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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID: NCT07225569
Run by: Sanofi
People needed: 144
Starts: 2025-12-29
Expected to finish: 2027-12-01
Last updated by the study team: 2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Carbon Health - North Hollywood - NoHo West- Site Number : 8400017 — North Hollywood, California, United States (enrolling)
Encore Medical Research of Boynton Beach- Site Number : 8400005 — Boynton Beach, Florida, United States (enrolling)
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013 — Fort Lauderdale, Florida, United States (enrolling)
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007 — Fort Myers, Florida, United States (enrolling)
Encore Medical Research - Hollywood- Site Number : 8400004 — Hollywood, Florida, United States (enrolling)
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014 — Miami, Florida, United States (enrolling)
Florida International Research Center- Site Number : 8400002 — Miami, Florida, United States (enrolling)
Florida Research Center- Site Number : 8400009 — Miami, Florida, United States (enrolling)
Advanced Clinical Research Institute- Site Number : 8400021 — Tampa, Florida, United States (enrolling)
Cleaver Medical Group Dermatology- Site Number : 8400008 — Cumming, Georgia, United States (enrolling)
First Georgia Physician Group- Site Number : 8400033 — Fayetteville, Georgia, United States (enrolling)
Essential Medical Research- Site Number : 8400015 — Overland Park, Kansas, United States (enrolling)
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026 — Louisville, Kentucky, United States (enrolling)
Equity Medical- Site Number : 8400010 — New York, New York, United States (enrolling)
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020 — The Woodlands, Texas, United States (enrolling)
Investigational Site Number : 0320001 — Buenos Aires, Argentina (enrolling)
Investigational Site Number : 0320002 — Buenos Aires, Argentina (enrolling)
Investigational Site Number : 0360001 — Sydney, New South Wales, Australia (enrolling)
Investigational Site Number : 0560002 — Brussels, Belgium (enrolling)
Investigational Site Number : 0560001 — Ghent, Belgium (enrolling)
Investigational Site Number : 0560004 — Liège, Belgium (enrolling)
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001 — Salvador, Estado de Bahia, Brazil (enrolling)
Investigational Site Number : 1240014 — Toronto, Ontario, Canada (enrolling)
Investigational Site Number : 1240010 — Montreal, Quebec, Canada (enrolling)
Scottsdale Clinical Trials- Site Number : 8400006 — Scottsdale, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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