LTS17789 ATLANTIS
Research type
Research Study
Full title
An Open-Label multinational, multicenter study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis.
IRAS ID
1007015
Contact name
Laetitia Ledein
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Research summary
Atopic dermatitis (AD), also known as atopic eczema, is the most common skin disorder in the developed world. Characterised by itchy skin and cutaneous (skin) lesions. The condition has a significant impact on the health and quality of life of individuals with the disease affecting social functioning and psychological well-being. Treatment of AD can depend on the extent and severity/activity of the disease, and when topical therapies (creams, ointments) are insufficient to treat signs and symptoms, systemic therapy (oral or injected medications) or phototherapy (UV exposure) are added. Amlitelimab (also known as KY1005, KY1005 2D10 or SAR445229) is the treatment/study drug under investigation that is able to block the one signal pathway that can cause the inflammatory process that leads to AD. Although several systemic treatments are available, many patients do not derive optimal benefit due to either incomplete treatment responses or due to adverse reactions. Amlitelimab, (a human anti OX40L mAb), has therefore been developed to address the significant unmet medical need for treatment options. The primary purpose of this study is to monitor the safety of amlitelimab in treating AD when given at a layer below the skin (subcutaneously) in participants aged 18 years and above, with moderate to severe AD for a year or longer and did not receive much benefit from topical medications. This study is an open-label, single-arm study with only one treatment given under the skin (subcutaneous injection).Open-label means that the participants and researchers both know which treatment is given. Each person participates for up to 180 weeks including a 160-week Amlitelimab treatment period. Local skin treatments can be used by participants during the study as needed. If necessary oral corticosteroids may also be given to participants during the study to control intolerable AD symptoms.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0027
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion