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To evaluate the efficacy and safety of RSS0393 ointment in patients with plaque psoriasis Phase II study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | RSS0393 ointment 0.01% |
|
| Treatment group 2 | Experimental | RSS0393 ointment 0.03% |
|
| Treatment group 3 | Placebo Comparator | RSS0393 ointment placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS0393 ointment | Drug | RSS0393 ointment 0.01% |
| |
| RSS0393 ointment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a clinician's overall assessment (PGA) response (defined as a PGA score of 0 (clear) or 1 (nearly clear) with ≥2 points improvement from baseline) | 8weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieved at least 75% improvement (PASI 75) from baseline; | 14weeks | |
| The proportion of subjects with PGA response at each visit | 14weeks | |
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Inclusion Criteria:
Exclusion Criteria:
Present with any of the following medical history or concomitant diseases:
There are the following important medical history or underlying diseases that affect safe
At the time of screening, laboratory tests and/or 12-lead electrocardiogram showed the following:
General situation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuang Li | Contact | 18604031725 | Shuang.li.sl100@hengrui.com |
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| Drug |
RSS0393 ointment 0.03% |
|
| RSS0393 ointment placebo | Drug | RSS0393 ointment placebo |
|
| Absolute and percentage changes in PASI scores at each visit compared to baseline; |
| 14weeks |
| The proportion of subjects who achieved PGA 0 or 1 score at each visit | 14weeks |
| The time of the subject reached PASI 50 within 12 weeks | 14weeks |
| The proportion of participants who achieved at least a 50% improvement (PASI 50) in PASI scores from baseline at each visit | 14weeks |
| Percentage of participants who achieved at least a 90% improvement (PASI 90) from baseline in PASI scores at each visit | 14weeks |
| Absolute and percentage changes in the most intense itch digital score (WI-NRS) from baseline at each visit ; | 14weeks |
| The proportion of subjects with baseline involvement in the intererase area and intererase PGA (I-PGA) score ≥2 who achieved an I-PGA response (defined as an I-PGA of 0 or 1 with ≥2 points improvement from baseline) at each visit | 14weeks |
| The proportion of subjects with baseline involvement and I-PGA score ≥2 who achieved I-PGA score 0 at each visit | 14weeks |
| Absolute value of change in skin quality of life index (DLQI) from baseline at each visit | 14weeks |