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Setipiprant

Phase 2

Alopecia | Small molecule | Other |AbbVie Inc.|Last Updated: Apr 5, 2019

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_CONTROLLED
Total Trials1
Total Enrollment169
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02781311A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in MalesPHASE2 COMPLETED 169Jul 14, 2016May 22, 2018Apr 5, 201918 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Target Area Hair Count (TAHC) at Week 24
Baseline (Day 1) to Week 24

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters square (cm\^2). TAHC is a standardized objective quantification of the number of hairs within a prespecified target area of the scalp at different timepoints, using macrophotography digital images. The total number of terminal hairs (hair width ≥ 30 μm) was calculated from macrophotographs. The target area used to count TAHC was a 1 cm\^2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a semi-permanent microdot tattoo to ensure the same target area was reproduced at each visit. A positive change from Baseline indicated improvement (increase in the number of terminal hairs). Missing data are imputed up to Week 24 using last observation carried forward (LOCF) method.

Subject Self-Assessment (SSA) Score in Hair Growth at Week 24
Week 24

The SSA consisted of a single-item measure that assesses each participant's perception of change in scalp hair growth. The participant used a standardized global photograph of his scalp taken at the Screening visit presented side by side with a standardized global photograph taken at the postbaseline visit to give a comparative score. The photographs were presented in a blinded and randomized manner to avoid influencing the participant, and response options were on a 7-point ordinal scale (where, -3=Greatly decreased, -2=Moderately decreased, -1=Slightly decreased, 0=No change, +1=Slightly increased, +2=Moderately increased and +3=Greatly increased). The higher the mean SSA value, the more the perception of hair growth from baseline. Missing data are imputed up to Week 24 using LOCF method.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SetipiprantEXPERIMENTALSetipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
PlaceboPLACEBO_COMPARATORTwo placebo tablets BID at 12-hour intervals for 24 weeks.
FinasterideACTIVE_COMPARATORFinasteride 1 mg tablet, orally, once daily for 24 weeks.
Interventions
NameTypeDescription
SetipiprantDRUGSetipiprant tablets, orally, BID for 24 weeks.
PlaceboDRUGPlacebo tablets, orally, BID for 24 weeks.
FinasterideDRUGFinasteride tablet, orally, once daily for 24 weeks.
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Eligibility Criteria
Age Range18 Years — 49 Years
SexMALE
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Participant has androgenetic alopecia (AGA) * Participant agrees to maintain current hair care regimen, refraining from hair weaving, hair colorants or dyes and non-study hair growth products during the study. Exclusion Criteria: * History of hair loss for reasons other than...

Countries:United States
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