Trial Outcomes & Findings for A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males (NCT NCT02781311)

Last Updated: 2019-04-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

169 participants

Primary outcome timeframe

Baseline (Day 1) to Week 24

Results posted on

2019-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Two placebo tablets, twice daily (BID) at 12-hour intervals for 24 weeks.	Setipiprant Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.	Finasteride Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Overall Study STARTED	74	83	12
Overall Study Safety Population (Treated)	73	81	12
Overall Study mITT Population	70	78	11
Overall Study COMPLETED	48	57	8
Overall Study NOT COMPLETED	26	26	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Two placebo tablets, twice daily (BID) at 12-hour intervals for 24 weeks.	Setipiprant Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.	Finasteride Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Overall Study Adverse Event	2	6	1
Overall Study Withdrawal of Consent	11	12	2
Overall Study Lost to Follow-up	11	8	1
Overall Study Non-Compliance with Study Drug	2	0	0

Baseline Characteristics

Participants from mITT with data available for analysis at the given timepoint.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=70 Participants Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant n=78 Participants Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.	Finasteride n=11 Participants Finasteride 1 mg tablet, orally, once daily for 24 weeks.	Total n=159 Participants Total of all reporting groups
Age, Continuous	36.9 years STANDARD_DEVIATION 6.08 • n=70 Participants	36.3 years STANDARD_DEVIATION 6.69 • n=78 Participants	34.1 years STANDARD_DEVIATION 3.05 • n=11 Participants	36.4 years STANDARD_DEVIATION 6.25 • n=159 Participants
Sex/Gender, Customized Male	70 Participants n=70 Participants	78 Participants n=78 Participants	11 Participants n=11 Participants	159 Participants n=159 Participants
Race/Ethnicity, Customized White	59 Participants n=70 Participants	70 Participants n=78 Participants	9 Participants n=11 Participants	138 Participants n=159 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=70 Participants	3 Participants n=78 Participants	0 Participants n=11 Participants	7 Participants n=159 Participants
Race/Ethnicity, Customized Asian	4 Participants n=70 Participants	1 Participants n=78 Participants	1 Participants n=11 Participants	6 Participants n=159 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=70 Participants	0 Participants n=78 Participants	1 Participants n=11 Participants	1 Participants n=159 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=70 Participants	1 Participants n=78 Participants	0 Participants n=11 Participants	3 Participants n=159 Participants
Race/Ethnicity, Customized Other	1 Participants n=70 Participants	2 Participants n=78 Participants	0 Participants n=11 Participants	3 Participants n=159 Participants
Race/Ethnicity, Customized Missing	0 Participants n=70 Participants	1 Participants n=78 Participants	0 Participants n=11 Participants	1 Participants n=159 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=70 Participants	8 Participants n=78 Participants	0 Participants n=11 Participants	14 Participants n=159 Participants
Race/Ethnicity, Customized Non-hispanic	64 Participants n=70 Participants	70 Participants n=78 Participants	11 Participants n=11 Participants	145 Participants n=159 Participants
Target Area Hair Count (TAHC) Within Left 1 cm^2 Circular Area	136.7 terminal hairs/cm^2 STANDARD_DEVIATION 55.81 • n=61 Participants • Participants from mITT with data available for analysis at the given timepoint.	148.6 terminal hairs/cm^2 STANDARD_DEVIATION 64.58 • n=70 Participants • Participants from mITT with data available for analysis at the given timepoint.	139.9 terminal hairs/cm^2 STANDARD_DEVIATION 47.72 • n=11 Participants • Participants from mITT with data available for analysis at the given timepoint.	142.8 terminal hairs/cm^2 STANDARD_DEVIATION 59.67 • n=142 Participants • Participants from mITT with data available for analysis at the given timepoint.

PRIMARY outcome

Timeframe: Baseline (Day 1) to Week 24

Population: mITT population included all randomized participants who received study intervention and had a baseline and at least 1 postbaseline measurement for 1 of the coprimary efficacy measures. As per protocol Amendment 1, Finasteride arm group was not included in the analysis model. Number analyzed is participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant n=70 Participants Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Change From Baseline in Target Area Hair Count (TAHC) at Week 24	6.7 terminal hairs/cm^2 Standard Error 3.25	7.1 terminal hairs/cm^2 Standard Error 3.03

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant n=78 Participants Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Subject Self-Assessment (SSA) Score in Hair Growth at Week 24	-0.2 score on a scale Standard Error 0.15	-0.3 score on a scale Standard Error 0.14

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Setipiprant

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Finasteride

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=73 participants at risk Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant n=81 participants at risk Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.	Finasteride n=12 participants at risk Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Infections and infestations Cellulitis	1.4% 1/73 • From first dose of study drug up to 8 weeks post last dose (Up to 32 weeks) Safety population included all the participants who received at least 1 dose of study intervention.	0.00% 0/81 • From first dose of study drug up to 8 weeks post last dose (Up to 32 weeks) Safety population included all the participants who received at least 1 dose of study intervention.	0.00% 0/12 • From first dose of study drug up to 8 weeks post last dose (Up to 32 weeks) Safety population included all the participants who received at least 1 dose of study intervention.
Nervous system disorders Multiple sclerosis	1.4% 1/73 • From first dose of study drug up to 8 weeks post last dose (Up to 32 weeks) Safety population included all the participants who received at least 1 dose of study intervention.	0.00% 0/81 • From first dose of study drug up to 8 weeks post last dose (Up to 32 weeks) Safety population included all the participants who received at least 1 dose of study intervention.	0.00% 0/12 • From first dose of study drug up to 8 weeks post last dose (Up to 32 weeks) Safety population included all the participants who received at least 1 dose of study intervention.

Other adverse events

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER