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NCT07225569PHASE2Recruiting

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

Sanofi

Start Date

12/29/2025

Completion Date

12/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

SAR445399

DRUG

Placebo

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Conditions

Hidradenitis Suppurativa

Locations

Scottsdale Clinical Trials- Site Number : 8400006

Scottsdale, Arizona 85260

United States

Carbon Health - North Hollywood - NoHo West- Site Number : 8400017

North Hollywood, California 91606

United States

Encore Medical Research of Boynton Beach- Site Number : 8400005

Boynton Beach, Florida 33436

United States

FXM Clinical Research - Fort Lauderdale- Site Number : 8400013

Fort Lauderdale, Florida 33308

United States

Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007

Fort Myers, Florida 33912

United States

Encore Medical Research - Hollywood- Site Number : 8400004

Hollywood, Florida 33024

United States

Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014

Miami, Florida 33146

United States

Florida International Research Center- Site Number : 8400002

Miami, Florida 33173

United States

Florida Research Center- Site Number : 8400009

Miami, Florida 33174

United States

Advanced Clinical Research Institute- Site Number : 8400021

Tampa, Florida 33607

United States

Cleaver Medical Group Dermatology- Site Number : 8400008

Cumming, Georgia 30040

United States

First Georgia Physician Group- Site Number : 8400033

Fayetteville, Georgia 30214

United States

Essential Medical Research- Site Number : 8400015

Overland Park, Kansas 66213

United States

Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026

Louisville, Kentucky 40241

United States

Equity Medical- Site Number : 8400010

New York, New York 10023

United States

Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020

The Woodlands, Texas 77380

United States

Investigational Site Number : 0320001

Buenos Aires, 1023

Argentina

Investigational Site Number : 0320002

Buenos Aires, 1061

Argentina

Investigational Site Number : 0360001

Sydney, New South Wales 2010

Australia

Investigational Site Number : 0560002

Brussels, 1070

Belgium

Investigational Site Number : 0560001

Ghent, 9000

Belgium

Investigational Site Number : 0560004

Liège, 4000

Belgium

Centro de Pesquisas da Clínica IBIS- Site Number : 0760001

Salvador, Estado de Bahia 41820-020

Brazil

Investigational Site Number : 1240014

Toronto, Ontario M2N 3A6

Canada

Investigational Site Number : 1240010

Montreal, Quebec H1Y 3L1

Canada

Investigational Site Number : 1240002

Sherbrooke, Quebec J1G 1X9

Canada

Investigational Site Number : 1240013

Regina, Saskatchewan S4V 1R9

Canada

Investigational Site Number : 1240011

Saskatoon, Saskatchewan S7K 0H6

Canada

Investigational Site Number : 1560001

Beijing, 100730

China

Investigational Site Number : 1560003

Changsha, 410011

China

Investigational Site Number : 1560004

Shanghai, 200040

China

Investigational Site Number : 1560002

Wuhan, 430022

China

Investigational Site Number : 2500005

Lille, 59020

France

Investigational Site Number : 2500006

Lille, 59037

France

Investigational Site Number : 2500002

Nantes, 44093

France

Investigational Site Number : 2500004

Paris, 75010

France

Investigational Site Number : 2500003

Rouen, 76031

France

Investigational Site Number : 2760004

Blankenfelde-Mahlow, 15831

Germany

Investigational Site Number : 2760007

Darmstadt, 64283

Germany

Investigational Site Number : 2760005

Merzig, 66663

Germany

Investigational Site Number : 2760003

Regensburg, 93053

Germany

Investigational Site Number : 2760002

Rostock, 18055

Germany

Investigational Site Number : 3480002

Budapest, 1085

Hungary

Investigational Site Number : 3480005

Gyula, 5700

Hungary

Investigational Site Number : 3480003

Kaposvár, 7400

Hungary

Investigational Site Number : 3480004

Szeged, 6720

Hungary

Investigational Site Number : 3800002

Torette, Ancona 60020

Italy

Investigational Site Number : 3800005

Cona, Ferrara 44124

Italy

Investigational Site Number : 3800003

Milan, Milano 20132

Italy

Investigational Site Number : 3800004

Brescia, 25123

Italy

Investigational Site Number : 3800001

Chieti, 66100

Italy

Investigational Site Number : 3920002

Tokyo, 160-0023

Japan

Investigational Site Number : 3920001

Tokyo, 173-8610

Japan

Investigational Site Number : 7240006

Barcelona, Barcelona [Barcelona] 08035

Spain

Investigational Site Number : 7240002

Bilbao, Basque Country 48013

Spain

Investigational Site Number : 7240005

Seville, Sevilla 41009

Spain

Investigational Site Number : 7240001

Córdoba, 14004

Spain

Investigational Site Number : 7240004

Málaga, 29016

Spain

Investigational Site Number : 7520001

Örebro, 701 85

Sweden

Investigational Site Number : 7520002

Uppsala, 752 37

Sweden

Investigational Site Number : 7920006

Buca, 35390

Turkey (Türkiye)

Investigational Site Number : 7920001

Istanbul, 34093

Turkey (Türkiye)

Investigational Site Number : 7920005

Istanbul, 34899

Turkey (Türkiye)

Investigational Site Number : 7920004

Izmir, 35540

Turkey (Türkiye)

Investigational Site Number : 7920002

Manisa, 45030

Turkey (Türkiye)

Investigational Site Number : 7920003

Samsun, 55139

Turkey (Türkiye)