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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID: NCT05849922
Run by: Sanofi
People needed: 86
Starts: 2023-06-06
Expected to finish: 2025-01-09
Last updated by the study team: 2026-01-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Medical Dermatology Specialists Site Number : 8400007 — Phoenix, Arizona, United States
Renstar Medical Research Site Number : 8400011 — Ocala, Florida, United States
ForCare Clinical Research Site Number : 8400006 — Tampa, Florida, United States
Advanced Medical Research PC Site Number : 8400002 — Sandy Springs, Georgia, United States
Clinical Partners, LLC Site Number : 8400010 — Johnston, Rhode Island, United States
Center for Clinical Studies, LTD. LLP Site Number : 8400003 — Houston, Texas, United States
Investigational Site Number : 0360002 — Liverpool, New South Wales, Australia
Investigational Site Number : 0360003 — Woolloongabba, Queensland, Australia
Investigational Site Number : 0560001 — Leuven, Belgium
Investigational Site Number : 1240001 — Barrie, Ontario, Canada
Investigational Site Number : 1240002 — London, Ontario, Canada
Investigational Site Number : 1240004 — Newmarket, Ontario, Canada
Investigational Site Number : 1240007 — Québec, Canada
Investigational Site Number : 1520003 — Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002 — Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 2030003 — Ostrava - Poruba, Czechia
Investigational Site Number : 2030001 — Prague, Czechia
Investigational Site Number : 2030002 — Praha 5 - Motol, Czechia
Investigational Site Number : 2080001 — Roskilde, Denmark
Investigational Site Number : 2500001 — Lyon, France
Investigational Site Number : 2500002 — Nice, France
Investigational Site Number : 2500003 — Reims, France
Investigational Site Number : 2760005 — Berlin, Germany
Investigational Site Number : 2760008 — Bochum, Germany

Full record on ClinicalTrials.gov

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