Hidradenitis SuppurativaPhase 2CLAROSNCT07225569
A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing SAR445399 in people with Hidradenitis Suppurativa, run by Sanofi at 86 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- SAR445399
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 86 sitesin 15 countries
- Study dates
- 29 Dec 2025to 19 Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
86 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
86 sites in 15 countries
United States21 sites, 20 recruiting
- Recruiting
Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001
Boston, Massachusetts, 02215
- Recruiting
Encore Medical Research of Boynton Beach- Site Number : 8400005
Boynton Beach, Florida, 33436
- Recruiting
Cleaver Medical Group Dermatology- Site Number : 8400008
Cumming, Georgia, 30040
- Recruiting
Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029
Evansville, Indiana, 47708
- Recruiting
First Georgia Physician Group- Site Number : 8400033
Fayetteville, Georgia, 30214
- Recruiting
FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
Fort Lauderdale, Florida, 33308
- Recruiting
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
Fort Myers, Florida, 33912
- Recruiting
Encore Medical Research - Hollywood- Site Number : 8400004
Hollywood, Florida, 33024
- Recruiting
University Health Dermatology- Site Number : 8400018
Kansas City, Missouri, 64108
- Recruiting
Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
Louisville, Kentucky, 40241
- Recruiting
Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
Miami, Florida, 33146
- Recruiting
Florida International Research Center- Site Number : 8400002
Miami, Florida, 33173
- Recruiting
Florida Research Center- Site Number : 8400009
Miami, Florida, 33174
- Recruiting
Virginia Dermatology & Skin Cancer Center- Site Number : 8400024
Norfolk, Virginia, 23502
- Active, not recruiting
Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
North Hollywood, California, 91606
- Recruiting
Scottsdale Clinical Trials- Site Number : 8400006
Scottsdale, Arizona, 85260
- Recruiting
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019
Skokie, Illinois, 60077
- Recruiting
Advanced Clinical Research Institute- Site Number : 8400021
Tampa, Florida, 33607
- Recruiting
Equity Medical (LLC)- Site Number : 8400010
The Bronx, New York, 10455
- Recruiting
Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
The Woodlands, Texas, 77380
- Recruiting
Essential Medical Research- Site Number : 8400015
Tulsa, Oklahoma, 74137
Canada8 sites, 8 recruiting
- Recruiting
Investigational Site Number : 1240015
Mississauga, Ontario, L4W 0C2
- Recruiting
Investigational Site Number : 1240010
Montreal, Quebec, H1Y 3L1
- Recruiting
Investigational Site Number : 1240013
Regina, Saskatchewan, S4V 1R9
- Recruiting
Investigational Site Number : 1240001
Richmond Hill, Ontario, L4B 1L1
- Recruiting
Investigational Site Number : 1240011
Saskatoon, Saskatchewan, S7K 0H6
- Recruiting
Investigational Site Number : 1240002
Sherbrooke, Quebec, J1G 1X9
- Recruiting
Investigational Site Number : 1240014
Toronto, Ontario, M2N 3A6
- Recruiting
Investigational Site Number : 1240016
Winnipeg, Manitoba, R3M 3Z4
Italy7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 3800004
Brescia, 25123
- Recruiting
Investigational Site Number : 3800001
Chieti, 66100
- Recruiting
Investigational Site Number : 3800005
Cona, Ferrara, 44124
- Recruiting
Investigational Site Number : 3800007
Garbagnate Milanese, Milano, 20024
- Recruiting
Investigational Site Number : 3800003
Milan, Milano, 20132
- Recruiting
Investigational Site Number : 3800006
Pisa, 56126
- Recruiting
Investigational Site Number : 3800002
Torette, Ancona, 60020
Germany6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 2760004
Blankenfelde-Mahlow, 15831
- Recruiting
Investigational Site Number : 2760007
Darmstadt, 64283
- Recruiting
Investigational Site Number : 2760006
Dresden, 01307
- Recruiting
Investigational Site Number : 2760005
Merzig, 66663
- Recruiting
Investigational Site Number : 2760003
Regensburg, 93053
- Recruiting
Investigational Site Number : 2760002
Rostock, 18055
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 7920006
Buca, 35390
- Recruiting
Investigational Site Number : 7920001
Istanbul, 34093
- Recruiting
Investigational Site Number : 7920005
Istanbul, 34899
- Recruiting
Investigational Site Number : 7920004
Izmir, 35540
- Recruiting
Investigational Site Number : 7920002
Manisa, 45030
- Recruiting
Investigational Site Number : 7920003
Samsun, 55139
China5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 1560001
Beijing, 100730
- Recruiting
Investigational Site Number : 1560003
Changsha, 410011
- Recruiting
Investigational Site Number : 1560006
Hangzhou, 310009
- Recruiting
Investigational Site Number : 1560004
Shanghai, 200040
- Recruiting
Investigational Site Number : 1560002
Wuhan, 430022
France5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 2500005
Lille, 59020
- Recruiting
Investigational Site Number : 2500006
Lille, 59037
- Recruiting
Investigational Site Number : 2500002
Nantes, 44093
- Recruiting
Investigational Site Number : 2500004
Paris, 75010
- Recruiting
Investigational Site Number : 2500003
Rouen, 76031
Japan5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 3920003
Koshigaya, Saitama, 343-0845
- Recruiting
Investigational Site Number : 3920004
Nagoya, Aichi-ken, 467-8602
- Recruiting
Investigational Site Number : 3920002
Tokyo, 160-0023
- Recruiting
Investigational Site Number : 3920001
Tokyo, 173-8610
- Recruiting
Investigational Site Number : 3920005
Tsukuba, Ibaraki, 305-8576
Spain5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 7240006
Barcelona, Catalunya [Cataluña], 08035
- Recruiting
Investigational Site Number : 7240002
Bilbao, Basque Country, 48013
- Recruiting
Investigational Site Number : 7240001
Córdoba, 14004
- Recruiting
Investigational Site Number : 7240004
Málaga, 29016
- Recruiting
Investigational Site Number : 7240005
Seville, Sevilla, 41009
Hungary4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 3480002
Budapest, 1085
- Recruiting
Investigational Site Number : 3480005
Gyula, 5700
- Recruiting
Investigational Site Number : 3480003
Kaposvár, 7400
- Recruiting
Investigational Site Number : 3480004
Szeged, 6720
Argentina3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1023
- Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1061
- Recruiting
Investigational Site Number : 0320003
Buenos Aires, 1181
Australia3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 0360002
South Perth, Western Australia, 6151
- Recruiting
Investigational Site Number : 0360001
Sydney, New South Wales, 2010
- Recruiting
Investigational Site Number : 0360003
Woodville, South Australia, 5011
Belgium3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 0560002
Brussels, 1070
- Recruiting
Investigational Site Number : 0560001
Ghent, 9000
- Recruiting
Investigational Site Number : 0560004
Liège, 4000
Brazil3 sites, 3 recruiting
- Recruiting
Hospital das Clinicas da UNICAMP- Site Number : 0760002
Campinas, São Paulo, 13083-888
- Recruiting
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
Salvador, Estado de Bahia, 41820-020
- Recruiting
Hospital Israelita Albert Einstein- Site Number : 0760004
São Paulo, 05651-901
Sweden2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7520001
Örebro, 701 85
- Recruiting
Investigational Site Number : 7520002
Uppsala, 752 37
About this study
Official title: 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- SAR445399, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR445399Drug
Pharmaceutical form: Solution for injection -Route of administration: Injection
PlaceboDrug
Pharmaceutical form: Solution for injection -Route of administration: Injection
| Study group | Role | What they receive |
|---|---|---|
| SAR445399 dose regimen A | Experimental | Participants will receive SAR445399 dose regimen A. Receives: Drug: SAR445399 |
| SAR445399 dose regimen B | Experimental | Participants will receive SAR445399 dose regimen B. Receives: Drug: SAR445399 |
| Placebo | Placebo comparator | Participants will receive SAR445399-matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 16
Secondary outcomes (16)
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
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)
Measured: Up to Week 16
Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
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.
Measured: From baseline to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
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.
Measured: Up to Week 16
Percent change from baseline to Week 16 in draining tunnel count
Measured: From Baseline to week 16
Absolute change from baseline to Week 16 in draining tunnel count
Measured: 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
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).
Measured: From baseline to Week 16
Percent change from baseline to Week 16 in Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS)
Measured: From Baseline to Week 16
Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
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.
Measured: From Baseline to Week 16
Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
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.
Measured: From Baseline to Week 16
Change from baseline to Week 16 in Weekly average HS-SAQ score items
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".
Measured: From Baseline to Week 16
Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score
The Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) is an 11-item questionnaire assessing the impact of HS on QoL
Measured: From Baseline to Week 16
Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at 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)
Measured: 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
Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs).
Measured: 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
Measured: 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
Measured: 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
Measured: Up to End of Study (approximately 46 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start29 Dec 2025
- Primary completion22 Sep 2027 (estimated)
- Study completion19 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225569
- Sponsor's protocol ID
- DRI20674
- Other IDs
- 2025-522695-83-00, U1111-1322-6148, 2025
- Acronym
- CLAROS
- Status last verified
- Oct 2026
- First submitted
- 4 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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