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A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Led by Sanofi · Updated on 2026-05-04
144
Participants Needed
46
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of hidradenitis suppurativa symptoms for at least 6 months before baseline
- Hidradenitis suppurativa lesions in at least 2 different body areas, with at least one site at Hurley Stage II or III
- Total abscess and inflammatory nodule count of 5 or more at baseline
- Inadequate response, recurrence, intolerance, or contraindication to oral antibiotics for hidradenitis suppurativa
- For biologic-na�efve group: no prior biologic therapy affecting hidradenitis suppurativa
- For biologic-experienced group: documented use of at least one dose of biologic therapy for hidradenitis suppurativa
You will not qualify if you...
- Any other active skin disease or infection that could affect hidradenitis suppurativa assessment
- History of recurrent or recent serious infection
- Known or suspected immunosuppression
- History of solid organ or stem cell transplant
- History of splenectomy
- History of malignancy or lymphoproliferative disease except certain treated skin cancers
- Any severe medical condition, psychiatric illness, or substance abuse that poses risk or interferes with study or reliability
AI-Screening
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Trial Site Locations
Total: 46 locations
1
Scottsdale Clinical Trials- Site Number : 8400006
Scottsdale, Arizona, United States, 85260
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2
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
North Hollywood, California, United States, 91606
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3
Encore Medical Research of Boynton Beach- Site Number : 8400005
Boynton Beach, Florida, United States, 33436
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4
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
Fort Lauderdale, Florida, United States, 33308
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5
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
Fort Myers, Florida, United States, 33912
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6
Encore Medical Research - Hollywood- Site Number : 8400004
Hollywood, Florida, United States, 33024
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7
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
Miami, Florida, United States, 33146
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8
Florida International Research Center- Site Number : 8400002
Miami, Florida, United States, 33173
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9
Florida Research Center- Site Number : 8400009
Miami, Florida, United States, 33174
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10
Advanced Clinical Research Institute- Site Number : 8400021
Tampa, Florida, United States, 33607
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11
Cleaver Medical Group Dermatology- Site Number : 8400008
Cumming, Georgia, United States, 30040
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12
First Georgia Physician Group- Site Number : 8400033
Fayetteville, Georgia, United States, 30214
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13
Essential Medical Research- Site Number : 8400015
Overland Park, Kansas, United States, 66213
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14
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
Louisville, Kentucky, United States, 40241
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15
Equity Medical- Site Number : 8400010
New York, New York, United States, 10023
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16
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
The Woodlands, Texas, United States, 77380
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17
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1061
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18
Investigational Site Number : 0560002
Brussels, Belgium, 1070
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19
Investigational Site Number : 0560001
Ghent, Belgium, 9000
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20
Investigational Site Number : 0560004
Liège, Belgium, 4000
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21
Investigational Site Number : 1240013
Regina, Saskatchewan, Canada, S4V 1R9
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22
Investigational Site Number : 1560001
Beijing, China, 100730
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23
Investigational Site Number : 1560003
Changsha, China, 410011
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24
Investigational Site Number : 1560002
Wuhan, China, 430022
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25
Investigational Site Number : 2500005
Lille, France, 59020
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26
Investigational Site Number : 2500004
Paris, France, 75010
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27
Investigational Site Number : 2500003
Rouen, France, 76031
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28
Investigational Site Number : 2760004
Blankenfelde-Mahlow, Germany, 15831
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29
Investigational Site Number : 2760005
Merzig, Germany, 66663
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30
Investigational Site Number : 2760003
Regensburg, Germany, 93053
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31
Investigational Site Number : 3480005
Gyula, Hungary, 5700
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32
Investigational Site Number : 3480003
Kaposvár, Hungary, 7400
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33
Investigational Site Number : 3480004
Szeged, Hungary, 6720
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34
Investigational Site Number : 3800002
Torette, Ancona, Italy, 60020
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35
Investigational Site Number : 3800005
Cona, Ferrara, Italy, 44124
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36
Investigational Site Number : 3800004
Brescia, Italy, 25123
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37
Investigational Site Number : 3800001
Chieti, Italy, 66100
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38
Investigational Site Number : 3920001
Tokyo, Japan, 173-8610
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39
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], Spain, 08035
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40
Investigational Site Number : 7240002
Bilbao, Basque Country, Spain, 48013
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41
Investigational Site Number : 7240005
Seville, Sevilla, Spain, 41009
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42
Investigational Site Number : 7240001
Córdoba, Spain, 14004
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43
Investigational Site Number : 7240004
Málaga, Spain, 29016
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44
Investigational Site Number : 7520001
Örebro, Sweden, 701 85
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45
Investigational Site Number : 7520002
Uppsala, Sweden, 752 37
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46
Investigational Site Number : 7920005
Istanbul, Turkey (Türkiye), 34899
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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