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Tesevatinib

Phase 2

Autosomal Dominant Polycystic Kidney | Small molecule | Nephrology |Sanofi|Last Updated: Feb 6, 2023

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 Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03203642Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKDPHASE2 COMPLETED 80 — — Oct 12, 2017Jan 25, 2022Feb 6, 202319 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12
Baseline (Day 1), Month 12

htTKV was calculated using total kidney volume (in milliliters) obtained from magnetic resonance imaging (MRI) divided by height (in meters). Least square (LS) mean and standard error (SE) were estimated by using analysis of covariance (ANCOVA) model. Change from Baseline in htTKV at Month 12 was reported in this outcome measure.

Change From Baseline in Height Adjusted Total Kidney Volume at Month 18
Baseline (Day 1), Month 18

htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 18 was reported in this outcome measure.

Change From Baseline in Height Adjusted Total Kidney Volume at Month 24
Baseline (Day 1), Month 24

htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 24 was reported in this outcome measure.

Change From Baseline in Height Adjusted Total Kidney Volume at End of Study
Baseline (Day 1), End of study (anytime up to 26 months)

htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at end of study (i.e., up to 26 months) was reported in this outcome measure.

Secondary Endpoints
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From Baseline (Day 1) up to 30 days post last dose of study drug (i.e., up to 26 months)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 18, 24 and End of Study
Baseline (Day 1), Months 12, 18, 24 and at end of study (i.e., anytime up to 26 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TesevatinibEXPERIMENTALParticipants received tesevatinib 50 mg tablet orally once daily (QD) for up to 25.3 months.
PlaceboPLACEBO_COMPARATORParticipants received placebo matched to tesevatinib tablet orally QD for up to 25.3 months.
Interventions
NameTypeDescription
TesevatinibDRUGPharmaceutical form: Tablet; Route of administration: orally
PlaceboDRUGPharmaceutical form: Tablet (identical to tesevatinib); Route of administration: orally
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * ADPKD diagnosis based on Ravine's criteria. * Cysts of at least 1 centimeter. * Estimated glomerular filtration rate greater than or equal to (\>=) 25 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) and less than or equal to (\<=) 90 mL/min/1.73 m\^2, using the ...

Countries:United States
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