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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Andere
(BASEC)
Buochs
(BASEC)
Sponsor
sanofi-aventis (Suisse) sa, 3 route de Montfleury, C.P. 777. 1214 Vernier, Schweiz
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
04.03.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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)
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Untersuchte Krankheit(en)
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Primäre und sekundäre Endpunkte
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Ergebnisse der Studie
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