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The goal of this clinical trial is to evaluate the efficacy and safety of JYP0061 in adult patients with moderate-to-severe atopic dermatitis. The main questions it aims to answer are:
Participants will:
The goal of this clinical trial is to assess JYP0061 for efficacy and safety in adult patients with moderate-to-severe atopic dermatitis. The main objectives it aims to address are the determination of the drug's therapeutic effect and its safety profile in this patient population. Upon providing written informed consent after being briefed on the study details and potential risks, participants will enter a screening period of up to 4 weeks to confirm their eligibility.
The main tasks for participants will include:
Following the treatment phase, all participants, whether they have completed the treatment course on schedule or have discontinued early, will be monitored for an additional 4 weeks to further evaluate safety post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYP0061 15 mg Group | Experimental | Participants in this arm will receive 15 mg of JYP0061 once daily for a total treatment period of 12 weeks. |
|
| JYP0061 30 mg Group | Experimental | articipants in this arm will receive 30 mg of JYP0061 once daily for a total treatment period of 12 weeks. |
|
| Placebo Group | Placebo Comparator | Participants in this arm will receive a placebo once daily for a total treatment period of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYP0061 15 mg | Drug | Participants in the JYP0061 15 mg group will receive a 15 mg oral tablet of JYP0061 once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline. | The Eczema Area and Severity Index (EASI) is a measure of eczema severity, combining area coverage and symptom intensity (erythema, edema/papulation, excoriation, lichenification) for four body regions. EASI scores range from 0 (no eczema) to 72 (maximum severity), with higher scores indicating worse outcomes. This primary outcome assesses the proportion of participants who achieve at least a 75% reduction in EASI from baseline to Week 12. | Evaluations will be conducted weekly for up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving EASI 75 at Weeks 2, 4, and 8. | Percentage of participants achieving a 75% reduction in EASI from baseline at each specified week. | Weeks 2, 4, and 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 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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| JYP0061 30 mg | Drug | articipants in the JYP0061 30 mg group will receive a 30 mg oral tablet of JYP0061 once daily for 12 weeks. |
|
| Placebo | Drug | Participants in the placebo group will receive a matching placebo tablet once daily for 12 weeks. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |