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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 8 mg BID | Experimental | Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks. |
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| CTP-543 16 mg QD | Experimental | Participants received 16 mg (2 x 8 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 | CTP-543 administered as 8 mg tablet. |
| |
| 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% Relative 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 With Adverse Events as a Measure of Safety | 24 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen E Hamilton, MS | Concert Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Irvine | California | 92697 | United States | ||
| Investigative Site |
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70 participants were screened out of which 57 participants who experienced an episode of hair loss due to alopecia areata were enrolled and randomized to receive CTP-543 8 mg twice daily (BID) or CTP-543 16 mg once daily (QD).
Participants were enrolled at 10 study centers in the United States from 21 March 2019 to 21 November 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | CTP-543 8 mg BID | Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks. |
| FG001 | CTP-543 16 mg QD | Participants received 16 mg (2 x 8 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 | Jan 3, 2019 | Jun 22, 2022 |
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| CTP-543 Matching Placebo |
| Drug |
Administered as tablets to aid treatment masking. |
|
| Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| Absolute Change in SALT Scores From Baseline 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 in SALT Scores From Baseline 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 | 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 the Week 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, Week 24 |
| San Francisco |
| California |
| 94118 |
| United States |
| Investigative Site | New Haven | Connecticut | 06519 | United States |
| Investigative Site | Boynton Beach | Florida | 33472 | United States |
| Investigative Site | Boston | Massachusetts | 02114 | United States |
| Investigative Site | Boston | Massachusetts | 02115 | United States |
| Investigative Site | Fridley | Minnesota | 55432 | United States |
| Investigative Site | Portsmouth | New Hampshire | 03801 | United States |
| Investigative Site | Winston-Salem | North Carolina | 27104 | United States |
| Investigative Site | Portland | Oregon | 97210 | United States |
| Safety Population | Safety Population included all participants who received study drug. Participants in the safety population were analyzed according to the actual dosing regimen received during the study. |
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| COMPLETED |
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| NOT COMPLETED |
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Randomized Population included all the randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CTP-543 8 mg BID | Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks. |
| BG001 | CTP-543 16 mg QD | Participants received 16 mg (2 x 8 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/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| 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). | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | 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% Relative 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. | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | Posted | Number | 90% Confidence Interval | Percentage of participants | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Absolute Change in SALT Scores From Baseline 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). | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Relative Change in SALT Scores From Baseline 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). | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | 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 | 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 the Week 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. | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | Posted | Number | Percentage of participants | Baseline, Week 24 |
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| Other Pre-specified | Number of Participants With Adverse Events as a Measure of Safety | Not Posted | 24 Weeks | Participants |
Adverse Events: From first dose of study drug up to Week 28; All-cause mortality: Randomization up to Week 28
Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study.
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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 8 mg BID | Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks. | 0 | 29 | 0 | 29 | 23 | 29 |
| EG001 | CTP-543 16 mg QD | Participants received 16 mg (2 x 8 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks. | 0 | 28 | 0 | 28 | 23 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
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| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 21.1 | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2019 | Jun 22, 2022 | SAP_001.pdf |
| 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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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Units | Counts |
|---|---|
| Participants |
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