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This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.
The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 Dose#1 | Active Comparator |
| |
| SHR0302 Dose#2 | Active Comparator |
| |
| SHR0302 Dose#3 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | Oral tablets taken once daily (QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in Severity of Alopecia Tool (SALT) score | Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss | week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Dermatology Research | Northridge | California | 91324 | United States | ||
| Moore Clinical Research |
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| Brandon |
| Florida |
| 33511 |
| United States |
| Dawes Fretzin Clinical Research | Indianapolis | Indiana | 46250 | United States |
| Skin Search of Rochester, Inc | Rochester | New York | 14623 | United States |
| Dermatologists of Southwest Ohio | Mason | Ohio | 45040 | United States |
| The Skin Wellness Center | Knoxville | Tennessee | 37922 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| St George Dermatology and Skin Cancer Centre | Kogarah | New South Wales | 2217 | Australia |
| Novatrials | Kogarah | New South Wales | 2289 | Australia |
| Veracity Clinical Research | Woolloongabba | Queensland | 4102 | Australia |
| Skin Health Institute | Carlton | Victoria | 3053 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Sinclair Dermatology | Melbourne | Victoria | 3002 | Australia |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
| Chongqing Traditional Chinese medicine Hospital | Chongqing | Chongqing Municipality | 400011 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510030 | China |
| The Dermatology Hospital of Nanfang Medical University | Guangzhou | Guangdong | China |
| The Dermatology Hospital of Nanfang Medical University | Guangzhou | Guangzhou | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| Jiangsu Province People's Hospital | Nanjin | Jiangsu | 210029 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | 200071 | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | 300120 | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310020 | China |
| 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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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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