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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Sanofi · Participants: 144 · Started: Dec 29, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07225569

Locations in the U.S.

ArizonaScottsdale Clinical Trials- Site Number : 8400006, Scottsdale
FloridaEncore Medical Research of Boynton Beach- Site Number : 8400005, Boynton Beach
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013, Fort Lauderdale
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007, Fort Myers
Encore Medical Research - Hollywood- Site Number : 8400004, Hollywood
Florida International Research Center- Site Number : 8400002, Miami
Florida Research Center- Site Number : 8400009, Miami
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014, Miami
Advanced Clinical Research Institute- Site Number : 8400021, Tampa
GeorgiaCleaver Medical Group Dermatology- Site Number : 8400008, Cumming
First Georgia Physician Group- Site Number : 8400033, Fayetteville
IllinoisNorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019, Skokie
IndianaDeaconess Clinic - Downtown Fourth Street- Site Number : 8400029, Evansville
KansasEssential Medical Research- Site Number : 8400015, Overland Park
KentuckyDermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026, Louisville
MassachusettsBeth Israel Deaconess Medical Center - Boston- Site Number : 8400001, Boston
MissouriUniversity Health Dermatology- Site Number : 8400018, Kansas City
New YorkEquity Medical (LLC)- Site Number : 8400010, The Bronx
TexasElligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020, The Woodlands
VirginiaVirginia Dermatology & Skin Cancer Center- Site Number : 8400024, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.