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SAR445399 treatment for adults with moderate to severe hidradenitis suppurativa

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

Phase 2 Interventional Sanofi · NCT07225569

This will test two doses of SAR445399 versus placebo in adults with moderate to severe hidradenitis suppurativa to see if it reduces abscesses and inflammatory nodules and is safe.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment144 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Locations46 sites (Scottsdale, Arizona and 45 other locations)
Trial IDNCT07225569 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with at least 6 months of hidradenitis suppurativa, lesions in two or more areas (one at Hurley Stage II or III), a baseline AN count ≥5, and prior inadequate response or intolerance to oral antibiotics are the intended participants.

Not a fit: People with only mild hidradenitis suppurativa, fewer than 5 abscesses/inflammatory nodules at baseline, or those unable to attend frequent clinic visits or stop prohibited therapies are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, SAR445399 could reduce lesion counts and flares and improve symptoms and quality of life for people with moderate to severe hidradenitis suppurativa.

How similar studies have performed: Other biologic treatments such as TNF inhibitors have shown benefit in hidradenitis suppurativa, but SAR445399 is a novel agent and its efficacy and optimal dose are not yet established.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis Suppurativa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.