A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Phase 2 – studying effectiveness and dosage
Conditions:
Hidradenitis Suppurativa
Sponsor: Sanofi
trial.available_in:
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Overview
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 30 weeks with a total of 12 visits. The treatment duration will be 16 weeks.
Who can participate
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months 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 inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
* Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
* Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
* Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
* History of recurrent or recent serious infection
* Known history of or suspected current immunosuppression
* History of solid organ transplant or stem cell transplant.
* History of splenectomy
* History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.
* Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Interventions
SAR445399
DRUG
Placebo
DRUG
Locations
43
Argentina (1)
Investigational Site Number : 0320002
Buenos Aires
Belgium (2)
Investigational Site Number : 0560002
Brussels
Investigational Site Number : 0560001
Ghent
Canada (1)
Investigational Site Number : 1240013
Regina , Saskatchewan
China (3)
Investigational Site Number : 1560001
Beijing
Investigational Site Number : 1560003
Changsha
Investigational Site Number : 1560002
Wuhan
France (3)
Investigational Site Number : 2500005
Lille
Investigational Site Number : 2500004
Paris
Investigational Site Number : 2500003
Rouen
Germany (3)
Investigational Site Number : 2760004
Blankenfelde-Mahlow
Investigational Site Number : 2760005
Merzig
Investigational Site Number : 2760003
Regensburg
Hungary (3)
Investigational Site Number : 3480005
Gyula
Investigational Site Number : 3480003
Kaposvár
Investigational Site Number : 3480004
Szeged
Italy (3)
Investigational Site Number : 3800001
Chieti
Investigational Site Number : 3800005
Cona , Ferrara
Investigational Site Number : 3800002
Torette , Ancona
Japan (1)
Investigational Site Number : 3920001
Tokyo
Spain (5)
Investigational Site Number : 7240006
Barcelona , Barcelona [Barcelona]
Investigational Site Number : 7240002
Bilbao , Basque Country
Investigational Site Number : 7240001
Córdoba
Investigational Site Number : 7240004
Málaga
Investigational Site Number : 7240005
Seville , Sevilla
Sweden (2)
Investigational Site Number : 7520001
Örebro
Investigational Site Number : 7520002
Uppsala
United States (16)
Encore Medical Research of Boynton Beach- Site Number : 8400005
Boynton Beach , Florida
Cleaver Medical Group Dermatology- Site Number : 8400008
Cumming , Georgia
First Georgia Physician Group- Site Number : 8400033
Fayetteville , Georgia
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
Fort Lauderdale , Florida
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
Fort Myers , Florida
Encore Medical Research - Hollywood- Site Number : 8400004
Hollywood , Florida
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
Louisville , Kentucky
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
Miami , Florida
Florida International Research Center- Site Number : 8400002
Miami , Florida
Florida Research Center- Site Number : 8400009
Miami , Florida
Equity Medical- Site Number : 8400010
New York , New York
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
North Hollywood , California
Essential Medical Research- Site Number : 8400015
Overland Park , Kansas
Scottsdale Clinical Trials- Site Number : 8400006
Scottsdale , Arizona
Advanced Clinical Research Institute- Site Number : 8400021
Tampa , Florida
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020