EFC17599_AQUA
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 by subcutaneous injection in participants aged 18 years and older with moderate-to-severe atopic dermatitis (AD) who are on background topical corticosteroids and have had an inadequate response to prior biologic therapy or oral Janus Kinase (JAK) inhibitor treatment.
IRAS ID
1008943
Contact name
Hywel Cooper
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-508099-12
Research summary
Atopic dermatitis (AD), also called eczema, is the most common skin disorder in the developed world. Characterised by itchy skin and lesions. It can significantly impact health and quality of life affecting social functioning and psychological well-being. Treatment can depend on it’s 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 is the study drug under investigation that is able to block the primary interaction (OX40L/OX40) prevalent in the signal pathway that causes the inflammatory response of AD. It’s a human anti OX40L mAb that has been developed to address the need for new treatment options. The primary purpose of this study is to demonstrate the efficacy of amlitelimab administered by subcutaneous (SC) injection in comparison to placebo in participants aged 18 years and older with moderate-to-severe atopic dermatitis (AD) who are on concomitant topical corticosteroids and have had inadequate response to prior biologic or oral JAK inhibitors (JAKi) therapy. The primary objective is evaluated by two clinical measurement outcome scores. The first being the proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) and a reduction from the score taken at baseline of ≥2 points at Week 36. The second being the proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 36. The study contains three treatment groups with two groups receiving study drug and the other placebo. Neither the investigators nor participants will know what they receive. Treatment is given via subcutaneous (skin) injection. Study duration will be up to 56 weeks however subjects will have the opportunity to join a long term extension study of amlitelimab prior to this.
REC name
Wales REC 1
REC reference
23/WA/0292
Date of REC Opinion
8 Dec 2023
REC opinion
Further Information Favourable Opinion