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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-31790 | Other Identifier | Stanford University |
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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 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib | Experimental | Participants will receive tofacitinib for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | Tofacitinib 5 mg tablet taken by mouth twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score. | 0 and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony E Oro, M.D., Ph.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27699252 | Result | 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 | Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the protocol are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Tofacitinib (5 mg tablet taken by mouth twice a day) 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 | Median |
| 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 | Percent Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score. | Posted | Median | Full Range | Percent change | 0 and 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 | Treatment Arm | Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony E Oro, M.D., Ph.D. | Stanford University | oro@stanford.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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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 40 |
| 18 |
| 40 |
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dry eyes | Eye disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hot flashes | Endocrine disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Numbness | General disorders | Systematic Assessment |
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| Paronychia | Infections and infestations | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |