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

A vizsgálat adatai

Ki végzi

Sanofi

Azonosító

NCT06028230EU 2023-504328-25-00

A regiszteradat frissítve

2025. december 11.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

Bevonási feltételek: 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.

Kizáró feltételek: 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