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Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis.After single asending dose and mutiple asending dose in health subjects. And the patients with moderate to severe plaque psoriasis will be randomized into 4 cohorts(15mg, 30mg, 60mg and placebo) approximately 216 subjects will be enrolled (52 for each cohort ). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients with chronic plaque psoriasis will be treated BID for 16 weeks with placebo in first phase. Then will be treated BID for 36-week extension followed with 30mg of Hemay005. |
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| 15mg Hemay005 | Experimental | Patients with chronic plaque psoriasis will be treated BID for 16 weeks with 15mg Hemay005 in first phase. Then will be treated BID for 36-week extension followed with 15mg of Hemay005. |
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| 30mg Hemay005 | Experimental | Patients with chronic plaque psoriasis will be treated BID for 16 weeks with 30mg Hemay005 in first phase. Then will be treated BID for 36-week extension followed with 30mg of Hemay005. |
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| 60mg Hemay005 | Experimental | Patients with chronic plaque psoriasis will be treated BID for 16 weeks with 60mg Hemay005 in first phase. Then will be treated BID for 36-week extension followed with 60mg of Hemay005. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15mg Hemay005 | Drug | Hemay005 is a small molecule PDE4 inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75). | The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16. | week16 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Adverse Events and Serious Adverse Events. | Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases). | week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Zheng, Dr | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628605 | Hemay005 |
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| Placebos | Drug | Placebos are the same as drugs, but contain no Hemay005. |
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| Cmax of Hemay005. | Maximum observed serum concentration. | week8 |
| Proportion of subjects achieving an overall sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline. | The static Physician's Global Assessment (sPGA) rated the investigator's overall clinical assessment of a participants plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Decreases in sPGA correspond to clinical improvement. | week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56. |