A Study to Assess the Long-term Safety and Efficacy of Amlitelimab in Participants Aged 12 Years and Older with Moderate to Severe Atopic Dermatitis
Descrizione riassuntiva dello studio
Available AD medications are not always effective or suitable for all patients and can cause unpleasant side effects. There is a need for new treatments. In this study, researchers want to evaluate how safe and effective the investigational drug Amlitelimab is in treating AD when injected under the skin over a long period.
(BASEC)
Intervento studiato
This study is an open-label, single-arm study in which each participant will take part for up to 180 weeks. During these 180 weeks, each participant will be treated with Amlitelimab for up to 160 weeks (about 3 years). The study investigates how effective and safe the treatment with Amlitelimab is when administered over a long period. An 'open-label' study means that both participants and investigators know which medication is being administered.
At the start of the study, a dose will be selected based on the participant's weight. The participant will receive 2 injections of the selected dose at the baseline visit, followed by an injection every 4 weeks. The dose may change during the study if the participant's weight goes above or below 40 kg.
(BASEC)
Malattie studiate
Atopic Dermatitis (AD) or atopic eczema is a chronic inflammatory skin condition that causes itching and leaves red patches, typically on the face, arms, and legs. This disease can affect health, social functioning, well-being, and quality of life.
(BASEC)
- The participant must be at least 12 years old at the time of signing the informed consent form - Participants must have AD as defined by the American Academy of Dermatology (consensus criteria) for 1 year or longer at baseline - The participant must have a documented history within 6 months prior to screening showing either inadequate response to topical treatments or that they are not recommended. (BASEC)
Criteri di esclusione
- The presence of additional skin conditions related to AD (comorbidity) that would impair the ability to conduct AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) at the discretion of the investigator. - Known history or currently suspected significant suppression of the immune system (immunosuppression), including a history of infections caused by worms or pathogenic agents, despite resolution of the infection or otherwise recurrent infections with abnormal frequency or duration. - Any malignant diseases or a history of malignant diseases prior to the start of the study (except for non-melanoma skin cancer that has been removed and completely healed for more than 5 years before the start of the study). (BASEC)
Luogo dello studio
Altro
(BASEC)
Buochs
(BASEC)
Sponsor
sanofi-aventis (Suisse) sa, 3 route de Montfleury, C.P. 777. 1214 Vernier, Schweiz
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Sanofi-aventis Schweiz
0041-(0)58 440 21 00
contact.ch@cluttersanofi.comsanofi-aventis (Suisse) sa, 3 route de Montfleury, C.P. 777. 1214 Vernier, Schweiz
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
04.03.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
An Open-Label multinational, multicenter study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous Amlitelimab in participants aged 12 years and older with moderate to severe atopic dermatitis (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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