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Clinical Trials in China / NCT07225569
Recruiting Phase 2

A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

NCT07225569 · tracked via the Priya Life Science China tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2025-12-29
Last updated
2026-09-03

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

SAR445399Placebo

SAR445399: Pharmaceutical form: Solution for injection -Route of administration: Injection

Placebo: Pharmaceutical form: Solution for injection -Route of administration: Injection

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (67)

FacilityCityRegionStatus
Scottsdale Clinical Trials- Site Number : 8400006 Scottsdale Arizona Recruiting
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017 North Hollywood California Recruiting
Encore Medical Research of Boynton Beach- Site Number : 8400005 Boynton Beach Florida Recruiting
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013 Fort Lauderdale Florida Recruiting
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007 Fort Myers Florida Recruiting
Encore Medical Research - Hollywood- Site Number : 8400004 Hollywood Florida Recruiting
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014 Miami Florida Recruiting
Florida International Research Center- Site Number : 8400002 Miami Florida Recruiting
Florida Research Center- Site Number : 8400009 Miami Florida Recruiting
Advanced Clinical Research Institute- Site Number : 8400021 Tampa Florida Recruiting
Cleaver Medical Group Dermatology- Site Number : 8400008 Cumming Georgia Recruiting
First Georgia Physician Group- Site Number : 8400033 Fayetteville Georgia Recruiting
Essential Medical Research- Site Number : 8400015 Overland Park Kansas Recruiting
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026 Louisville Kentucky Recruiting
Equity Medical- Site Number : 8400010 New York New York Recruiting
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020 The Woodlands Texas Recruiting
Investigational Site Number : 0320001 Buenos Aires Argentina Recruiting
Investigational Site Number : 0320002 Buenos Aires Argentina Recruiting
Investigational Site Number : 0360001 Sydney New South Wales Recruiting
Investigational Site Number : 0560002 Brussels Belgium Recruiting
Investigational Site Number : 0560001 Ghent Belgium Recruiting
Investigational Site Number : 0560004 Liège Belgium Recruiting
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001 Salvador Estado de Bahia Recruiting
Investigational Site Number : 1240014 Toronto Ontario Recruiting
Investigational Site Number : 1240010 Montreal Quebec Recruiting
Investigational Site Number : 1240002 Sherbrooke Quebec Recruiting
Investigational Site Number : 1240013 Regina Saskatchewan Recruiting
Investigational Site Number : 1240011 Saskatoon Saskatchewan Recruiting
Investigational Site Number : 1560001 Beijing China Recruiting
Investigational Site Number : 1560003 Changsha China Recruiting
Investigational Site Number : 1560004 Shanghai China Recruiting
Investigational Site Number : 1560002 Wuhan China Recruiting
Investigational Site Number : 2500005 Lille France Recruiting
Investigational Site Number : 2500006 Lille France Recruiting
Investigational Site Number : 2500002 Nantes France Recruiting
Investigational Site Number : 2500004 Paris France Recruiting
Investigational Site Number : 2500003 Rouen France Recruiting
Investigational Site Number : 2760004 Blankenfelde-Mahlow Germany Recruiting
Investigational Site Number : 2760007 Darmstadt Germany Recruiting
Investigational Site Number : 2760005 Merzig Germany Recruiting

+ 27 more sites — see the full list on the official registry below.

More Sanofi trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07225569 on ClinicalTrials.gov ↗ ← All trials in China