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

Primary Purpose

Alopecia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Setipiprant
Placebo
Finasteride
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia

Eligibility Criteria

18 Years - 49 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Burke Pharmaceutical Research
  • Petrus Center for Aesthetic Surgery & Hair Transplantation
  • Therapeutics Clinical Research
  • Radiant Research, Inc.
  • DeNova Research
  • Heartland Research Associates, LLC
  • Michigan Center for Skin Care Research
  • Minnesota Clinical Study Center
  • University of Minnesota Department of Dermatology Division of Clinical research
  • Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard
  • Cleveland Clinic, Dept of Dermatology
  • NW Dermatology and Research Center
  • Oregon Medical Research Center
  • Penn State Hershey Medical Center Dermatology Research Office
  • Radiant Research, Inc.
  • DermResearch, Inc
  • Suzzane Bruce and Associates P.A., The Center for Skin Research
  • The Education & Research Foundation, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Setipiprant

Placebo

Finasteride

Arm Description

Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.

Two placebo tablets BID at 12-hour intervals for 24 weeks.

Finasteride 1 mg tablet, orally, once daily for 24 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2016
Last Updated
March 15, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02781311
Brief Title
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Official Title
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2A Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 14, 2016 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
May 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Setipiprant
Arm Type
Experimental
Arm Description
Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two placebo tablets BID at 12-hour intervals for 24 weeks.
Arm Title
Finasteride
Arm Type
Active Comparator
Arm Description
Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Setipiprant
Other Intervention Name(s)
KYTH-105, AGN-241679
Intervention Description
Setipiprant tablets, orally, BID for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets, orally, BID for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Finasteride
Intervention Description
Finasteride tablet, orally, once daily for 24 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Target Area Hair Count (TAHC) at Week 24
Description
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.
Time Frame
Baseline (Day 1) to Week 24
Title
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24
Description
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.
Time Frame
Week 24

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Androgenetic Alopecia in Males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan-En Lin
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Petrus Center for Aesthetic Surgery & Hair Transplantation
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Radiant Research, Inc.
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
University of Minnesota Department of Dermatology Division of Clinical research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic, Dept of Dermatology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
NW Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Penn State Hershey Medical Center Dermatology Research Office
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Radiant Research, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
DermResearch, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Suzzane Bruce and Associates P.A., The Center for Skin Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
The Education & Research Foundation, Inc
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

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

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