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

• ClinicalTrials.gov Identifier: NCT02781311
• Recruitment Status: Completed
• First Posted: May 24, 2016
• Results First Posted: April 5, 2019
• Last Update Posted: April 5, 2019
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: May 20, 2016
• First Posted Date: May 24, 2016
• Results First Submitted Date: March 15, 2019
• Results First Posted Date: April 5, 2019
• Last Update Posted Date: April 5, 2019
• Actual Study Start Date: July 14, 2016
• Actual Primary Completion Date: March 15, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2019)

• Change From Baseline in Target Area Hair Count (TAHC) at Week 24 [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: May 20, 2016)

• Change from Baseline in Target Area Hair Count (TAHC) within a 1 cm^2 Circular Area [ Time Frame: Baseline, Week 24 ]
• Subject Self-Assessment (SSA) of the Change in Scalp Hair Growth using a 7-Point Scale [ Time Frame: Baseline, Week 24 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alopecia

Intervention

• Drug: Setipiprant
  Setipiprant tablets, orally, BID for 24 weeks.
  Other Names:

  • KYTH-105
  • AGN-241679
• Drug: Placebo
  Placebo tablets, orally, BID for 24 weeks.
• Drug: Finasteride
  Finasteride tablet, orally, once daily for 24 weeks.

Study Arms

• Experimental: Setipiprant
  Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
  Intervention: Drug: Setipiprant
• Placebo Comparator: Placebo
  Two placebo tablets BID at 12-hour intervals for 24 weeks.
  Intervention: Drug: Placebo
• Active Comparator: Finasteride
  Finasteride 1 mg tablet, orally, once daily for 24 weeks.
  Intervention: Drug: Finasteride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 16, 2017): 169
• Original Estimated Enrollment (submitted: May 20, 2016): 187
• Actual Study Completion Date: May 22, 2018
• Actual Primary Completion Date: March 15, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Androgenetic Alopecia in Males

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02781311
• Other Study ID Numbers: 1922-201-002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Allergan
• Study Sponsor: Allergan
• Collaborators: Not Provided

Investigators

• Study Director: Joan-En Lin; Allergan

• PRS Account: Allergan
• Verification Date: March 2019