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

Purpose

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.

Condition

  • Hidradenitis Suppurativa

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
[Specify Complex Masking]

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SAR445399 dose regimen A
Participants will receive SAR445399 dose regimen A.
  • Drug: SAR445399
    Pharmaceutical form: Solution for injection -Route of administration: Injection
Experimental
SAR445399 dose regimen B
Participants will receive SAR445399 dose regimen B.
  • Drug: SAR445399
    Pharmaceutical form: Solution for injection -Route of administration: Injection
Placebo Comparator
Placebo
Participants will receive SAR445399-matching placebo.
  • Drug: Placebo
    Pharmaceutical form: Solution for injection -Route of administration: Injection

Recruiting Locations

Scottsdale Clinical Trials- Site Number : 8400006
Scottsdale, Arizona 85260

Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
North Hollywood, California 91606

Encore Medical Research of Boynton Beach- Site Number : 8400005
Boynton Beach, Florida 33436

FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
Fort Lauderdale, Florida 33308

Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
Fort Myers, Florida 33912

Encore Medical Research - Hollywood- Site Number : 8400004
Hollywood, Florida 33024

Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
Miami, Florida 33146

Florida International Research Center- Site Number : 8400002
Miami, Florida 33173

Florida Research Center- Site Number : 8400009
Miami, Florida 33174

Advanced Clinical Research Institute- Site Number : 8400021
Tampa, Florida 33607

Cleaver Medical Group Dermatology- Site Number : 8400008
Cumming, Georgia 30040

First Georgia Physician Group- Site Number : 8400033
Fayetteville, Georgia 30214

Essential Medical Research- Site Number : 8400015
Overland Park, Kansas 66213

Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
Louisville, Kentucky 40241

Equity Medical- Site Number : 8400010
New York, New York 10023

Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
The Woodlands, Texas 77380

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com