Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Setipiprant Finasteride
Hide 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
Arm/Group Title Placebo Setipiprant Finasteride Total
Hide 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
Hide 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.
1.Primary Outcome
Title Change From Baseline in Target Area Hair Count (TAHC) at Week 24
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
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
Hide 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%) 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
Due to change in planned analysis, data of participants in the finasteride arm group were not included in the efficacy analysis.
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
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02781311     History of Changes
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