Study on Long-Term Safety and Efficacy of Amlitelimab for Patients with Moderate to Severe Atopic Dermatitis from Previous Trials

4 1 1 1

What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called amlitelimab for people with atopic dermatitis, which is a type of eczema that causes itchy and inflamed skin. The study is designed for participants who have already taken part in previous trials involving amlitelimab for moderate to severe atopic dermatitis. Amlitelimab is administered as a solution for injection under the skin, known as a subcutaneous injection. The purpose of this study is to gather more information about how safe and tolerable amlitelimab is when used over a longer period.

Participants in this study will continue to receive amlitelimab and will be monitored for any side effects or changes in their condition. The study will also compare amlitelimab with other treatments, including agents for dermatitis that do not contain steroids, glucocorticoids, and plain corticosteroids. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the effects of amlitelimab more clearly. The study will track the percentage of participants who experience any adverse events, which are unwanted effects that occur during treatment.

The trial will last for several years, allowing researchers to observe the long-term impact of amlitelimab on atopic dermatitis. Participants will have regular visits to assess their skin condition and overall health. The study aims to provide valuable insights into how amlitelimab can help manage atopic dermatitis over time, potentially improving the quality of life for those affected by this chronic skin condition.

1 enrollment

Upon joining the study, the participant will be enrolled in a long-term extension study. This study is designed to evaluate the long-term safety, tolerability, and effectiveness of a medication called amlitelimab for individuals with moderate to severe atopic dermatitis.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes verifying that the participant has previously participated in an amlitelimab clinical trial and has completed the necessary assessments during the treatment period of that trial.

3 treatment administration

Participants will receive amlitelimab through a subcutaneous injection. The dosage, frequency, and duration of administration will be determined based on the participant’s previous trial experience and the study protocol.

4 regular follow-up visits

Participants will attend regular follow-up visits to monitor their response to the treatment. During these visits, various assessments will be conducted to evaluate the safety and effectiveness of the treatment.

5 monitoring for adverse events

Throughout the study, participants will be monitored for any treatment-emergent adverse events (TEAEs). These are any unwanted effects that occur after starting the treatment. Participants are encouraged to report any new symptoms or changes in their condition.

6 completion of study

Upon completion of the study, participants will undergo a final assessment. This will include a review of their overall health and any changes in their atopic dermatitis condition.

Who Can Join the Study?

  • Participant must be at least 12 years old at the time of signing the consent form.
  • Participant must have taken part in a previous clinical trial for moderate to severe atopic dermatitis (a type of skin condition) and received the study treatment. They must have completed the necessary assessments during the treatment period.
  • Participant must have reached the specific time point to join this study at the last visit of their previous study.
  • Participant must provide signed informed consent and be able to follow the study requirements.
  • Participant must have followed the previous clinical trial rules to the satisfaction of the study doctor.
  • Participant’s body weight must be at least 25 kg (about 55 pounds).

Who Cannot Join the Study?

  • Participants with any other skin conditions that might interfere with the study.
  • Participants who have had a severe allergic reaction to any medication in the past.
  • Participants who are currently taking part in another clinical trial.
  • Participants who have a history of certain immune system disorders.
  • Participants who are pregnant or breastfeeding.
  • Participants with a history of drug or alcohol abuse.
  • Participants with any serious medical conditions that are not well controlled.
  • Participants who have received certain treatments for dermatitis within a specific time frame before the study.
  • Participants who have been vaccinated with a live vaccine within a certain period before the study.
  • Participants who have had a major surgery recently.

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
Centre Hospitalier Universitaire Rouen Rouen France
IRCCS Humanitas Research Hospital Rozzano Italy
University Of Debrecen Debrecen Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
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
Universitaetsklinikum Muenster AöR Munster Germany
Aalborg University Hospital Aalborg Denmark
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Lille Lille France
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Provita Sp. z o.o. Katowice Poland
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Oncopole Claudius Regaud Toulouse France
Region Oerebro Laen Orebro Sweden
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Technische Universitaet Dresden Dresden Germany
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid 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
Hospital Universitario De Navarra Pamplona Spain
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Medical Center Medconsult Pleven OOD Pleven Bulgaria
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Centre Hospitalier Universitaire De La Reunion St Denis France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Clintrial s.r.o. Prague Czechia
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Praglandia s.r.o. Prague Czechia
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Sanos A/S Gandrup Denmark
Royalderm Agnieszka Nawrocka Warsaw Poland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Synexus Polska Sp. z o.o. Poznan Poland
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
Vithas Hospital Nosa Senora De Fatima Vigo Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Hospital Universitario Infanta Leonor Madrid Spain
Thermalsole und Schwefelbad Bentheim GmbH Bad Bentheim Germany
Hospital Universitario Basurto Bilbao Spain
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
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
Aarhus University Hospital Aarhus Denmark

Other Sites

Site Name City Country Status
Pratia Prague s.r.o. Prague Czechia
SYNEXUS Magyarorszag Kft. Budapest Hungary
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Hautarztpraxis Dr. Mihaescu Augsburg Germany
Sanatorium profesora Arenbergera Prague Czechia
Pratia S.A. Skorzewo Poland
Evimed Sp. z o.o. Warsaw Poland
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
Pratia Brno s.r.o. Brno-Stred Czechia
AGE Centrum s.r.o. Olomouc Czechia
Msruhnhsn Iadzlsrdqx Cwdpfkco Snbjeiqk Svc z ocgc Warsaw Poland
Hajocss Pvxes D Amjwka Antony France
Catcmzlf Hmxnvkopnuzj Uscfjmmmujqik Dc Pplekvxqaz Pontevedra Spain
Keaww atojwgojt Fidtmnf svclnh Prague Czechia
Adhdyuvbmgkm Bqjrj Kqdp Szolnok Hungary
Dtlffposkvyy Qovll Mainz Germany
Dlrduugwsu Asr Cunjmfkreo Ckzrcf Xywcbqakaqmr Euhz Sofia Bulgaria
Hupbvtmqljbqcr Dm Mqe Muvxlxwo Hlhxhbzv Witten Germany
Dwfifoww Cncfmxv slppwx Plzen Czechia
Apxubyt Sdexwie Hrhntufp Of Vinyiglu Azh Dvpigblklihkmi Dyxfawic Athens Greece
Edzonjac bdcdghd Ginz Hamburg Germany
Hyoyyicv Dbfuc Nlve Romans-Sur-Isere France
Dgjrfpkcsr Sak z ovxz Wroclaw Poland
Sxd Wgjqrsazymdpv Glnz Gqij Gera Germany
Hvfabxyl Df Sckqc Mlbub Eietkw Lisbon Portugal
Abodayd Uimib Ltpiiq Sftku Ssgacvwzj N 8 Bfngdu Vicenza Italy
Wujqkkuvd I Bxawntgu A Ssmszrszhcap swjr Wroclaw Poland
Ttnub Pbptdocfboc Sdhtwnawclla Cytbhmo Mcysavze Sdq z obot Szczecin Poland
Svgssuw Cojyr swywpx Prague Czechia
Mbkguou Ckwjkd Skaxlmt Snamb Eqxe Sofia Bulgaria
Hysgzigj Ceo Dzgwbsjhprj Sejb Lisbon Portugal
Cnr Oxdaosy snywit Moravska Ostrava A Privoz Czechia
Dqdaaxkzseetej Hbwsxje Gahd Hamburg Germany
Cufsbum Mcxlnpkv Ahgyaao Blncjof Ksuyiwzbl Cracow Poland
Auirmaemq Mbszlqp Cubzhl Ouy Dupnitsa Bulgaria
Ahnyxgn Suokgztba Llvuop Ahmlsxuf Sqebksx Lohzawjhjaoqmf L'aquila Italy
Ikzg Vulpdsji Burjassot Spain
Ksfxjqlo Mrsgfen Aw Alvsjo Sweden
Cgqgtt Djcowmchimytl Dj Ld Poyk Ej Da Ctqgpf Paris France
Zkoqcqs Mnu Sep z ozxx Lublin Poland
Krxwh ajsypxiqf Keyti Hyhy spyfzj Hlouska Czechia
Ctswyjmow Sikje Reims France
Dgswcjctkkzgifetdyfx Mpqjsnzr slc Lodz Poland

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
10.11.2022
Czechia Czechia
Not recruiting
10.11.2022
Denmark Denmark
Not recruiting
10.11.2022
France France
Not recruiting
10.11.2022
Germany Germany
Not recruiting
10.11.2022
Greece Greece
Not recruiting
10.11.2022
Hungary Hungary
Not recruiting
10.11.2022
Italy Italy
Not recruiting
10.11.2022
Poland Poland
Not recruiting
10.11.2022
Portugal Portugal
Not recruiting
10.11.2022
Spain Spain
Not recruiting
10.11.2022
Sweden Sweden
Not recruiting
10.11.2022
The Netherlands The Netherlands
Not recruiting
10.11.2022

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 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 works in managing the symptoms of atopic dermatitis. Participants in this study have already taken part in previous trials with amlitelimab, and this study aims to continue monitoring its effects over a longer period.

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become dry, cracked, and prone to infections due to scratching. Over time, repeated scratching can lead to thickened skin and changes in skin texture. The condition is associated with a malfunction in the skin barrier and an overactive immune response. Environmental factors, allergens, and stress can exacerbate symptoms.

Trial ID:
2023-506548-18-00
Protocol code:
LTS17367
Trial Phase:
Therapeutic use (Phase IV)

Other Trials to Consider

  • Study of Camoteskimab and Sodium Chloride Placebo in Adults with Moderate-to-Severe Atopic Dermatitis

    Recruiting

    2 1 1
    Investigated Diseases:
    Investigated Drugs:
    Bulgaria Czechia Germany Hungary Poland Spain
  • Long-Term Safety and Efficacy of Lebrikizumab in Children and Adolescents With Moderate-to-Severe Atopic Dermatitis

    Recruiting

    3 1
    Investigated Diseases:
    Investigated Drugs:
    Czechia France Germany Poland Spain