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SAR445399

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Sanofi|Last Updated: May 26, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment144
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07225569A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis SuppurativaPHASE2 RECRUITING 144Dec 29, 2025Dec 1, 2027May 26, 202658 United States, Argentina +12
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Study Endpoints
Primary Endpoints
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
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.

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR445399 dose regimen AEXPERIMENTALParticipants will receive SAR445399 dose regimen A.
SAR445399 dose regimen BEXPERIMENTALParticipants will receive SAR445399 dose regimen B.
PlaceboPLACEBO_COMPARATORParticipants will receive SAR445399-matching placebo.
Interventions
NameTypeDescription
SAR445399DRUGPharmaceutical form: Solution for injection -Route of administration: Injection
PlaceboDRUGPharmaceutical form: Solution for injection -Route of administration: Injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites58

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 prese...

Countries:United StatesArgentinaAustraliaBelgiumCanadaChinaFranceGermanyHungaryItalyJapanSpainSwedenTurkey (Türkiye)
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07225569lastUpdatePostDate: changed
LOWMay 27, 2026NCT07225569lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07225569primaryCompletionDate: changed
LOWMay 24, 2026NCT07225569studyFirstPostDate: changed