Phase
Condition
Scalp Disorders
Hidradenitis Suppurativa
Rosacea
Treatment
Placebo
SAR442970
Clinical Study ID
Ages 18-70 All Genders
Study Summary
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
Study Description
Connect with a study center
Investigational Site Number : 0360002
Liverpool, New South Wales 2170
AustraliaSite Not Available
Investigational Site Number: 0360002
Liverpool, New South Wales 2170
AustraliaActive - Recruiting
Investigational Site Number : 0360005
Westmead, New South Wales 2145
AustraliaSite Not Available
Investigational Site Number: 0360005
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Investigational Site Number : 0360003
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Investigational Site Number :0360003
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Investigational Site Number : 0360001
Carlton, Victoria 3053
AustraliaSite Not Available
Investigational Site Number :0360001
Carlton, Victoria 3053
AustraliaActive - Recruiting
Investigational Site Number : 0560001
Leuven, 3000
BelgiumSite Not Available
Investigational Site Number : 0560002
Sint-Lambrechts-Woluwe, 1200
BelgiumSite Not Available
Investigational Site Number : 1240001
Barrie, Ontario L4M 7G1
CanadaSite Not Available
Investigational Site Number :1240001
Barrie, Ontario L4M 7G1
CanadaActive - Recruiting
Investigational Site Number : 1240002
London, Ontario N6H 5L5
CanadaSite Not Available
Investigational Site Number :1240002
London, Ontario N6H 5L5
CanadaActive - Recruiting
Investigational Site Number : 1240004
Newmarket, Ontario L3Y 5G8
CanadaSite Not Available
Investigational Site Number :1240004
Newmarket, Ontario L3Y 5G8
CanadaActive - Recruiting
Investigational Site Number : 1240007
Quebec, G1V 4T3
CanadaSite Not Available
Investigational Site Number: 1240007
Quebec, G1N 4V3
CanadaActive - Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana De Santiago 7640881
ChileSite Not Available
Investigational Site Number : 1520002
Santiago, Reg Metropolitana De Santiago 8420383
ChileSite Not Available
Investigational Site Number : 1520003
Santiago, Reg Metropolitana De Santiago 7580206
ChileSite Not Available
Investigational Site Number :1520001
Santiago, Reg Metropolitana De Santiago 7640881
ChileActive - Recruiting
Investigational Site Number :1520002
Santiago, Reg Metropolitana De Santiago 8420383
ChileActive - Recruiting
Investigational Site Number :1520003
Santiago, Reg Metropolitana De Santiago 7580206
ChileActive - Recruiting
Investigational Site Number : 2030003
Ostrava - Poruba, 70852
CzechiaSite Not Available
Investigational Site Number : 2030001
Praha 10, 10034
CzechiaSite Not Available
Investigational Site Number : 2030002
Praha 5 - Motol, 15006
CzechiaSite Not Available
Investigational Site Number : 2080001
Roskilde, 4000
DenmarkSite Not Available
Investigational Site Number : 2500001
Lyon, 69003
FranceSite Not Available
Investigational Site Number : 2500002
Nice, 06200
FranceSite Not Available
Investigational Site Number : 2500003
Reims, 51100
FranceSite Not Available
Investigational Site Number : 2500004
Saint Mande, 94163
FranceSite Not Available
Investigational Site Number : 2760005
Berlin, 10117
GermanySite Not Available
Investigational Site Number : 2760008
Bochum, 44791
GermanySite Not Available
Investigational Site Number : 2760007
Darmstadt, 64283
GermanySite Not Available
Investigational Site Number : 2760006
Dessau-Roßlau, 06847
GermanySite Not Available
Investigational Site Number : 2760002
Frankfurt am Main, 60590
GermanySite Not Available
Investigational Site Number : 2760003
Hamburg, 20246
GermanySite Not Available
Investigational Site Number : 2760004
Mainz, 55131
GermanySite Not Available
Investigational Site Number : 2760001
Münster, 48149
GermanySite Not Available
Investigational Site Number : 3000001
Athens, 16121
GreeceSite Not Available
Investigational Site Number : 3000003
Athens, 12462
GreeceSite Not Available
Investigational Site Number : 3000002
Thessaloniki, 54642
GreeceSite Not Available
Investigational Site Number : 3800001
Milano, Lombardia 20122
ItalySite Not Available
Investigational Site Number : 3800002
Rozzano, Lombardia 20089
ItalySite Not Available
Investigational Site Number : 3800003
Catania, 95123
ItalySite Not Available
Investigational Site Number: 3800001
Milano, 20122
ItalyActive - Recruiting
Investigational Site Number : 5280002
Breda, 4818 CK
NetherlandsSite Not Available
Investigational Site Number : 5280001
Groningen, 9713 GZ
NetherlandsSite Not Available
Investigational Site Number : 5280003
Rotterdam, 3015 GD
NetherlandsSite Not Available
Investigational Site Number : 6160001
Warszawa, Mazowieckie 02-507
PolandSite Not Available
Investigational Site Number : 6160004
Lodz, 90265
PolandSite Not Available
Investigational Site Number : 6160002
Wroclaw, 51-685
PolandSite Not Available
Investigational Site Number : 6160003
Wroclaw, 50-566
PolandSite Not Available
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona] 08041
SpainSite Not Available
Investigational Site Number : 7240006
Madrid, Madrid, Comunidad De 28046
SpainSite Not Available
Investigational Site Number : 7240001
Madrid / Madrid, Madrid, Comunidad De 28007
SpainSite Not Available
Investigational Site Number : 7240004
Manises, Valencia 46940
SpainSite Not Available
Investigational Site Number : 7240005
Córdoba, 14004
SpainSite Not Available
Investigational Site Number : 7520001
Alvsjo, 125 44
SwedenSite Not Available
Medical Dermatology Specialists Site Number : 8400007
Phoenix, Arizona 85006
United StatesSite Not Available
Renstar Medical Research Site Number : 8400011
Ocala, Florida 34470
United StatesSite Not Available
ForCare Clinical Research Site Number : 8400006
Tampa, Florida 33613
United StatesSite Not Available
ForCare Clinical Research_Investigational Site Number: 8400006
Tampa, Florida 33613
United StatesActive - Recruiting
Advanced Medical Research PC Site Number : 8400002
Sandy Springs, Georgia 30328
United StatesSite Not Available
Washington University School of Medicine in St. Louis Site Number : 8400009
Saint Louis, Missouri 63110
United StatesSite Not Available
Clinical Partners, LLC Site Number : 8400010
Johnston, Rhode Island 02919
United StatesSite Not Available
Center for Clinical Studies, LTD. LLP Site Number : 8400003
Houston, Texas 77004
United StatesSite Not Available
Center for Clinical Studies, LTD.LLP_Investigational Site Number: 8400003
Houston, Texas 77004
United StatesActive - Recruiting
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