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Setipiprant

Phase 2

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

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

Clinical trial landscape

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 an investigational small molecule being studied for the treatment of androgenetic alopecia, a common form of hair loss, in males. It is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Setipiprant target?

Setipiprant is a small molecule that acts as a selective antagonist of the prostaglandin D2 receptor, known as DP2 or CRTH2. By blocking this receptor, it is thought to counteract the inhibitory effects of prostaglandin D2 on hair growth.

Who is developing Setipiprant?

Setipiprant is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 2 clinical trials for androgenetic alopecia.

What phase is Setipiprant in?

Setipiprant is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still undergoing clinical trials to evaluate its safety and efficacy for treating androgenetic alopecia in males.

What clinical trials is Setipiprant in?

Setipiprant has been studied in a Phase 2 clinical trial with the identifier NCT02781311. This was a randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of Setipiprant tablets in males with androgenetic alopecia. The trial was conducted in the United States and has been completed.

Is Setipiprant the same as any other drug?

Setipiprant is a distinct investigational compound and is not known to be the same as any other marketed drug. It is being studied specifically for its potential role in treating androgenetic alopecia, and no alternative names have been reported for this asset.