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The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.
The study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test.
The main test:The trial set up 4 treatment groups, including 3 dose exploration groups, Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group.
The extended test:Subjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid, 100mg Bid group) subjects still maintain the original dose after 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib 50mg Bid | Experimental | Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid |
|
| Jaktinib 75mg Bid | Experimental | Jaktinib 75mg Bid+ Placebo 100mg Bid |
|
| Jaktinib 100mg Bid | Experimental | Jaktinib 100mg Bid+ Placebo 75mg Bid |
|
| placebo | Placebo Comparator | Placebo 100mg Bid+ Placebo 75mg Bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib | Drug | In the morning: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib; In the evening: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD) | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving IGA of 0 or 1. | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | Treatment at 2,4,8,12,16,20,24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qianjin Lu | Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second xiangya hospital of central south university | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Jaktinib | Drug | In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib; In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib. |
|
| Jaktinib | Drug | In the morning: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib; In the evening: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib. |
|
| placebo | Drug | In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo;In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo. |
|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | Treatment at 2,4,8,12,16,20,24 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |