Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis

Inclusion Criteria:

• Participants with atopic dermatitis as defined by the American Academy ofDermatology Consensus Criteria for at least 1 year before the baseline visit.

• EASI ≥12 at screening and at baseline visit

• vIGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) atscreening and baseline visit.

• AD involvement ≥10% of BSA at screening and baseline visit

• Baseline PP-NRS ≥4

• Participants must have documented history within 6 months prior to baseline visit,of either inadequate response or inadvisability to topical medications

• Participants must have applied daily topical emollient (moisturizer) for at leastthe 7 consecutive days immediately before the baseline visit. Participants shouldcontinue using daily moisturizers during the study.

• Participants must be willing and able to complete the electronic diary for theduration of the study as required by the study protocol.

• Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• Presence of other skin conditions that may interfere with study assessments such aspsoriasis, tinea corporis, lupus erythematosus

• Any active or chronic infection requiring systemic treatment within 4 weeks prior tobaseline

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

• History of solid organ or stem cell transplant.

• Participants with history of splenectomy.

• Participants with history of any malignancy or lymphoproliferative disease, exceptif the participant has been free from disease for ≥5 years. Successfully treatednon-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localizedcarcinoma in situ of the cervix are allowed.

• Family history of sudden death or long QT syndrome.

• History of congenital or drug-induced long QT syndrome.

• Congestive heart failure (NYHA Class 2-4), greater than Class 1 angina pectoris,acute coronary syndrome within prior 6 months, known structural heart disease.

• History of any major cardiovascular events (eg, myocardial infarction, unstableangina pectoris, coronary revascularization, stroke, or transient ischemic attack)at any time prior to screening.

• History of ventricular fibrillation, ventricular tachycardia, Torsades de Pointes,atrial fibrillation, syncope not explained by non-cardiac etiology.

• Uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mm Hgor consistent diastolic blood pressure ≥90 mm Hg despite antihypertensivemedication.

• Participants had major surgery within 4 weeks prior to the screening or have plannedany elective major surgery during the study.

• Having received any of protocol-specified prohibited therapy (Topical or systemic)within the specified timeframe prior to the baseline visit.

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