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This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and <65 years) who have 50% or greater scalp hair loss. 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). It is 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 |
|---|---|---|---|
| Jaktinib 50mg BID | Experimental | Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks. |
|
| Jaktinib 75mg BID | Experimental | Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks. |
|
| placebo | Placebo Comparator | Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24 | SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 50% Improvement of SALT (SALT50) | Percentage of participants achieving SALT50 | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| Hospital for Skin Diseases, Chinese Academy of medical Sciences |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| placebo |
| Drug |
Administered orally. |
|
| Nanjing |
| Jiangsu |
| 210042 |
| China |
| D017437 |
| Skin and Connective Tissue Diseases |