A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Inclusion Criteria:

• Participant with a history of signs and symptoms consistent with HS for at least 1year prior to baseline.

• Participant must have HS lesions present in at least 2 distinct anatomic areas, oneof which must be Hurley Stage II or Hurley Stage III.

• Participant must have had an inadequate response after at least one-month of oralantibiotic treatment for HS, as assessed by the Investigator.

• Participant must have a total AN count of ≥5 at the baseline visit.

• Participant must have a draining tunnel count of ≤20 at the baseline visit.

• Participant must be willing and able to complete the diary for the duration of thestudy as required by the study protocol.

• Contraceptive use by men with a partner of childbearing potential and women shouldbe consistent with local regulations regarding the methods of contraception forthose participating in clinical studies.

Exclusion Criteria:

• Participant with any other active skin disease or condition (eg, bacterial, fungal,or viral infection) that may interfere with assessment of HS.

• Any active or chronic infection requiring systemic treatment (eg, antibiotics,antivirals, antifungals, antihelminthics) within 30 days prior to baseline.

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

• Participant with history of solid organ transplant.

• Participant with history of splenectomy.

• Participant with history of any malignancy or lymphoproliferative disease, except ifthe 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.

• Participant with a diagnosis of chronic immune-mediated, inflammatory conditionsother than HS

• Participant with family history of sudden death or long QT syndrome.

• Participant with history of congenital or drug-induced long QT syndrome.

• Participant with congestive heart failure (New York Heart Association Class 2 to 4),greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months,known structural heart disease.

• Participant with history of any major cardiovascular events (eg, myocardialinfarction, unstable angina pectoris, coronary revascularization, stroke, ortransient ischemic attack) at any time prior to screening.

• Participant with history of ventricular fibrillation, ventricular tachycardia,torsades de pointes, atrial fibrillation, syncope not explained by non-cardiacetiology.

• Participant with uncontrolled hypertension defined as consistent systolic bloodpressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despiteantihypertensive medication.

• Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.

• Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total studypopulation. Furthermore, this 20% of biologic-experienced participants mustfulfilled one or more of the following conditions:

• Discontinued due to treatment related toxicity and/or

• Discontinuation is not related to lack or loss of therapeutic response.

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