A study to evaluate the efficacy and safety of subcutaneous amlitelimab on background topical corticosteroids therapy in participants aged 12 years and older with moderate-to-severe AD who have had an inadequate response to prior biologic therapy or an oral JAK inhibitor (AQUA)

Recruitment & Eligibility

Inclusion Criteria

Participants must be at least 12 years of age inclusive (when signing informed consent form).
Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria).
Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAK inhibitor (JAKi) therapy.
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 3 or 4 at baseline visit.
Eczema Area and Severity Index (EASI) score of 16 or higher at baseline.
AD involvement of 10% or more of body surface area (BSA) at baseline.
Weekly average of daily Peak-Pruritus Numerical Rating Scale (PP-NRS) of >= 4 at baseline visit.
Able and willing to comply with requested study visits and procedures.
Body weight >= 25 kg

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Skin co-morbidity that would adversely affect the ability to undertake AD assessments
Known history of or suspected significant current immunosuppression.
Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured > 5 years prior to baseline).
History of solid organ or stem cell transplant.
Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline.
Positive for human immunodeficiency virus, Hepatitis B or hepatitis C at screening visit.
Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB.
Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening.
History of hypersensitivity or allergy to any of the excipients or investigational medicinal product.

Study & Design

Primary Outcome Measures

Name	Time	Method
Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of >= 2 points at Week 36	Week 36	Refer to the primary outcome-1 for "vIGA-AD".
Proportion of participants reaching 75% reduction from baseline in EASI score (EASI-75) at Week 36	Week 36	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility