This study is currently not recruiting participants.

A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa

Investigational Treatment for Hidradenitis Suppurativa: Evaluating Safety and Efficacy

Not Recruiting
18 years - 70 years
All
Phase 2
86 participants needed

Study Overview

This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.

Study Details

The study duration was up to 40 weeks.

Eligibility Criteria

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

  • Conditions: Hidradenitis Suppurativa
  • Age: 18 years - 70 years
  • Gender: All

Inclusion Criteria:

  • Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
  • Participants had to have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which had to be Hurley Stage II or Hurley Stage III.
  • Participant had to have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or had a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
  • Participants had to be either biologic and small molecule immunosuppressive-naïve or TNF-experienced.
  • Participant had to have a total abscess and inflammatory nodule (AN) count of ≥3 at the Baseline visit.
  • Participant had to have a draining tunnel count of ≤20 at the Baseline visit.
  • Participant had to have a C-reactive protein (CRP) >3 mg/L at the screening visit.
  • Participant who was a candidate for systemic treatment per Investigator's judgment.

Exclusion Criteria:

  • Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that might have interfered with assessment of HS
  • History of recurrent or recent serious infection
  • Known history of or suspected significant current immunosuppression
  • History of solid organ transplant
  • History of splenectomy
  • History of moderate to severe congestive heart failure
  • Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
  • History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
  • Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
  • Participants with a diagnosis of inflammatory conditions other than HS
  • Presence of active suicidal ideation, or positive suicide behavior or participant had a lifetime history of suicide attempt, or participant had had suicidal ideation in the past 6 months as indicated by a positive response using the screening or Baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history
  • A history of an adverse event (AE) to anti-TNF therapy (examples included, but were not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicated participation in the study
  • Female participants who were breastfeeding or considering becoming pregnant during the study
  • History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  • Laboratory exclusion criteria applied.

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

The purpose of this study is to investigate hidradenitis suppurativa. This study investigates an investigational medication compared to a placebo.

The study evaluates the effectiveness and safety of the investigational medication for hidradenitis suppurativa. It focuses on understanding how well the medication works and its safety for participants.

  • Who can participate: Adults with hidradenitis suppurativa, who have had the condition for at least one year and have lesions in at least two distinct areas, may be eligible. Participants should have tried antibiotics unsuccessfully or cannot use them.
  • Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines: The study will last 40 weeks.
Updated on 23 May 2026. Study ID: NCT05849922