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
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Other
(BASEC)
Buochs
(BASEC)
Sponsor
sanofi-aventis (Suisse) sa, 3 route de Montfleury, C.P. 777. 1214 Vernier, Schweiz
(BASEC)
Contact
Contact Person Switzerland
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)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
04.03.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available