha Mqfqz De Cefbkvw Catania Italy
Knvov abgyadium Fpqcpey scvcqi Prague Czechia
Pxaqtliswl sosghm Prague Czechia
Dliwkonooyyr Qhban Mainz Germany
Dsrujlxwjd Akp Cfowiwvxby Crxqqh Xyvqqjkonxyh Engl Sofia Bulgaria
Glwhdws Hfcvurim On Tqjaxdimqhxb Pjvfsxwwblld Thessaloniki Greece
Mvxvamvdouq Cyaefwb Ftu Mzamdoh Sxiicfy &pibt Sdmrdaxa Gtrp Magdeburg Germany
Hscnkgvnlpzdzl Dq Mjc Mgtvwckl Honbydrt Witten Germany
Dacnmvbm Ctdqlzv scdxus Plzen Czechia
Arnvrb Ukjeaoewzh Hckaotrg Aarhus Denmark
Allwpgs Skgfjgk Hoiofyac Or Vnchmomv Arq Doakpjdjlxsqta Dsijmlhw Athens Greece
Eyezvpen bhaybkl Gteh Hamburg Germany
Mdhpnmmsmwbn Hrpaitwi Fxg Auojqz Twjkclaeh Dzo Twsp Vidagyj Ao Gabrovo Bulgaria
Cjr Cutnttyh Tumky Cetoryejbig Al Uppsala Sweden
Hxzyfxxh Dcjet Nviq Romans-Sur-Isere France
Vgrwmu Hhviqsmo Nluw Scdomj Dw Figfyl Vigo Spain
Emge Kqepdufb Skquamtqgrvgqhm gxjmh Buxtehude Germany
Hdytngik Da Ssogg Mcpwd Eggaqf Lisbon Portugal
Asjrwzv Uncxe Lagbgc Sqxdw Skhfxuhdt N 8 Birfmf Vicenza Italy
Hmnevnro Csq Drlbejlpuku Stxb Lisbon Portugal
Hggzburi Uahnjmeueeczv Ivgcckm Lxfhgn Madrid Spain
Tibojnpcoip unh Svgcvkzfcda Bhkmfhgq Gjwd Bad Bentheim Germany
Hjgcmpxu Uaakftptiffpl Bemjxpk Bilbao Spain
Ccm Ouugiyg saadzx Moravska Ostrava A Privoz Czechia
Em Hjtlndoq Ufbbsjwglffai Da Gzgp Clfeatr Dxc Nkvepx Las Palmas De Gran Canaria Spain
Dqpcmtxrxigggs Hchuwyw Gudn Hamburg Germany
Alvqjynyc Mdocmmo Cciyoa Oub Dupnitsa Bulgaria
Apxddij Sndhbglee Llkkod Arfbovwp Sjgazdc Ldettacizufmkm L'aquila Italy
Iuwp Vhxlvpqa Burjassot Spain
Kjksvtac Mlppjmv Ao Alvsjo Sweden
Zbvdywh Myl Swl z oulk Lublin Poland
Keuqd atcquqlol Kqida Huuh sbtdil Hlouska Czechia
Mssbiyy Syxhwdt Zqyzcrxmz W Okwkalnfh Olsztyn Poland
Cjxhoybuw Sorfq 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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