A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Inclusion Criteria:

• Participants must be 12 years of age (when signing informed consent form)

• Diagnosis of AD for at least 1 year (defined by the American Academy of DermatologyConsensus Criteria)

• Documented history (within 6 months before screening) of either inadequate responseor inadvisability to topical treatments, and/or inadequate response to systemictherapies (within 12 months before screening)

• v-IGA-AD of 3 or 4 at baseline visit

• EASI score of 16 or higher at baseline

• AD involvement of 10% or more of BSA at baseline

• Weekly average of daily 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 ADassessments

• Known history of or suspected significant current immunosuppression

• Any malignancies or history of malignancies prior to baseline (with the exception ofnon-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 systemictreatment within 4 weeks prior to baseline

• Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C atscreening 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) priorto the baseline visit

• In the Investigator's opinion, any clinically significant laboratory results orprotocol specified laboratory abnormalities at screening

• History of hypersensitivity or allergy to any of the excipients or investigationalmedicinal product (IMP)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.