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Setipiprant

Phase 2

Alopecia | Small molecule | Dermatology |AbbVie Inc.|Trials Updated: Apr 5, 2019

Setipiprant development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2016

Setipiprant target and mechanism

Molecular targetPTGDR2
Target classAntagonist
ModalitySmall molecule

Also known as KYTH-105, AGN-241679

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment169

FDA Designations

No designations recorded

Setipiprant clinical trials

Setipiprant · 1 trial · 1 indication

Phase 2 1
NCT02781311A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in MalesAlopecia
COMPLETED169 Analytics
PHASE2COMPLETED
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
AlopeciaUnlock trial analytics

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 to 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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Frequently asked questions about Setipiprant

What is Setipiprant used for?

Setipiprant is being studied for the treatment of androgenetic alopecia, a form of hair loss. It is an investigational oral small molecule developed by AbbVie Inc. and has been evaluated in a Phase 2 clinical trial in males with this condition. It is not approved for any indication.

What does Setipiprant target?

Setipiprant targets PTGDR2, also known as the DP2 receptor, where it acts as an antagonist. By blocking this receptor, the drug is designed to interfere with a pathway thought to contribute to hair follicle miniaturization in androgenetic alopecia.

Who is developing Setipiprant?

Setipiprant is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. The company sponsored the Phase 2 clinical trial of the drug in androgenetic alopecia.

What phase is Setipiprant in?

Setipiprant is in Phase 2 development. It has completed one Phase 2 clinical trial in androgenetic alopecia and is not currently approved by the FDA for any indication. No active trials are ongoing.

What clinical trials is Setipiprant in?

Setipiprant has been evaluated in one completed Phase 2 trial, NCT02781311, titled A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males. The trial enrolled 169 male participants aged 18 years and older in the United States and was randomized, double-blind, and placebo-controlled.