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

Study on the Efficacy and Safety of an Investigational Medication in Adults with Moderate to Severe Hidradenitis Suppurativa

Recruiting
18 years or above
All
Phase 2
144 participants needed
1 Location

Study Overview

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 30 weeks with a total of 12 visits. The treatment duration will be 16 weeks.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hidradenitis Suppurativa
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the efficacy and safety of an investigational medication in adults with moderate to severe hidradenitis suppurativa. The study compares two doses of the investigational medication to a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

Participants in this study will undergo a series of procedures, including regular health assessments and monitoring of their hidradenitis suppurativa symptoms. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the investigational medication or the placebo. This helps ensure unbiased results.

  • Who can participate: Adults with moderate to severe hidradenitis suppurativa who have had the condition for at least 6 months may participate. Participants must have lesions in at least two different body areas and have tried oral antibiotics without success. Those with certain medical conditions or a history of serious infections are not eligible.
  • Study details: Participants will receive either the investigational medication or a placebo. Participants will be monitored for changes in their symptoms and overall health.
  • Study timelines and visits: The study will last 30 weeks. The study requires 12 visits.
Updated on 16 Jan 2026. Study ID: NCT07225569

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