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This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.
This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3 cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated sequentially in ascending dose order. Participants will be randomized to either an active dose of CTP-543 or placebo for a 24-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: CTP-543 4 mg BID | Experimental | Participants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks. |
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| Cohort 2: CTP-543 8 mg BID | Experimental | Participants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks. |
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| Cohort 3: CTP-543 12 mg BID | Experimental | Participants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks. |
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| Combined Placebo | Placebo Comparator | Participants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-543 | Drug | Administered as tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline 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). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24. | Week 24 |
| 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. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug. | From first dose of study drug up to safety follow up at Week 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen E. Hamilton | Concert Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States | ||
| Contour Dermatology & Cosmetic Surgery Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 2019 American Academy of Dermatology Meeting; 01-05 March 2019; Washington, DC. Abstract 11291. | ||
| Background | Cassella J, Hamilton C, von Hehn J, Braman V. JAK Inhibitor CTP-543 Achieves Primary Endpoint in Phase 2 Trial in Alopecia Areata. In: Proceedings from the 11th World Congress Hair Research; 24-27 April 2019; Sitges, Barcelona. | ||
| Background | Cassella J, Hamilton C, von Hehn J, Braman V. CTP-543, an oral JAK inhibitor, achieves primary endpoint in Phase 2 randomized, placebo-controlled, dose ranging trial in patients with moderate to severe alopecia areata. In: Proceedings from the 28th EADV Congress; 09-13 October 2019, Madrid, Spain. D3T01.1: Late breaking news. |
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235 participants were screened, out of which 149 participants who experienced an episode of hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.
Participants were enrolled at 13 study centers in the United States from 09 August 2017 to 08 July 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Placebo | Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3. |
| FG001 | Cohort 1: CTP-543 4 mg BID | Participants received CTP-543 4 mg tablets, twice daily for up to 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 21, 2019 | Jun 3, 2022 |
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| CTP-543 matching placebo | Drug | Administered as tablets. |
|
| Rancho Mirage |
| California |
| 92270 |
| United States |
| Stanford University School of Medicine | Redwood City | California | 94064 | United States |
| Kaiser Permanente Northern California | San Francisco | California | 94118 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06519 | United States |
| Siperstein Dermatology Group | Boynton Beach | Florida | 33472 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27104 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Northwest Dermatology | Portland | Oregon | 97210 | United States |
| Suzanne Bruce & Associates, PA | Houston | Texas | 77056 | United States |
| FG002 | Cohort 2: CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks. |
| FG003 | Cohort 3: CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks. |
| Safety Population | 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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| 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 | Combined Placebo | Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3. |
| BG001 | Cohort 1: CTP-543 4 mg BID | Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks. |
| BG002 | Cohort 2: CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks. |
| BG003 | Cohort 3: CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks. |
| BG004 | 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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| 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 | Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline 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). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24. | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment during the treatment period. Participants were analyzed according to their randomized treatment group. | Posted | Number | Percentage of participants | Week 24 |
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| Primary | 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. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug. | 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. | Posted | Count of Participants | Participants | From first dose of study drug up to safety follow up at Week 28 |
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From first dose of study drug up to safety follow up at Week 28
All-cause mortality, Serious and other adverse events are reported for the 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 | Combined Placebo | Participants received CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3. | 0 | 44 | 0 | 44 | 31 | 44 |
| EG001 | Cohort 1: CTP-543 4 mg BID | Participants received CTP-543 4 mg tablets, twice daily for up to 24 weeks. | 0 | 29 | 0 | 29 | 25 | 29 |
| EG002 | Cohort 2: CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks. | 0 | 38 | 0 | 38 | 31 | 38 |
| EG003 | Cohort 3: CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks. | 0 | 36 | 1 | 36 | 30 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Body tinea | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Hemoglobin decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Hematocrit decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 19.1 | 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 | May 7, 2019 | Apr 8, 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Other |
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| Superiority |
| Chi-squared | <0.001 | Superiority |
Participants received CTP-543 8 mg tablets, twice daily for up to 24 weeks. |
| OG003 | Cohort 3: CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, twice daily for up to 24 weeks. |
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