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The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib Administration | Experimental | 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib Administration | Drug | 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Skindex 16 Scores | Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett King, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27699252 | Derived | Kennedy Crispin M, Ko JM, Craiglow BG, Li S, Shankar G, Urban JR, Chen JC, Cerise JE, Jabbari A, Winge MC, Marinkovich MP, Christiano AM, Oro AE, King BA. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI Insight. 2016 Sep 22;1(15):e89776. doi: 10.1172/jci.insight.89776. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib Administration | 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib Administration | 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss) | Posted | Mean | Standard Deviation | percent change in SALT score | 3 months |
|
|
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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 | Tofacitinib Administration | 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cold | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett King, MD | Yale Univ School of Medicine | 2037854092 | brett.king@yale.edu |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| C537055 | Alopecia universalis |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Mean Change in Skindex 16 Scores | Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition | Posted | Mean | Full Range | units on a scale | 3 months |
|
|
|
| 0 |
| 30 |
| 18 |
| 30 |
| sinus infection | Infections and infestations | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| night sweats | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |