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

May 22, 2026 updated by: Sanofi

A Randomized, Double-blind, Placebo-controlled, Phase 2, Dose-finding Study to Investigate the Efficacy and Safety of SAR445399 in Participants With Moderate to Severe Hidradenitis Suppurativa

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1061
        • Recruiting
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1023
        • Recruiting
        • Investigational Site Number : 0320001
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • Investigational Site Number : 0360001
  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • Investigational Site Number : 0560002
      • Ghent, Belgium, 9000
        • Recruiting
        • Investigational Site Number : 0560001
      • Liège, Belgium, 4000
        • Recruiting
        • Investigational Site Number : 0560004
  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4V 1R9
        • Recruiting
        • Investigational Site Number : 1240013
  • China
      • Beijing, China, 100730
        • Recruiting
        • Investigational Site Number : 1560001
      • Changsha, China, 410011
        • Recruiting
        • Investigational Site Number : 1560003
      • Shanghai, China, 200040
        • Recruiting
        • Investigational Site Number : 1560004
      • Wuhan, China, 430022
        • Recruiting
        • Investigational Site Number : 1560002
  • France
      • Lille, France, 59020
        • Recruiting
        • Investigational Site Number : 2500005
      • Lille, France, 59037
        • Recruiting
        • Investigational Site Number : 2500006
      • Nantes, France, 44093
        • Recruiting
        • Investigational Site Number : 2500002
      • Paris, France, 75010
        • Recruiting
        • Investigational Site Number : 2500004
      • Rouen, France, 76031
        • Recruiting
        • Investigational Site Number : 2500003
  • Germany
      • Blankenfelde-Mahlow, Germany, 15831
        • Recruiting
        • Investigational Site Number : 2760004
      • Darmstadt, Germany, 64283
        • Recruiting
        • Investigational Site Number : 2760007
      • Merzig, Germany, 66663
        • Recruiting
        • Investigational Site Number : 2760005
      • Regensburg, Germany, 93053
        • Recruiting
        • Investigational Site Number : 2760003
      • Rostock, Germany, 18055
        • Recruiting
        • Investigational Site Number : 2760002
  • Hungary
      • Gyula, Hungary, 5700
        • Recruiting
        • Investigational Site Number : 3480005
      • Kaposvár, Hungary, 7400
        • Recruiting
        • Investigational Site Number : 3480003
      • Szeged, Hungary, 6720
        • Recruiting
        • Investigational Site Number : 3480004
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Investigational Site Number : 3800004
      • Chieti, Italy, 66100
        • Recruiting
        • Investigational Site Number : 3800001
    • Ancona
      • Torette, Ancona, Italy, 60020
        • Recruiting
        • Investigational Site Number : 3800002
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Recruiting
        • Investigational Site Number : 3800005
  • Japan
      • Tokyo, Japan, 173-8610
        • Recruiting
        • Investigational Site Number : 3920001
      • Tokyo, Japan, 160-0023
        • Recruiting
        • Investigational Site Number : 3920002
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Investigational Site Number : 7240001
      • Málaga, Spain, 29016
        • Recruiting
        • Investigational Site Number : 7240004
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Investigational Site Number : 7240006
    • Basque Country
      • Bilbao, Basque Country, Spain, 48013
        • Recruiting
        • Investigational Site Number : 7240002
    • Sevilla
      • Seville, Sevilla, Spain, 41009
        • Recruiting
        • Investigational Site Number : 7240005
  • Sweden
      • Uppsala, Sweden, 752 37
        • Recruiting
        • Investigational Site Number : 7520002
      • Örebro, Sweden, 701 85
        • Recruiting
        • Investigational Site Number : 7520001
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34093
        • Recruiting
        • Investigational Site Number : 7920001
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Investigational Site Number : 7920005
      • Izmir, Turkey (Türkiye), 35540
        • Recruiting
        • Investigational Site Number : 7920004
      • Manisa, Turkey (Türkiye), 45030
        • Recruiting
        • Investigational Site Number : 7920002
      • Samsun, Turkey (Türkiye), 55139
        • Recruiting
        • Investigational Site Number : 7920003
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Scottsdale Clinical Trials- Site Number : 8400006
    • California
      • North Hollywood, California, United States, 91606
        • Recruiting
        • Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
    • Florida
      • Boynton Beach, Florida, United States, 33436
        • Recruiting
        • Encore Medical Research of Boynton Beach- Site Number : 8400005
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Encore Medical Research - Hollywood- Site Number : 8400004
      • Miami, Florida, United States, 33173
        • Recruiting
        • Florida International Research Center- Site Number : 8400002
      • Miami, Florida, United States, 33146
        • Recruiting
        • Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
      • Miami, Florida, United States, 33174
        • Recruiting
        • Florida Research Center- Site Number : 8400009
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Advanced Clinical Research Institute- Site Number : 8400021
    • Georgia
      • Cumming, Georgia, United States, 30040
        • Recruiting
        • Cleaver Medical Group Dermatology- Site Number : 8400008
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • First Georgia Physician Group- Site Number : 8400033
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Recruiting
        • Essential Medical Research- Site Number : 8400015
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
    • New York
      • New York, New York, United States, 10023
        • Recruiting
        • Equity Medical- Site Number : 8400010
    • Texas
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Time Frame: Up to Week 16
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time Frame: Up to Week 16
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count)
Up to Week 16
Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
Time Frame: From baseline to Week 16
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
From baseline to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Time Frame: Up to Week 16
Hidradenitis Suppurativa Clinical Response 90 is defined as ≥90% 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
Percent change from baseline to Week 16 in draining tunnel count
Time Frame: From Baseline to week 16
From Baseline to week 16
Absolute change from baseline to Week 16 in draining tunnel count
Time Frame: From Baseline to week 16
From Baseline to week 16
Percent change from baseline to Week 16 in Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS)
Time Frame: From Baseline to Week 16
From Baseline to Week 16
Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
Time Frame: From Baseline to Week 16
The Hidradenitis Suppurativa Quality of Life (HiSQoL) is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
From Baseline to Week 16
Change from baseline to Week 16 in Weekly average HS-SAQ score items
Time Frame: From Baseline to Week 16
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. Each item is scored on a 0 to 10 scale with 0 indicating "no symptom" and 10 indicating "worst symptom possible".
From Baseline to Week 16
Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
Time Frame: From Baseline to Week 16
The Peak Pruritus Numerical Rating Scale (PP-NRS) is defined as achieving at least 4-unit reduction from Baseline in weekly average of daily PP-NRS among participants with baseline PP-NRS ≥4)
From Baseline to Week 16
Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average HS-Skin Pain NRS item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3
Time Frame: From baseline to Week 16
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period).
From baseline to Week 16
Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
Time Frame: From Baseline to Week 16
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
From Baseline to Week 16
Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score
Time Frame: From Baseline to Week 16
The Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) is an 11-item questionnaire assessing the impact of HS on QoL
From Baseline to Week 16
Number of participants with TEAEs AESIs, and SAEs including administration site reactions during the double-blinded initial treatment period and the treatment-blinded extension period
Time Frame: Up to End of Study (approximately 46 weeks)
Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs).
Up to End of Study (approximately 46 weeks)
Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs) during the double- blinded initial treatment period and the treatment-blinded extension period
Time Frame: Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Plasma concentrations of SAR445399 during the double-blinded initial treatment period and the treatment-blinded extension period
Time Frame: Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints during the double-blinded initial treatment period and the treatment-blinded extension period
Time Frame: Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

September 22, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI20674
  • 2025-522695-83-00 (Registry Identifier: CTIS)
  • U1111-1322-6148 (Other Identifier: WHO-ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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