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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID

NCT06028230

Run by

Sanofi

People needed

70

Starts

2023-09-29

Expected to finish

2025-11-12

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cosmetic Dermatology of Orange County- Site Number : 8400024 — Anaheim, California, United States
• First OC Dermatology - Fountain Valley- Site Number : 8400007 — Fountain Valley, California, United States
• Paradigm Clinical Research - San Diego - ClinEdge - PPDS- Site Number : 8400021 — San Diego, California, United States
• Clinical Trials Management Services - Thousand Oaks- Site Number : 8400028 — Thousand Oaks, California, United States
• Advanced Dermatology and Cosmetic Care- Site Number : 8400025 — Valencia, California, United States
• Encore Medical Research of Boynton Beach- Site Number : 8400002 — Boynton Beach, Florida, United States
• Moore Clinical Research - Brandon- Site Number : 8400001 — Brandon, Florida, United States
• Encore Medical Research - 6600 Taft St- Site Number : 8400005 — Hollywood, Florida, United States
• Sullivan Dermatology- Site Number : 8400003 — Miami, Florida, United States
• ARA Professionals- Site Number : 8400023 — Miami, Florida, United States
• Encore Medical Research - Weston- Site Number : 8400010 — Weston, Florida, United States
• Dermatology Specialists Research (DS Research) - Indiana- Site Number : 8400012 — Clarksville, Indiana, United States
• Dawes Fretzin Clinical Research- Site Number : 8400011 — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center - 110 Francis St- Site Number : 8400013 — Boston, Massachusetts, United States
• Wayne Health - Dearborn- Site Number : 8400004 — Dearborn, Michigan, United States
• Revive Research Institute-1575 W Big Beaver Rd- Site Number : 8400008 — Troy, Michigan, United States
• Vial Health - DermDox Dermatology- Site Number : 8400020 — Camp Hill, Pennsylvania, United States
• Clinical Research Philadelphia,LLC- Site Number : 8400026 — Philadelphia, Pennsylvania, United States
• UPMC Montefiore- Site Number : 8400009 — Pittsburgh, Pennsylvania, United States
• Dermatology Specialists of Spokane- Site Number : 8400015 — Spokane, Washington, United States
• Investigational Site Number : 1240004 — Québec, Quebec, Canada
• Investigational Site Number : 1520002 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520003 — Independencia, Chile
• Investigational Site Number : 1520001 — Las Condes, Chile
• Clear Dermatology & Aesthetics Center- Site Number : 8400006 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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