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

Last updated: January 22, 2025
Sponsor: Sanofi
Overall Status: Completed

Phase

2

Condition

Scalp Disorders

Hidradenitis Suppurativa

Rosacea

Treatment

Placebo

SAR442970

Clinical Study ID

NCT05849922
ACT16852
U1111-1280-6493
2022-502370-17
2022-502370-17-00
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with a history of signs and symptoms consistent with hidradenitissuppurativa (HS) for at least 1 year 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 inguinocrural fold), one of whichmust be Hurley Stage II or Hurley Stage III.

  • Participant must have had an inadequate response to a trial of an oral antibioticfor treatment of HS, exhibited recurrence after discontinuation of antibiotics,demonstrated intolerance to antibiotics, or has a contraindication to oralantibiotics for treatment of their HS as assessed by the Investigator throughparticipant interview and review of medical history.

  • Participants must be either biologic and small molecule immunosuppressive-naïve orTNF-experienced.

  • Participant must have a total abscess and inflammatory nodule (AN) count of ≥3 atthe Baseline visit.

  • Participant must have a draining tunnel count of ≤20 at the Baseline visit.

  • Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit.

  • Participant who is a candidate for systemic treatment per Investigator's judgment.

Exclusion

Exclusion Criteria:

  • Any other active skin disease or condition (eg, bacterial, fungal or viralinfection) that may interfere 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 killedvaccine 2 weeks prior to Baseline visit

  • History of demyelinating disease (including myelitis) or neurologic symptomssuggestive of demyelinating disease

  • Participants with a history of malignancy or lymphoproliferative disease other thanadequately treated or nonmetastatic squamous cell carcinoma, or nonmetastatic basalcell 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 participanthas a lifetime history of suicide attempt, or participant has had suicidal ideationin the past 6 months as indicated by a positive response using the screening orBaseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or asassessed by the Investigator through participant interview and review of medicalhistory

  • A history of an adverse event (AE) to anti-TNF therapy (examples include, but arenot limited, to serum sickness or anaphylaxis) for an HS or non-HS indication thatwould contraindicate readministration of an anti-TNF class therapy

  • Sensitivity to any of the study interventions, or components thereof, or drug orother allergy that, in the opinion of the Investigator, contraindicatesparticipation in the study

  • Female participants who are breastfeeding or considering becoming pregnant duringthe study

  • History (within last 2 years prior to Baseline) of prescription drug or substanceabuse, including alcohol, considered significant by the Investigator

  • Laboratory exclusion criteria apply

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

Study Design

Total Participants: 86
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 06, 2023
Estimated Completion Date:
January 09, 2025

Study Description

The study duration will be up to 40 weeks.

Connect with a study center

  • Investigational Site Number : 0360002

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Investigational Site Number: 0360002

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360005

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Investigational Site Number: 0360005

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360003

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Investigational Site Number :0360003

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360001

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Investigational Site Number :0360001

    Carlton, Victoria 3053
    Australia

    Active - Recruiting

  • Investigational Site Number : 0560001

    Leuven, 3000
    Belgium

    Site Not Available

  • Investigational Site Number : 0560002

    Sint-Lambrechts-Woluwe, 1200
    Belgium

    Site Not Available

  • Investigational Site Number : 1240001

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Investigational Site Number :1240001

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240002

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Investigational Site Number :1240002

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240004

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Investigational Site Number :1240004

    Newmarket, Ontario L3Y 5G8
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240007

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Investigational Site Number: 1240007

    Quebec, G1N 4V3
    Canada

    Active - Recruiting

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana De Santiago 7640881
    Chile

    Site Not Available

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana De Santiago 8420383
    Chile

    Site Not Available

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana De Santiago 7580206
    Chile

    Site Not Available

  • Investigational Site Number :1520001

    Santiago, Reg Metropolitana De Santiago 7640881
    Chile

    Active - Recruiting

  • Investigational Site Number :1520002

    Santiago, Reg Metropolitana De Santiago 8420383
    Chile

    Active - Recruiting

  • Investigational Site Number :1520003

    Santiago, Reg Metropolitana De Santiago 7580206
    Chile

    Active - Recruiting

  • Investigational Site Number : 2030003

    Ostrava - Poruba, 70852
    Czechia

    Site Not Available

  • Investigational Site Number : 2030001

    Praha 10, 10034
    Czechia

    Site Not Available

  • Investigational Site Number : 2030002

    Praha 5 - Motol, 15006
    Czechia

    Site Not Available

  • Investigational Site Number : 2080001

    Roskilde, 4000
    Denmark

    Site Not Available

  • Investigational Site Number : 2500001

    Lyon, 69003
    France

    Site Not Available

  • Investigational Site Number : 2500002

    Nice, 06200
    France

    Site Not Available

  • Investigational Site Number : 2500003

    Reims, 51100
    France

    Site Not Available

  • Investigational Site Number : 2500004

    Saint Mande, 94163
    France

    Site Not Available

  • Investigational Site Number : 2760005

    Berlin, 10117
    Germany

    Site Not Available

  • Investigational Site Number : 2760008

    Bochum, 44791
    Germany

    Site Not Available

  • Investigational Site Number : 2760007

    Darmstadt, 64283
    Germany

    Site Not Available

  • Investigational Site Number : 2760006

    Dessau-Roßlau, 06847
    Germany

    Site Not Available

  • Investigational Site Number : 2760002

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Investigational Site Number : 2760003

    Hamburg, 20246
    Germany

    Site Not Available

  • Investigational Site Number : 2760004

    Mainz, 55131
    Germany

    Site Not Available

  • Investigational Site Number : 2760001

    Münster, 48149
    Germany

    Site Not Available

  • Investigational Site Number : 3000001

    Athens, 16121
    Greece

    Site Not Available

  • Investigational Site Number : 3000003

    Athens, 12462
    Greece

    Site Not Available

  • Investigational Site Number : 3000002

    Thessaloniki, 54642
    Greece

    Site Not Available

  • Investigational Site Number : 3800001

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Investigational Site Number : 3800002

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • Investigational Site Number : 3800003

    Catania, 95123
    Italy

    Site Not Available

  • Investigational Site Number: 3800001

    Milano, 20122
    Italy

    Active - Recruiting

  • Investigational Site Number : 5280002

    Breda, 4818 CK
    Netherlands

    Site Not Available

  • Investigational Site Number : 5280001

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Investigational Site Number : 5280003

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Investigational Site Number : 6160001

    Warszawa, Mazowieckie 02-507
    Poland

    Site Not Available

  • Investigational Site Number : 6160004

    Lodz, 90265
    Poland

    Site Not Available

  • Investigational Site Number : 6160002

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Investigational Site Number : 6160003

    Wroclaw, 50-566
    Poland

    Site Not Available

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona] 08041
    Spain

    Site Not Available

  • Investigational Site Number : 7240006

    Madrid, Madrid, Comunidad De 28046
    Spain

    Site Not Available

  • Investigational Site Number : 7240001

    Madrid / Madrid, Madrid, Comunidad De 28007
    Spain

    Site Not Available

  • Investigational Site Number : 7240004

    Manises, Valencia 46940
    Spain

    Site Not Available

  • Investigational Site Number : 7240005

    Córdoba, 14004
    Spain

    Site Not Available

  • Investigational Site Number : 7520001

    Alvsjo, 125 44
    Sweden

    Site Not Available

  • Medical Dermatology Specialists Site Number : 8400007

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Renstar Medical Research Site Number : 8400011

    Ocala, Florida 34470
    United States

    Site Not Available

  • ForCare Clinical Research Site Number : 8400006

    Tampa, Florida 33613
    United States

    Site Not Available

  • ForCare Clinical Research_Investigational Site Number: 8400006

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Advanced Medical Research PC Site Number : 8400002

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis Site Number : 8400009

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Clinical Partners, LLC Site Number : 8400010

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP Site Number : 8400003

    Houston, Texas 77004
    United States

    Site Not Available

  • Center for Clinical Studies, LTD.LLP_Investigational Site Number: 8400003

    Houston, Texas 77004
    United States

    Active - Recruiting

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