Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Inclusion Criteria:

• Participant must be at least 12 years of age inclusive, at the time of signing theinformed consent.

• Participants must have AD as defined by the American Academy of DermatologyConsensus Criteria for 1 year or longer at baseline.

• Participant must have documented history (within 6 months prior to screening visit),of inadequate response (including inadequate efficacy or medical inadvisability) totopical treatments and/or inadequate response to systemic therapies (within 12months prior to screening visit).

• Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.

• Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3or 4 at baseline visit/Visit 2.

• AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.

• Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 atbaseline visit/Visit 2.

• Able and willing to comply with requested study visits and procedures.

• Body weight must be greater than or equal to 25 kg.

• Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.Female participants must not be pregnant or breastfeeding.

Exclusion Criteria:

• Skin co-morbidity that would adversely affect the ability to undertake ADassessments as per investigator's judgement

• Known history of or suspected significant current immunosuppression, includinghistory of invasive opportunistic or helminthic infections despite infectionresolution or otherwise recurrent infections of abnormal frequency or prolongedduration.

• Any malignancies or history of malignancies prior to baseline (except fornon-melanoma skin cancer that has been excised and completely cured for more than 5years prior to baseline).

• History of solid organ or stem cell transplant.

• Any pre-planned major elective surgery known about at baseline that in the opinionof the investigator would necessitate that IMP be permanently discontinued orrequire more than three doses to be missed.

• Severe concomitant illness that would in the Investigator's opinion inhibit theparticipant's participation in the study.

• Any medical or psychiatric condition which, in the opinion of the Investigator maypresent an unreasonable risk to the study participants as a result of his/herparticipation in this clinical study, may make participant's participationunreliable, or may interfere with study assessments.

• Any active or chronic infection including helminthic infection requiring systemictreatment within 4 weeks prior to baseline (1 week in the event of superficial skininfections); and any infection which as per Investigator's opinion precludes theparticipant's participation in the study.

• Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failureto complete non-live immunizations required by local regulation (eg, vaccination forCOVID-19) at least 14 days prior to baseline.

• Having received any of the specified therapy within the specified timeframe(s) priorto the baseline visit.

• Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at thescreening visit.

• Participants with active tuberculosis (TB), latent TB, a history of incompletelytreated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection,or who are at high risk of contracting TB (such as close contact with individualswith active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccinationwithin 12 weeks prior to Screening.

• In the Investigator's opinion, any clinically significant laboratory results fromthe clinical chemistry, hematology, coagulation, or urinalysis tests at thescreening visit.

• In the Investigator's opinion, any significant abnormality on 12-leadelectrocardiogram (ECG) at the screening visit that could be suggestive of anunstable or underlying cardio-vascular condition that could preclude theparticipant's participation in the study.

• History of hypersensitivity or allergy to any of the excipients or IMP or otherallergy that, in the opinion of the Investigator, contraindicates participation inthe study.

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