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This study includes a dose escalation part and a dose extension part.
In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers.
The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) : Extension test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1, 0.5% Jaktinib Bid | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily. |
|
| Part 1: Cohort 2,1.5% Jaktinib Bid | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily. |
|
| Part 1: Cohort 3, 2.5% Jaktinib Qd | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily. |
|
| Part 1: Cohort 4, 2.5% Jaktinib Bid | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily. |
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| Dose extension: Vehicle Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib Hydrochloride Cream | Drug | Subjects in each group were scheduled to give the drug for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear | A total PGA score of 0 or 1 or a decrease of ≥2 from baseline | 7 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Response of Clear or Almost Clear From Baseline | PGA score of 0 or 1 | Treatment at 8,16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qianjin Lu, PhD | Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | 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 Vehicle Control cream will be applied topically twice daily |
|
| Dose extension: low-dose group, X% | Experimental | X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily |
|
| Dose extension: high-dose group, Y% | Experimental | Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily |
|
|
| Placebo | Drug | Placebo |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |