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

NCT07225569 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI206742025-522695-83-00U1111-1322-6148
• Study Type: interventional
• Target: 144
• Locations: 13 countries
• Sites: 46

Brief 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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

  Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.

  Up to Week 16

Secondary Outcomes (16)

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

  Up to Week 16

• Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)

  From baseline to Week 16

• Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)

  Up to Week 16

• Percent change from baseline to Week 16 in draining tunnel count

  From Baseline to week 16

• Absolute change from baseline to Week 16 in draining tunnel count

  From Baseline to week 16

Study Arms (3)

SAR445399 dose regimen A

EXPERIMENTAL

Participants will receive SAR445399 dose regimen A.

Drug: SAR445399

SAR445399 dose regimen B

EXPERIMENTAL

Participants will receive SAR445399 dose regimen B.

Drug: SAR445399

Placebo

PLACEBO COMPARATOR

Participants will receive SAR445399-matching placebo.

Drug: Placebo

Interventions

SAR445399 DRUG

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

SAR445399 dose regimen A; SAR445399 dose regimen B

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (46)

Scottsdale Clinical Trials- Site Number : 8400006

Scottsdale, Arizona, 85260, United States

RECRUITING

Carbon Health - North Hollywood - NoHo West- Site Number : 8400017

North Hollywood, California, 91606, United States

RECRUITING

Encore Medical Research of Boynton Beach- Site Number : 8400005

Boynton Beach, Florida, 33436, United States

RECRUITING

FXM Clinical Research - Fort Lauderdale- Site Number : 8400013

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007

Fort Myers, Florida, 33912, United States

RECRUITING

Encore Medical Research - Hollywood- Site Number : 8400004

Hollywood, Florida, 33024, United States

RECRUITING

Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014

Miami, Florida, 33146, United States

RECRUITING

Florida International Research Center- Site Number : 8400002

Miami, Florida, 33173, United States

RECRUITING

Florida Research Center- Site Number : 8400009

Miami, Florida, 33174, United States

RECRUITING

Advanced Clinical Research Institute- Site Number : 8400021

Tampa, Florida, 33607, United States

RECRUITING

Cleaver Medical Group Dermatology- Site Number : 8400008

Cumming, Georgia, 30040, United States

RECRUITING

First Georgia Physician Group- Site Number : 8400033

Fayetteville, Georgia, 30214, United States

RECRUITING

Essential Medical Research- Site Number : 8400015

Overland Park, Kansas, 66213, United States

RECRUITING

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

Louisville, Kentucky, 40241, United States

RECRUITING

Equity Medical- Site Number : 8400010

New York, New York, 10023, United States

RECRUITING

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

The Woodlands, Texas, 77380, United States

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1061, Argentina

RECRUITING

Investigational Site Number : 0560002

Brussels, 1070, Belgium

RECRUITING

Investigational Site Number : 0560001

Ghent, 9000, Belgium

RECRUITING

Investigational Site Number : 0560004

Liège, 4000, Belgium

RECRUITING

Investigational Site Number : 1240013

Regina, Saskatchewan, S4V 1R9, Canada

RECRUITING

Investigational Site Number : 1560001

Beijing, 100730, China

RECRUITING

Investigational Site Number : 1560003

Changsha, 410011, China

RECRUITING

Investigational Site Number : 1560002

Wuhan, 430022, China

RECRUITING

Investigational Site Number : 2500005

Lille, 59020, France

RECRUITING

Investigational Site Number : 2500004

Paris, 75010, France

RECRUITING

Investigational Site Number : 2500003

Rouen, 76031, France

RECRUITING

Investigational Site Number : 2760004

Blankenfelde-Mahlow, 15831, Germany

RECRUITING

Investigational Site Number : 2760005

Merzig, 66663, Germany

RECRUITING

Investigational Site Number : 2760003

Regensburg, 93053, Germany

RECRUITING

Investigational Site Number : 3480005

Gyula, 5700, Hungary

RECRUITING

Investigational Site Number : 3480003

Kaposvár, 7400, Hungary

RECRUITING

Investigational Site Number : 3480004

Szeged, 6720, Hungary

RECRUITING

Investigational Site Number : 3800002

Torette, Ancona, 60020, Italy

RECRUITING

Investigational Site Number : 3800005

Cona, Ferrara, 44124, Italy

RECRUITING

Investigational Site Number : 3800004

Brescia, 25123, Italy

RECRUITING

Investigational Site Number : 3800001

Chieti, 66100, Italy

RECRUITING

Investigational Site Number : 3920001

Tokyo, 173-8610, Japan

RECRUITING

Investigational Site Number : 7240006

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240002

Bilbao, Basque Country, 48013, Spain

RECRUITING

Investigational Site Number : 7240005

Seville, Sevilla, 41009, Spain

RECRUITING

Investigational Site Number : 7240001

Córdoba, 14004, Spain

RECRUITING

Investigational Site Number : 7240004

Málaga, 29016, Spain

RECRUITING

Investigational Site Number : 7520001

Örebro, 701 85, Sweden

RECRUITING

Investigational Site Number : 7520002

Uppsala, 752 37, Sweden

RECRUITING

Investigational Site Number : 7920005

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Related Links

• DRI20674 Plain Language Results Summary

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: \[Specify Complex Masking\]
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): September 22, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1); US (16); HU (3); SE (2); ES (5); CN (3); CA (1); DE (3); BE (3); FR (3); IT (4); AR (1); JP (1)