A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA).

Official Title
-----------------
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Drug: Setipiprant
* Drug: Placebo
* Drug: Finasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
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 AGA Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft Use of products within 6 months of study start used continuously for at least 1 month that could impact hair growth Hair-weaving within 6 months Use of hair colorants or dyes within 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Setipiprant<br>Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks. | Drug: Setipiprant<br>* Setipiprant tablets, orally, BID for 24 weeks.<br>* Other names: AGN-241679;|
| Placebo Comparator: Placebo<br>Two placebo tablets BID at 12-hour intervals for 24 weeks. | Drug: Placebo<br>* Placebo tablets, orally, BID for 24 weeks.<br>|
| Active Comparator: Finasteride<br>Finasteride 1 mg tablet, orally, once daily for 24 weeks. | Drug: Finasteride<br>* Finasteride tablet, orally, once daily for 24 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Target Area Hair Count (TAHC) at 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. | Baseline (Day 1) to Week 24 | 
| Subject Self-Assessment (SSA) Score in Hair Growth at 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. | Week 24 |