SAR445399 treatment for adults with moderate to severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 dose-finding trial comparing two doses of SAR445399 to placebo in adults with moderate to severe hidradenitis suppurativa. Participants will be treated for 32 weeks (16-week double-blind period followed by a 16-week blinded extension) and followed for up to 46 weeks with a total of 16 visits. Key entry requirements include at least 6 months of HS, lesions in two or more anatomical areas with at least one site Hurley Stage II or III, and a baseline abscess and inflammatory nodule (AN) count of ≥5. The study enrolls at clinical trial sites in the United States and is sponsored by Sanofi.

Why it matters

Who can join: the full rules

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.

Where it's running

• Scottsdale Clinical Trials- Site Number : 8400006
  Scottsdale, Arizona, United States Recruiting
• Encore Medical Research of Boynton Beach- Site Number : 8400005
  Boynton Beach, Florida, United States Recruiting
• FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
  Fort Lauderdale, Florida, United States Recruiting
• Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
  Fort Myers, Florida, United States Recruiting
• Encore Medical Research - Hollywood- Site Number : 8400004
  Hollywood, Florida, United States Recruiting
• Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
  Miami, Florida, United States Recruiting

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• LAD328 in adults with hidradenitis suppurativa

  This study tests whether LAD328 works better than placebo for adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting Phase 2 Almirall, S.A. · Warsaw, Masovian Voivodeship · NCT07547813

• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

  This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

  Recruiting at 16 sites Novartis · Ancona, AN and 15 other locations · NCT07543419

• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

  Recruiting at 15 sites Novartis · Calgary, Alberta and 14 other locations · NCT07282015

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.