a phase 2 study to evaluate the efficacy and safety of sar444656 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: this is a parallel, phase 2, 3-arm study to evaluate the efficacy, safety, pk, and biological effects of sar444656 compared with placebo in adult participants with moderate to severe hs aged ≥18 to 70 years. study details include: * screening period: up to 4 weeks (30 days) * treatment duration: up to 16 weeks * follow-up period: up to 4 weeks * total study duration: up to 24 weeks * number of visits: 14


Eligibility criteria:
inclusion criteria: * participant with a history of signs and symptoms consistent with hs for at least 1 year prior to baseline. * participant must have hs lesions present in at least 2 distinct anatomic areas, one of which must be hurley stage ii or hurley stage iii. * participant must have had an inadequate response after at least one-month of oral antibiotic 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 the study as required by the study protocol. * contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those 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, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * participant with history of solid organ transplant. * participant with history of splenectomy. * participant 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. * participant with a diagnosis of chronic immune-mediated, inflammatory conditions other 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, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient 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-cardiac etiology. * participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmhg or consistent diastolic blood pressure ≥90 mmhg despite antihypertensive 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-il17 therapy, anti-il1/anti-il1 receptor therapy except for up to 20% of the total study population. furthermore, this 20% of biologic-experienced participants must fulfilled 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.