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

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Praglandia s.r.o. Prague Czechia
Region Oerebro Laen Orebro Sweden
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital De Santa Maria E.P.E. Lisbon Portugal
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Hospital Cuf Descobertas S.A. Lisbon Portugal
Hospital Universitario Infanta Leonor Madrid Spain
Hospital Universitario Basurto Bilbao Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Asclepius Medical Center OOD Dupnitsa Bulgaria
Killasli Medical AB Alvsjo Sweden
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Dermatologikum Hamburg GmbH Hamburg Germany
Imed Valencia Burjassot Spain
AGE Centrum s.r.o. Olomouc Czechia
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Sanos A/S Gandrup Denmark
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Politecnica Delle Marche Ancona Italy
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Aalborg University Hospital Aalborg Denmark
Eurofins bioskin GmbH Hamburg Germany
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
CTC Clinical Trial Consultants AB Uppsala Sweden
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Centre Hospitalier Universitaire De Nice Nice France
Hopital Prive D Antony Antony France
Hopitaux Drome Nord Romans-Sur-Isere France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Vithas Hospital Nosa Senora De Fatima Vigo Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Klinische Forschung Osnabrueck Osnabrück Germany
Dermafit Centrum s.r.o. Plzen Czechia
IRCCS Azienda Ospedaliero Universitaria – Policlinico di Sant’Orsola Bologna Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Miejski Szpital Zespolony W Olsztynie Olsztyn Poland
Courlancy Sante Reims France
Kcylc algphzirl Forqepe sjxeqb Prague Czechia
Dwwwehsdod Ams Ceeghknngb Cershv Xarevyochnyu Eyhz Sofia Bulgaria
Mnevdwrhclo Cckyisu Fzg Mzfgkqb Sqrmrwt &fjds Snmtikhy Gfxp Magdeburg Germany
Csabdbh Bgufl Kbnrlqlzmpe Ptsrhxmk Svz z oimy Gdansk Poland
Topoljkwwps umr Svlutxphrpb Bhjafsfg Gnat Bad Bentheim Germany
Adnxmco Sgceqjagv Lmlxzb Ainragco Slqsvjk Liydkfsumhrmwm L'aquila Italy
Hdiciqgvngbvsf Df Mcr Mxjnmcmg Huedkwau Witten Germany
Ajjevo Ucongmnerw Hfatxxkf Aarhus Denmark
Uveqsgncxuhdfdqdxbvxd Mnylrfnd Aka Munster Germany
Pclncto Sey z ohvm Katowice Poland
Fdxxszecy Pfsw Lu Isqbgjrpnjihh Bcecgeokd Dxz Hpuewkfn Upncuqpqoegwp Lu Pfe Madrid Spain
Moapcfj Ciovkc Mygourwqqh Pzrylm Oaa Pleven Bulgaria
Dpzfxmdbupdh Qiali Mainz Germany
Zghpwki Mil Syd z oyiy Lublin Poland
Kdtzp acjygsyox Kbamp Hlvk ssvjrs Hlouska Czechia

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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