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This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP-543 12 mg BID | Experimental | Participants received 1 x 12 milligrams (mg) CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks. |
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| CTP-543 24 mg QD | Experimental | Participants received 24 mg (2 x 12 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-543 | Drug | Administered as 12 mg tablets. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score). | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Center for Dermatology and Skin Surgery | Centennial | Colorado | 80111 | United States | ||
| ForCare Clinical Research |
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94 participants were screened out of which 66 participants who experienced an episode of hair loss due to alopecia areata were enrolled and randomized to receive CTP-543 12 milligrams (mg) twice daily (BID) or CTP-543 24 mg once daily (QD).
Participants were enrolled at 12 study centers in Canada and the United States from 24 May 2019 to 10 April 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | CTP-543 12 mg BID | Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks. |
| FG001 | CTP-543 24 mg QD | Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD 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 | Jul 25, 2019 | Apr 4, 2023 |
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| CTP-543 Matching Placebo |
| Drug |
Administered as tablets to aid treatment masking. |
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| Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score). | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score). | Baseline, Weeks 4, 8, 12, 16 and 20 |
| Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to Weeks 8, 12 and 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level. | Baseline, Weeks 8, 12 and 24 |
| From first dose up to 28 weeks |
| Tampa |
| Florida |
| 33613 |
| United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Guelph Dermatology Research | Guelph | Ontario | N1L 0B7 | Canada |
| Dr Wei Jing Loo Medicine Professional Corporation | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| The Centre for Clinical Trials | Oakville | Ontario | L6J 7W5 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N4 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| Safety Population | Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received. |
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| mITT Population | Modified Intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
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| ID | Title | Description |
|---|---|---|
| BG000 | CTP-543 12 mg BID | Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks. |
| BG001 | CTP-543 24 mg QD | Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks. |
| BG002 | 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: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Severity of Alopecia Tool (SALT) Score | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). | Mean | Standard Deviation | score on a scale |
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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 | Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score). | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 |
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| Secondary | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported. | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | Posted | Number | percentage of participants | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score). | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([baseline SALT score - follow-up SALT score]/baseline SALT score). | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | Posted | Mean | Standard Deviation | percent change | Baseline, Weeks 4, 8, 12, 16 and 20 |
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| Secondary | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to Weeks 8, 12 and 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level. | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized, with data available for analysis. Number analyzed indicates the number of participants with available data for analysis at the specific timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 8, 12 and 24 |
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| Other Pre-specified | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. | Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received. | Posted | Count of Participants | Participants | From first dose up to 28 weeks |
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From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
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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 | CTP-543 12 mg BID | Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks. | 0 | 34 | 0 | 34 | 28 | 34 |
| EG001 | CTP-543 24 mg QD | Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks. | 0 | 32 | 1 | 32 | 24 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Seasonal allergy | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Folliculitis | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Nasopharyngitis | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Sinusitis | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Upper respiratory tract infection | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Urinary tract infection | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood bicarbonate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen E. Hamilton | Concert Pharmaceuticals, Inc. | 781-860-0045 | AAclinicaltrial_inquiries@concertpharma.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2020 | Apr 4, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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