A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Start Date
12/29/2025
Completion Date
12/1/2027
Summary
This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa. The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
SAR445399
Placebo
Conditions
Locations
Scottsdale Clinical Trials- Site Number : 8400006
Scottsdale, Arizona 85260
United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
North Hollywood, California 91606
United States
Encore Medical Research of Boynton Beach- Site Number : 8400005
Boynton Beach, Florida 33436
United States
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
Fort Lauderdale, Florida 33308
United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
Fort Myers, Florida 33912
United States
Encore Medical Research - Hollywood- Site Number : 8400004
Hollywood, Florida 33024
United States
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
Miami, Florida 33146
United States
Florida International Research Center- Site Number : 8400002
Miami, Florida 33173
United States
Florida Research Center- Site Number : 8400009
Miami, Florida 33174
United States
Advanced Clinical Research Institute- Site Number : 8400021
Tampa, Florida 33607
United States
Cleaver Medical Group Dermatology- Site Number : 8400008
Cumming, Georgia 30040
United States
First Georgia Physician Group- Site Number : 8400033
Fayetteville, Georgia 30214
United States
Essential Medical Research- Site Number : 8400015
Overland Park, Kansas 66213
United States
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
Louisville, Kentucky 40241
United States
Equity Medical- Site Number : 8400010
New York, New York 10023
United States
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
The Woodlands, Texas 77380
United States
Investigational Site Number : 0320001
Buenos Aires, 1023
Argentina
Investigational Site Number : 0320002
Buenos Aires, 1061
Argentina
Investigational Site Number : 0360001
Sydney, New South Wales 2010
Australia
Investigational Site Number : 0560002
Brussels, 1070
Belgium
Investigational Site Number : 0560001
Ghent, 9000
Belgium
Investigational Site Number : 0560004
Liège, 4000
Belgium
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
Salvador, Estado de Bahia 41820-020
Brazil
Investigational Site Number : 1240014
Toronto, Ontario M2N 3A6
Canada
Investigational Site Number : 1240010
Montreal, Quebec H1Y 3L1
Canada
Investigational Site Number : 1240002
Sherbrooke, Quebec J1G 1X9
Canada
Investigational Site Number : 1240013
Regina, Saskatchewan S4V 1R9
Canada
Investigational Site Number : 1240011
Saskatoon, Saskatchewan S7K 0H6
Canada
Investigational Site Number : 1560001
Beijing, 100730
China
Investigational Site Number : 1560003
Changsha, 410011
China
Investigational Site Number : 1560004
Shanghai, 200040
China
Investigational Site Number : 1560002
Wuhan, 430022
China
Investigational Site Number : 2500005
Lille, 59020
France
Investigational Site Number : 2500006
Lille, 59037
France
Investigational Site Number : 2500002
Nantes, 44093
France
Investigational Site Number : 2500004
Paris, 75010
France
Investigational Site Number : 2500003
Rouen, 76031
France
Investigational Site Number : 2760004
Blankenfelde-Mahlow, 15831
Germany
Investigational Site Number : 2760007
Darmstadt, 64283
Germany
Investigational Site Number : 2760005
Merzig, 66663
Germany
Investigational Site Number : 2760003
Regensburg, 93053
Germany
Investigational Site Number : 2760002
Rostock, 18055
Germany
Investigational Site Number : 3480002
Budapest, 1085
Hungary
Investigational Site Number : 3480005
Gyula, 5700
Hungary
Investigational Site Number : 3480003
Kaposvár, 7400
Hungary
Investigational Site Number : 3480004
Szeged, 6720
Hungary
Investigational Site Number : 3800002
Torette, Ancona 60020
Italy
Investigational Site Number : 3800005
Cona, Ferrara 44124
Italy
Investigational Site Number : 3800003
Milan, Milano 20132
Italy
Investigational Site Number : 3800004
Brescia, 25123
Italy
Investigational Site Number : 3800001
Chieti, 66100
Italy
Investigational Site Number : 3920002
Tokyo, 160-0023
Japan
Investigational Site Number : 3920001
Tokyo, 173-8610
Japan
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona] 08035
Spain
Investigational Site Number : 7240002
Bilbao, Basque Country 48013
Spain
Investigational Site Number : 7240005
Seville, Sevilla 41009
Spain
Investigational Site Number : 7240001
Córdoba, 14004
Spain
Investigational Site Number : 7240004
Málaga, 29016
Spain
Investigational Site Number : 7520001
Örebro, 701 85
Sweden
Investigational Site Number : 7520002
Uppsala, 752 37
Sweden
Investigational Site Number : 7920006
Buca, 35390
Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, 34093
Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, 34899
Turkey (Türkiye)
Investigational Site Number : 7920004
Izmir, 35540
Turkey (Türkiye)
Investigational Site Number : 7920002
Manisa, 45030
Turkey (Türkiye)
Investigational Site Number : 7920003
Samsun, 55139
Turkey (Türkiye)