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To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis
If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib 100mg BID | Experimental | Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day |
|
| Jaktinib 75mg BID | Experimental | Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day |
|
| Placebo | Placebo Comparator | Drug: Placebo Orally administered, twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib Hydrochloride Tablet | Drug | Orally administered, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with treatment emergent adverse event (TEAE) | Safety of the drug | 36 weeks after the first dose |
| Number and percentage of subjects with Serious Adverse Event (SAE) | Safety of the drug | 36 weeks after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| The diachronic change in the proportion of subjects whose total Eczema area and severity index (EASI) score decreased by ≥ 75% from baseline | The proportion of subjects who reached EASI-75 | 36 weeks after the first dose |
| The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment (IGA) score reached 0 or 1 and decreased by ≥ 2 points from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Zhang | Contact | +86-0512-57018310 | zhangc@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | 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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The proportion of subjects who reached IGA 0/1 |
| 36 weeks after the first dose |
| The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale (NRS) score improved by ≥ 4 points from baseline | The proportion of subjects who reached NRS4 | 36 weeks after the first dose |
| Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College | Recruiting | Nanjin | Jiangsu | China |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |