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

Prior treatment

• Any active or chronic infection requiring systemic treatment within 4 weeks prior to baseline
• 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, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
• Participants had major surgery within 4 weeks prior to the screening or have planned any 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.

Other illness

• Presence of other skin conditions that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus
• Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
• History of solid organ or stem cell transplant.
• Participants with history of splenectomy.
• 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 Hg or consistent diastolic blood pressure ≥90 mm Hg despite antihypertensive medication.

Lab values

• Family history of sudden death or long QT syndrome.
• History of congenital or drug-induced long QT syndrome.

Age

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

• Participants with atopic dermatitis as defined by the American Academy of Dermatology 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 was moderate and 4 was severe) at screening and baseline visit.
• AD involvement ≥10% of BSA at screening and baseline visit
• Baseline PP-NRS ≥4
• Participants must had documented history within 6 months prior to baseline visit, of either inadequate response or inadvisability to topical medications
• Participants must had applied daily topical emollient (moisturizer) for at least the 7 consecutive days immediately before the baseline visit. Participants should continued using daily moisturizers during the study.
• Participants must be willing and completed the electronic diary for the duration of the study as required by the study protocol.
• Contraceptive used by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.