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CompletedPhase 2

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

Key facts

Who runs it
Sanofi
Where
Houston, Johnston, Ocala, Phoenix, Sandy Springs, and Tampa, United StatesSee the 6 sitesAlso in 14 other countries, 46 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
86 people enrolled
Started
6 Jun 2023
Ended
9 Jan 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • SAR442970
  • Placebo
Record updated
29 January 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
  • History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  • 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
  • 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
  • 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
  • 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
  • Laboratory exclusion criteria applied; The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
  • Female participants who were breastfeeding or considering becoming pregnant during the study

Where in United States

Also in 14 other countries, 46 sites

  • Center for Clinical Studies, LTD. LLP Site Number : 8400003Houston, United StatesNo longer taking part
  • Clinical Partners, LLC Site Number : 8400010Johnston, United StatesNo longer taking part
  • Renstar Medical Research Site Number : 8400011Ocala, United StatesNo longer taking part
  • Medical Dermatology Specialists Site Number : 8400007Phoenix, United StatesNo longer taking part
  • Advanced Medical Research PC Site Number : 8400002Sandy Springs, United StatesNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • SAR442970Treatment being tested

    Participants received SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).

  • PlaceboPlacebo, for comparison

    Participants received placebo Q2W in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28).

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, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa
Record updated
29 January 2026