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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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