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SAR447971

Phase 1

Hidradenitis | Small molecule | Dermatology |Kymera Therapeutics, Inc.|Last Updated: Jun 5, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07629336SAR447971 First-in-human StudyPHASE1 RECRUITING 114 — — May 26, 2026Feb 16, 2028Jun 5, 20261 Netherlands
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Study Endpoints
Primary Endpoints
SAD20411: Incidence of treatment emergent adverse events (TEAEs)
Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in vital signs
Day 1 to Day 15
SAD20411: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Day 1 to Day 15
MAD20412: Incidence of treatment emergent adverse events (TEAEs)
Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in vital signs
Day 1 to Dat 29
MAD20412: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Day 1 to Dat 29
MAD24339: Incidence of treatment emergent adverse events (TEAEs)
Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis)
Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in vital signs
Day 1 to Day 42
MAD24339: Incidence of clinically significant abnormalities in ECG (heart rate, PR, QRS, QT, QTcF)
Day 1 to Day 42
Secondary Endpoints
SAD20411: PK parameter - Cmax
Day 1 to Day 15
SAD20411: PK parameter - tmax
Day 1 to Day 15
SAD20411:PK parameter - AUC
Day 1 to Day 15
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR447971EXPERIMENTALSingle or multiple doses by mouth as per protocol
PlaceboPLACEBO_COMPARATORSingle or multiple doses by mouth as per protocol
Interventions
NameTypeDescription
SAR447971DRUGPharmaceutical form: Tablet Route of administration: Oral
PlaceboDRUGPharmaceutical form: Tablet Route of administration: Oral
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: For participation in SAD20411/MAD20412: * Male and/or female participant, between 18 and 55 years of age, inclusive at the time of signing the ICF. * Appearing healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). For part...

Countries:Netherlands
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Competitive Landscape -Hidradenitis Suppurativa 41 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Lutikizumab, Upadacitinib
Incyte CorporationINCY6PHASE3Povorcitinib, povorcitinib, Ruxolitinib, Vehicle
Novartis AG Sponsored ADRNVS12PHASE3secukinumab, Remibrutinib Dose A, Remibrutinib Dose B, CFZ533, LYS006
MoonLake Immunotherapeutics Class AMLTX4PHASE3Sonelokimab
Sanofi SA Sponsored ADRSNY2PHASE2Brivekimig, SAR445399
Insmed IncorporatedINSM1PHASE2Brensocatib
Eli Lilly and CompanyLLY1PHASE2Eltrekibart
Pfizer Inc.PFE1PHASE2Ritlecitinib
Merck & Co., Inc.MRK1PHASE2Tulisokibart
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Zasocitinib
Zura Bio Limited Class AZURA1PHASE2Tibulizumab Dose A, Tibulizumab Dose B
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Evommune, Inc.EVMN1EARLY_PHASE1EVO101
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07629336NEW_TRIAL: changed
LOWJun 5, 2026NCT07629336NEW_TRIAL: changed
LOWJun 5, 2026NCT07629336NEW_TRIAL: changed
LOWJun 5, 2026NCT07629336NEW_TRIAL: changed