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RECRUITING

NCT07225569

PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2, Dose-finding Study to Investigate the Efficacy and Safety of SAR445399 in Participants With Moderate to Severe Hidradenitis Suppurativa

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-12-29

Completion Date

2027-12-01

Last Updated

2026-05-26

Healthy Volunteers

Conditions

Hidradenitis Suppurativa

Interventions

DRUG

SAR445399

Pharmaceutical form: Solution for injection -Route of administration: Injection

DRUG

Placebo

Pharmaceutical form: Solution for injection -Route of administration: Injection

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.

Locations (58)

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

Essential Medical Research- Site Number : 8400015

Overland Park, Kansas, United States

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

Louisville, Kentucky, United States

Equity Medical- Site Number : 8400010

New York, New York, United States

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

The Woodlands, Texas, United States

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0360001

Sydney, New South Wales, Australia

Investigational Site Number : 0560002

Brussels, Belgium

Investigational Site Number : 0560001

Ghent, Belgium

Investigational Site Number : 0560004

Liège, Belgium

Investigational Site Number : 1240013

Regina, Saskatchewan, Canada

Investigational Site Number : 1560001

Beijing, China

Investigational Site Number : 1560003

Changsha, 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 : 2760005

Merzig, Germany

Investigational Site Number : 2760003

Regensburg, Germany

Investigational Site Number : 2760002

Rostock, Germany

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 : 3800004

Brescia, Italy

Investigational Site Number : 3800001

Chieti, Italy

Investigational Site Number : 3920002

Tokyo, Japan

Investigational Site Number : 3920001

Tokyo, Japan

Investigational Site Number : 7240006

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240002

Bilbao, Basque Country, 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 : 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)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (58)