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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Setipiprant | Experimental | Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks. |
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| Placebo | Placebo Comparator | Two placebo tablets BID at 12-hour intervals for 24 weeks. |
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| Finasteride | Active Comparator | Finasteride 1 mg tablet, orally, once daily for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Setipiprant | Drug | Setipiprant tablets, orally, BID for 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) to Week 24 |
| 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. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Androgenetic Alopecia in Males
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| Name | Affiliation | Role |
|---|---|---|
| Joan-En Lin | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Petrus Center for Aesthetic Surgery & Hair Transplantation |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two placebo tablets, twice daily (BID) at 12-hour intervals for 24 weeks. |
| FG001 | Setipiprant | Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2017 | Mar 15, 2019 |
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| Placebo | Drug | Placebo tablets, orally, BID for 24 weeks. |
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| Finasteride | Drug | Finasteride tablet, orally, once daily for 24 weeks. |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| Radiant Research, Inc. | Santa Rosa | California | 95405 | United States |
| DeNova Research | Chicago | Illinois | 60611 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Michigan Center for Skin Care Research | Clinton Township | Michigan | 48038 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| University of Minnesota Department of Dermatology Division of Clinical research | Minneapolis | Minnesota | 55455 | United States |
| Wake Forest University Health Sciences Department of Dermatology Medical Center Boulevard | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic, Dept of Dermatology | Cleveland | Ohio | 44195 | United States |
| NW Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Penn State Hershey Medical Center Dermatology Research Office | Hershey | Pennsylvania | 17033 | United States |
| Radiant Research, Inc. | Greer | South Carolina | 29650 | United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| Suzzane Bruce and Associates P.A., The Center for Skin Research | Katy | Texas | 77494 | United States |
| The Education & Research Foundation, Inc | Lynchburg | Virginia | 24501 | United States |
| FG002 | Finasteride | Finasteride 1 mg tablet, orally, once daily for 24 weeks. |
| Safety Population (Treated) |
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| mITT Population |
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| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Two placebo tablets BID at 12-hour intervals for 24 weeks. |
| BG001 | Setipiprant | Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks. |
| BG002 | Finasteride | Finasteride 1 mg tablet, orally, once daily for 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Target Area Hair Count (TAHC) Within Left 1 cm^2 Circular Area | 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. | Participants from mITT with data available for analysis at the given timepoint. | Mean | Standard Deviation | terminal hairs/cm^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | terminal hairs/cm^2 | Baseline (Day 1) to Week 24 |
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| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 24 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Two placebo tablets BID at 12-hour intervals for 24 weeks. | 0 | 73 | 2 | 73 | 26 | 73 |
| EG001 | Setipiprant | Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks. | 0 | 81 | 0 | 81 | 28 | 81 |
| EG002 | Finasteride | Finasteride 1 mg tablet, orally, once daily for 24 weeks. | 0 | 12 | 0 | 12 | 6 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Libido decreased | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Skin abrasion | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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Due to change in planned analysis, data of participants in the finasteride arm group were not included in the efficacy analysis.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2018 | Mar 15, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C583159 | 2-(2-(1-naphthoyl)-8-fluoro-3,4-dihydro-1H-pyrido(4,3-b)indol-5(2H)-yl)acetic acid |
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
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