Recruiting
Phase 2

SAR445399

Sponsor:

Sanofi

Code:

NCT07225569

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SAR445399

Placebo

Study Details

Brief 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.

Conditions

Hidradenitis Suppurativa

Study ID

NCT07225569

Start date

Dec 29, 2025

Status verified date

Oct, 2026

Completion date

Nov 19, 2027

Anticipated

Primary completion date

Sep 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAR445399 dose regimen A

Participants will receive SAR445399 dose regimen A.

experimental: SAR445399 dose regimen B

Participants will receive SAR445399 dose regimen B.

placebo comparator: Placebo

Participants will receive SAR445399-matching placebo.

Interventions

SAR445399

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

Placebo

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

Primary outcome measure

  • Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: Up to Week 16 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Scottsdale Clinical Trials- Site Number : 8400006

Recruiting

Scottsdale, Arizona, United States, 85260

Encore Medical Research of Boynton Beach- Site Number : 8400005

Recruiting

Boynton Beach, Florida, United States, 33436

FXM Clinical Research - Fort Lauderdale- Site Number : 8400013

Recruiting

Fort Lauderdale, Florida, United States, 33308

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

Recruiting

Fort Myers, Florida, United States, 33912

Encore Medical Research - Hollywood- Site Number : 8400004

Recruiting

Hollywood, Florida, United States, 33024

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

Recruiting

Miami, Florida, United States, 33146

Florida International Research Center- Site Number : 8400002

Recruiting

Miami, Florida, United States, 33173

Florida Research Center- Site Number : 8400009

Recruiting

Miami, Florida, United States, 33174

Advanced Clinical Research Institute- Site Number : 8400021

Recruiting

Tampa, Florida, United States, 33607

Cleaver Medical Group Dermatology- Site Number : 8400008

Recruiting

Cumming, Georgia, United States, 30040

First Georgia Physician Group- Site Number : 8400033

Recruiting

Fayetteville, Georgia, United States, 30214

NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019

Recruiting

Skokie, Illinois, United States, 60077

Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029

Recruiting

Evansville, Indiana, United States, 47708

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

Recruiting

Louisville, Kentucky, United States, 40241

Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001

Recruiting

Boston, Massachusetts, United States, 02215

University Health Dermatology- Site Number : 8400018

Recruiting

Kansas City, Missouri, United States, 64108

Equity Medical (LLC)- Site Number : 8400010

Recruiting

The Bronx, New York, United States, 10455

Essential Medical Research- Site Number : 8400015

Recruiting

Tulsa, Oklahoma, United States, 74137

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

Recruiting

The Woodlands, Texas, United States, 77380

Virginia Dermatology & Skin Cancer Center- Site Number : 8400024

Recruiting

Norfolk, Virginia, United States, 23502

Investigational Site Number : 1240016

Recruiting

Winnipeg, Manitoba, Canada, R3M 3Z4

Investigational Site Number : 1240015

Recruiting

Mississauga, Ontario, Canada, L4W 0C2

Investigational Site Number : 1240001

Recruiting

Richmond Hill, Ontario, Canada, L4B 1L1

Investigational Site Number : 1240014

Recruiting

Toronto, Ontario, Canada, M2N 3A6

Investigational Site Number : 1240010

Recruiting

Montreal, Quebec, Canada, H1Y 3L1

Investigational Site Number : 1240002

Recruiting

Sherbrooke, Quebec, Canada, J1G 1X9

Investigational Site Number : 1240013

Recruiting

Regina, Saskatchewan, Canada, S4V 1R9

Investigational Site Number : 1240011

Recruiting

Saskatoon, Saskatchewan, Canada, S7K 0H6

More Information

Sponsor

Sanofi

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.