RECRUITING Phase 2 ClinicalTrials.gov

A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07225569

Registry updated: 2026-10-16

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Description

This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa. The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.

Interventions

SAR445399 (Drug)
Pharmaceutical form: Solution for injection -Route of administration: Injection
Placebo (Drug)
Pharmaceutical form: Solution for injection -Route of administration: Injection

Eligibility criteria

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III. * Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit. * Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history. * Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS. * History of recurrent or recent serious infection * Known history of or suspected current immunosuppression * History of solid organ transplant or stem cell transplant. * History of splenectomy * History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured. * Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Conditions

Hidradenitis Suppurativa

Locations

Scottsdale Clinical Trials- Site Number : 8400006 — Scottsdale, Arizona, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017 — North Hollywood, California, United States
Encore Medical Research of Boynton Beach- Site Number : 8400005 — Boynton Beach, Florida, United States
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013 — Fort Lauderdale, Florida, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007 — Fort Myers, Florida, United States
Encore Medical Research - Hollywood- Site Number : 8400004 — Hollywood, Florida, United States
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014 — Miami, Florida, United States
Florida International Research Center- Site Number : 8400002 — Miami, Florida, United States
Florida Research Center- Site Number : 8400009 — Miami, Florida, United States
Advanced Clinical Research Institute- Site Number : 8400021 — Tampa, Florida, United States
Cleaver Medical Group Dermatology- Site Number : 8400008 — Cumming, Georgia, United States
First Georgia Physician Group- Site Number : 8400033 — Fayetteville, Georgia, United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019 — Skokie, Illinois, United States
Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029 — Evansville, Indiana, United States
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026 — Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001 — Boston, Massachusetts, United States
University Health Dermatology- Site Number : 8400018 — Kansas City, Missouri, United States
Equity Medical (LLC)- Site Number : 8400010 — The Bronx, New York, United States
Essential Medical Research- Site Number : 8400015 — Tulsa, Oklahoma, United States
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020 — The Woodlands, Texas, United States
Virginia Dermatology & Skin Cancer Center- Site Number : 8400024 — Norfolk, Virginia, United States
Investigational Site Number : 0320001 — Buenos Aires, Argentina
Investigational Site Number : 0320002 — Buenos Aires, Argentina
Investigational Site Number : 0320003 — Buenos Aires, Argentina
Investigational Site Number : 0360001 — Sydney, New South Wales, Australia
Investigational Site Number : 0360003 — Woodville, South Australia, Australia
Investigational Site Number : 0360002 — South Perth, Western Australia, Australia
Investigational Site Number : 0560002 — Brussels, Belgium
Investigational Site Number : 0560001 — Ghent, Belgium
Investigational Site Number : 0560004 — Liège, Belgium
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001 — Salvador, Estado de Bahia, Brazil
Hospital das Clinicas da UNICAMP- Site Number : 0760002 — Campinas, São Paulo, Brazil
Hospital Israelita Albert Einstein- Site Number : 0760004 — São Paulo, Brazil
Investigational Site Number : 1240016 — Winnipeg, Manitoba, Canada
Investigational Site Number : 1240015 — Mississauga, Ontario, Canada
Investigational Site Number : 1240001 — Richmond Hill, Ontario, Canada
Investigational Site Number : 1240014 — Toronto, Ontario, Canada
Investigational Site Number : 1240010 — Montreal, Quebec, Canada
Investigational Site Number : 1240002 — Sherbrooke, Quebec, Canada
Investigational Site Number : 1240013 — Regina, Saskatchewan, Canada
Investigational Site Number : 1240011 — Saskatoon, Saskatchewan, Canada
Investigational Site Number : 1560001 — Beijing, China
Investigational Site Number : 1560003 — Changsha, China
Investigational Site Number : 1560006 — Hangzhou, China
Investigational Site Number : 1560004 — Shanghai, China
Investigational Site Number : 1560002 — Wuhan, China
Investigational Site Number : 2500005 — Lille, France
Investigational Site Number : 2500006 — Lille, France
Investigational Site Number : 2500002 — Nantes, France
Investigational Site Number : 2500004 — Paris, France
Investigational Site Number : 2500003 — Rouen, France
Investigational Site Number : 2760004 — Blankenfelde-Mahlow, Germany
Investigational Site Number : 2760007 — Darmstadt, Germany
Investigational Site Number : 2760006 — Dresden, Germany
Investigational Site Number : 2760005 — Merzig, Germany
Investigational Site Number : 2760003 — Regensburg, Germany
Investigational Site Number : 2760002 — Rostock, Germany
Investigational Site Number : 3480002 — Budapest, Hungary
Investigational Site Number : 3480005 — Gyula, Hungary
Investigational Site Number : 3480003 — Kaposvár, Hungary
Investigational Site Number : 3480004 — Szeged, Hungary
Investigational Site Number : 3800002 — Torette, Ancona, Italy
Investigational Site Number : 3800005 — Cona, Ferrara, Italy
Investigational Site Number : 3800007 — Garbagnate Milanese, Milano, Italy
Investigational Site Number : 3800003 — Milan, Milano, Italy
Investigational Site Number : 3800004 — Brescia, Italy
Investigational Site Number : 3800001 — Chieti, Italy
Investigational Site Number : 3800006 — Pisa, Italy
Investigational Site Number : 3920004 — Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920005 — Tsukuba, Ibaraki, Japan
Investigational Site Number : 3920003 — Koshigaya, Saitama, Japan
Investigational Site Number : 3920002 — Tokyo, Japan
Investigational Site Number : 3920001 — Tokyo, Japan
Investigational Site Number : 7240002 — Bilbao, Basque Country, Spain
Investigational Site Number : 7240006 — Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240005 — Seville, Sevilla, Spain
Investigational Site Number : 7240001 — Córdoba, Spain
Investigational Site Number : 7240004 — Málaga, Spain
Investigational Site Number : 7520001 — Örebro, Sweden
Investigational Site Number : 7520002 — Uppsala, Sweden
Investigational Site Number : 7920006 — Buca, Turkey (Türkiye)
Investigational Site Number : 7920001 — Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920005 — Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920004 — Izmir, Turkey (Türkiye)
Investigational Site Number : 7920002 — Manisa, Turkey (Türkiye)
Investigational Site Number : 7920003 — Samsun, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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