A Phase 2 interventional study of SAR445399 and Placebo in Hidradenitis Suppurativa, sponsored by Sanofi. Recruiting at 86 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Among 161 studies in Hidradenitis Suppurativa with a site in United States — 38 open to participants now, 55 under way, 12 of them phase 3. Hidradenitis Suppurativa · United States.
Among the 161 studies in Hidradenitis Suppurativa with a site in United States, this one is the 52nd largest by planned enrollment of the 139 interventional ones that give a count, is one of 25 that started in 2025, is one of 61 in phase 2, reaches primary completion later than 29 of the 54 other live ones, and was the 144th registered.
285 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
Browse Hidradenitis Suppurativa studies →38 of the 161 studies in Hidradenitis Suppurativa with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18+
Novartis Pharmaceuticals · Sites in United States
Ages 18–65
Corvus Pharmaceuticals, Inc. · Sites in United States
Ages 18+
Harrison Dermatology · Sites in United States
Ages 12+
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 61 Hidradenitis Suppurativa studies recruiting now, 33 (54%) set no upper age limit and 17 (28%) stop at 75 or younger; 13 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
161 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 65 · Phase 3 27 · Phase 4 5
First in 2005; this study’s year is marked. 25 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 144 is above the median of 45 across 200 interventional studies indexed under Hidradenitis Suppurativa.
Median enrollment 45 across the 139 interventional studies, 300 across the 22 observational. Of the 95 that completed or were terminated, 52 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
87 of 161 have an industry lead sponsor. The 10 most frequent:
Sanofi is the lead sponsor of 1,558 studies on the registry; 90 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Sanofi has 4 studies filed under Hidradenitis Suppurativa — fewer than ten, so there is no comparison to draw.
21 of the studies in Hidradenitis Suppurativa with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06468228Phase 3AbbVieA Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa | 2026-12 |
| NCT06921850Phase 3UCB Biopharma SRLA Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa | 2026-12-21 |
| NCT06212999Phase 3Incyte CorporationA Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa | 2026-12-26 |
| NCT06799000Phase 3Novartis PharmaceuticalsA Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1) | 2027-05-17 |
| NCT06840392Phase 3Novartis PharmaceuticalsA Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa | 2027-06-03 |
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Among the 161 studies in Hidradenitis Suppurativa with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive SAR445399 dose regimen A.
Drug: SAR445399
Participants will receive SAR445399 dose regimen B.
Drug: SAR445399
Participants will receive SAR445399-matching placebo.
Drug: Placebo
Pharmaceutical form: Solution for injection -Route of administration: Injection
Pharmaceutical form: Solution for injection -Route of administration: Injection
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.
Time frame: Up to Week 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)
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 16
Percent change from baseline to Week 16 in draining tunnel count
Time frame: From Baseline to week 16
Absolute change from baseline to Week 16 in draining tunnel count
Time frame: 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).
Time frame: 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
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.
Time frame: 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.
Time frame: 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".
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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)
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)
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)
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Plan to share: 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
Started Dec 2025 (actual). Primary completion is estimated for Sep 2027, 20 months after the start.
Of 44 industry-sponsored phase 2 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's planned 20 months is above that.
Counting every sponsor, half of 54 studies reached it within 15 months; a quarter within 11 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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