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
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Autre
(BASEC)
Buochs
(BASEC)
Sponsor
sanofi-aventis (Suisse) sa, 3 route de Montfleury, C.P. 777. 1214 Vernier, Schweiz
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
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)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
04.03.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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