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

Trial details

Who runs it

Sanofi

Trial code

NCT06028230EU 2023-504328-25-00

Record updated

11 December 2025

Original description

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.Read full original descriptionShow less

A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

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

Inclusion: 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: Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline; 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 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; Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS; 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 a diagnosis of chronic immune-mediated, inflammatory conditions other than HS; 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 with family history of sudden death or long QT syndrome; Participant with history of congenital or drug-induced long QT syndrome; 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.

ClinicalTrials.gov NCT06028230 · EU CTIS 2023-504328-25-00