Under construction – not a live service
Sign in
Taking people in United StatesPhase 2

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

Key facts

Who runs it
Sanofi
Where
Boston, Boynton Beach, Cumming, Evansville, Fayetteville, Fort Lauderdale, Fort Myers, Hollywood, Kansas City, Louisville, Miami, Norfolk, North Hollywood, Scottsdale, Skokie, Tampa, The Bronx, The Woodlands, and Tulsa, United StatesSee the 21 sitesAlso in 14 other countries, 67 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
144 people, planned
Started
29 Dec 2025
Expected to end
19 Nov 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • SAR445399
  • Placebo
Record updated
16 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Participants are excluded from the study if any of the following criteria apply:

Where in United States

Also in 14 other countries, 67 sites

  • Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001Boston, United StatesTaking people
  • Encore Medical Research of Boynton Beach- Site Number : 8400005Boynton Beach, United StatesTaking people
  • Cleaver Medical Group Dermatology- Site Number : 8400008Cumming, United StatesTaking people
  • Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029Evansville, United StatesTaking people
  • First Georgia Physician Group- Site Number : 8400033Fayetteville, United StatesTaking people
  • FXM Clinical Research - Fort Lauderdale- Site Number : 8400013Fort Lauderdale, United StatesTaking people
  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007Fort Myers, United StatesTaking people
  • Encore Medical Research - Hollywood- Site Number : 8400004Hollywood, United StatesTaking people
  • University Health Dermatology- Site Number : 8400018Kansas City, United StatesTaking people
  • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026Louisville, United StatesTaking people
  • Florida International Research Center- Site Number : 8400002Miami, United StatesTaking people
  • Florida Research Center- Site Number : 8400009Miami, United StatesTaking people
  • Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014Miami, United StatesTaking people
  • Virginia Dermatology & Skin Cancer Center- Site Number : 8400024Norfolk, United StatesTaking people
  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400017North Hollywood, United StatesNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryTaking people
  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019Skokie, United StatesTaking people
  • Advanced Clinical Research Institute- Site Number : 8400021Tampa, United StatesTaking people
  • Equity Medical (LLC)- Site Number : 8400010The Bronx, United StatesTaking people
  • Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020The Woodlands, United StatesTaking people
  • Essential Medical Research- Site Number : 8400015Tulsa, United StatesTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • SAR445399 dose regimen ATreatment being tested

    Participants will receive SAR445399 dose regimen A.

    Treatment: SAR445399

  • SAR445399 dose regimen BTreatment being tested

    Participants will receive SAR445399 dose regimen B.

    Treatment: SAR445399

  • PlaceboPlacebo, for comparison

    Participants will receive SAR445399-matching placebo.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Record updated
16 October 2026