Coast 2
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 18 years and older with moderate-to-severe atopic dermatitis.
IRAS ID
1008578
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-506557-38
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 (side effects).
Amlitelimab is a monoclonal antibody and has been developed to address the significant unmet medical need for treatment options.
The study includes participants diagnosed with moderate-to-severe AD for a year or longer and who did not receive much benefit from topical medications within the last 6 months and/or systemic therapies for AD within the last 12 months. The purpose of the study is to evaluate the efficacy and safety of amlitelimab given as a sub-cutaneous (under the skin) injection in participants with moderate-to-severe AD.
This study is a randomized (like flipping a coin or rolling dice to determine which treatment you will receive), double-blind, placebo-controlled study meaning that neither the participant nor study doctor will know if the participants take amlitelimab or placebo (product without active substance). The total treatment period will be 6 months and will include approximately 420 participants across 15 countries.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0759
Date of REC Opinion
4 Dec 2023
REC opinion
Further Information Favourable Opinion