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

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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:

Information provided by (Responsible Party):

Allergan

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Alopecia
Interventions	Drug: Setipiprant Drug: Placebo Drug: Finasteride
Enrollment	169

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Placebo	Setipiprant	Finasteride
Arm/Group Description	Two placebo tablets, twice daily (B...	Setipiprant 1000 mg (2 X 500 mg) ta...	Finasteride 1 mg tablet, orally, on...
Arm/Group Description	Two placebo tablets, twice daily (BID) at 12-hour intervals for 24 weeks.	Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.	Finasteride 1 mg tablet, orally, once daily for 24 weeks.
Period Title: Overall Study
Started	74	83	12
Safety Population (Treated)	73	81	12
mITT Population	70	78	11
Completed	48	57	8
Not Completed	26	26	4
Reason Not Completed
Adverse Event	2	6	1
Withdrawal of Consent	11	12	2
Lost to Follow-up	11	8	1
Non-Compliance with Study Drug	2	0	0

Baseline Characteristics

Arm/Group Title		Placebo	Setipiprant	Finasteride	Total
Arm/Group Description		Two placebo tablets BID at 12-hour ...	Setipiprant 1000 mg (2 X 500 mg) ta...	Finasteride 1 mg tablet, orally, on...	Total of all reporting groups
Arm/Group Description		Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.	Finasteride 1 mg tablet, orally, once daily for 24 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		70	78	11	159
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Modified Intent-to-Treat (mITT) population included all randomized participants who received study intervention in the study and had a baseline and at least 1 postbaseline measurement for one of the coprimary efficacy measures.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	70 participants	78 participants	11 participants	159 participants
		36.9 (6.08)	36.3 (6.69)	34.1 (3.05)	36.4 (6.25)
Sex/Gender, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	70 participants	78 participants	11 participants	159 participants
	Male	70 100.0%	78 100.0%	11 100.0%	159 100.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	70 participants	78 participants	11 participants	159 participants
	White	59 84.3%	70 89.7%	9 81.8%	138 86.8%
	Black or African American	4 5.7%	3 3.8%	0 0.0%	7 4.4%
	Asian	4 5.7%	1 1.3%	1 9.1%	6 3.8%
	American Indian or Alaska Native	0 0.0%	0 0.0%	1 9.1%	1 0.6%
	Native Hawaiian or Other Pacific Islander	2 2.9%	1 1.3%	0 0.0%	3 1.9%
	Other	1 1.4%	2 2.6%	0 0.0%	3 1.9%
	Missing	0 0.0%	1 1.3%	0 0.0%	1 0.6%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	70 participants	78 participants	11 participants	159 participants
	Hispanic	6 8.6%	8 10.3%	0 0.0%	14 8.8%
	Non-hispanic	64 91.4%	70 89.7%	11 100.0%	145 91.2%
Target Area Hair Count (TAHC) Within Left 1 cm^2 Circular Area ^[1] [2] Mean (Standard Deviation) Unit of measure: Terminal hairs/cm^2
	Number Analyzed	61 participants	70 participants	11 participants	142 participants
		136.7 (55.81)	148.6 (64.58)	139.9 (47.72)	142.8 (59.67)
		[1] Measure Description: TAHC was measured using digital imaging analysis (macrophotographs) and was reported in terminal hairs/centimeters squared (cm^2). It is a standardized objective quantification of number of hairs within a prespecified target area of scalp at different timepoints. Target area used to count TAHC was 1 cm^2 circular area of clipped hair located at anterior leading edge of vertex thinning area of scalp and centered with a semi-permanent microdot tattoo to ensure same target area was reproduced at each visit. [2] Measure Analysis Population Description: Participants from mITT with data available for analysis at the given timepoint.

Outcome Measures

1.Primary Outcome


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 t...
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

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Placebo	Setipiprant
Arm/Group Description:	Two placebo tablets BID at 12-hour ...	Setipiprant 1000 mg (2 X 500 mg) ta...
Arm/Group Description:	Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Overall Number of Participants Analyzed	61	70
Least Squares Mean (Standard Error) Unit of Measure: terminal hairs/cm^2
	6.7 (3.25)	7.1 (3.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Setipiprant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9239
	Comments	P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age and baseline TAHC value, with the Type III sum of squares.
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Least-squares Mean Difference
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95% -8.38 to 9.23
	Parameter Dispersion	Type: Standard Error of the Mean Value: 4.45
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Subject Self-Assessment (SSA) Score in Hair Growth at Week 24
Description	The SSA consisted of a single-item measure that assesses each particip...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Placebo	Setipiprant
Arm/Group Description:	Two placebo tablets BID at 12-hour ...	Setipiprant 1000 mg (2 X 500 mg) ta...
Arm/Group Description:	Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Overall Number of Participants Analyzed	68	78
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
	-0.2 (0.15)	-0.3 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Setipiprant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9101
	Comments	P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age, with the Type III sum of squares.
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Least-squares Mean Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95% -0.42 to 0.37
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.20
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	From first dose of study drug up to 8 weeks post last dose (Up to 32 weeks)
Adverse Event Reporting Description	Safety population included all the participants who received at least 1 dose of study intervention.

Arm/Group Title	Placebo	Setipiprant	Finasteride
Arm/Group Description	Two placebo tablets BID at 12-hour ...	Setipiprant 1000 mg (2 X 500 mg) ta...	Finasteride 1 mg tablet, orally, on...
Arm/Group Description	Two placebo tablets BID at 12-hour intervals for 24 weeks.	Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.	Finasteride 1 mg tablet, orally, once daily for 24 weeks.
All-Cause Mortality
	Placebo	Setipiprant	Finasteride
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/73 (0.00%)	0/81 (0.00%)	0/12 (0.00%)
Serious Adverse Events Serious Adverse Events
	Placebo	Setipiprant	Finasteride
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/73 (2.74%)	0/81 (0.00%)	0/12 (0.00%)
Infections and infestations
Cellulitis ^† 1	1/73 (1.37%)	0/81 (0.00%)	0/12 (0.00%)
Nervous system disorders
Multiple sclerosis ^† 1	1/73 (1.37%)	0/81 (0.00%)	0/12 (0.00%)
1 Term from vocabulary, MedDRA 21.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Placebo	Setipiprant	Finasteride
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	26/73 (35.62%)	28/81 (34.57%)	6/12 (50.00%)
Gastrointestinal disorders
Diarrhoea ^† 1	2/73 (2.74%)	4/81 (4.94%)	1/12 (8.33%)
Vomiting ^† 1	0/73 (0.00%)	1/81 (1.23%)	1/12 (8.33%)
Abdominal pain ^† 1	1/73 (1.37%)	3/81 (3.70%)	0/12 (0.00%)
Abdominal pain upper ^† 1	0/73 (0.00%)	2/81 (2.47%)	0/12 (0.00%)
Constipation ^† 1	2/73 (2.74%)	0/81 (0.00%)	0/12 (0.00%)
Nausea ^† 1	3/73 (4.11%)	1/81 (1.23%)	0/12 (0.00%)
General disorders
Fatigue ^† 1	1/73 (1.37%)	0/81 (0.00%)	1/12 (8.33%)
Immune system disorders
Skin abrasion ^† 1	0/73 (0.00%)	1/81 (1.23%)	1/12 (8.33%)
Infections and infestations
Upper respiratory tract infection ^† 1	0/73 (0.00%)	6/81 (7.41%)	2/12 (16.67%)
Bronchitis ^† 1	1/73 (1.37%)	2/81 (2.47%)	0/12 (0.00%)
Gastroenteritis ^† 1	1/73 (1.37%)	2/81 (2.47%)	0/12 (0.00%)
Influenza ^† 1	3/73 (4.11%)	1/81 (1.23%)	0/12 (0.00%)
Nasopharyngitis ^† 1	3/73 (4.11%)	3/81 (3.70%)	0/12 (0.00%)
Sinusitis ^† 1	4/73 (5.48%)	3/81 (3.70%)	0/12 (0.00%)
Investigations
Aspartate aminotransferase increased ^† 1	2/73 (2.74%)	6/81 (7.41%)	1/12 (8.33%)
Alanine aminotransferase increased ^† 1	3/73 (4.11%)	4/81 (4.94%)	0/12 (0.00%)
Weight increased ^† 1	2/73 (2.74%)	4/81 (4.94%)	0/12 (0.00%)
White blood cell count increased ^† 1	3/73 (4.11%)	0/81 (0.00%)	0/12 (0.00%)
Blood glucose increased ^† 1	3/73 (4.11%)	0/81 (0.00%)	0/12 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/73 (0.00%)	0/81 (0.00%)	1/12 (8.33%)
Nervous system disorders
Headache ^† 1	1/73 (1.37%)	3/81 (3.70%)	0/12 (0.00%)
Psychiatric disorders
Libido decreased ^† 1	0/73 (0.00%)	0/81 (0.00%)	2/12 (16.67%)
Agitation ^† 1	0/73 (0.00%)	0/81 (0.00%)	1/12 (8.33%)
Reproductive system and breast disorders
Testicular pain ^† 1	2/73 (2.74%)	0/81 (0.00%)	0/12 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	0/73 (0.00%)	0/81 (0.00%)	1/12 (8.33%)
Oropharyngeal pain ^† 1	0/73 (0.00%)	0/81 (0.00%)	1/12 (8.33%)
Tonsillar hypertrophy ^† 1	0/73 (0.00%)	2/81 (2.47%)	0/12 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus ^† 1	0/73 (0.00%)	0/81 (0.00%)	1/12 (8.33%)
Rash generalised ^† 1	0/73 (0.00%)	0/81 (0.00%)	1/12 (8.33%)
Acne ^† 1	0/73 (0.00%)	2/81 (2.47%)	0/12 (0.00%)
Hair growth abnormal ^† 1	1/73 (1.37%)	3/81 (3.70%)	0/12 (0.00%)
Swelling face ^† 1	0/73 (0.00%)	0/81 (0.00%)	1/12 (8.33%)
Vascular disorders
Hypertension ^† 1	1/73 (1.37%)	2/81 (2.47%)	0/12 (0.00%)
1 Term from vocabulary, MedDRA 21.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

Due to change in planned analysis, data of participants in the finasteride arm group were not included in the efficacy analysis.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Therapeutic Area, Head
Organization:	Allergan
Phone:	714-246-4500
EMail:	clinicaltrials@allergan.com

Layout table for additonal information

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT02781311
Other Study ID Numbers:	1922-201-002
First Submitted:	May 20, 2016
First Posted:	May 24, 2016
Results First Submitted:	March 15, 2019
Results First Posted:	April 5, 2019
Last Update Posted:	April 5, 2019

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