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Phase III Efficacy and Safety Study of RSS0393 Ointment in Plaque Psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1: RSS0393 ointment 0.03% | Experimental |
| |
| Treatment group 2: RSS0393 ointment placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS0393 ointment 0.03% | Drug | RSS0393 ointment 0.03% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Achieving a Physician's Global Assessment (PGA) response at Week 8 | week8 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants achieving at least a 75% improvement frombaseline in the Psoriasis Area and Severity Index (PASI) score (PASI 75). | week54 | |
| The proportion of participants with a baseline Itch Numerical Rating Scale (Itch-NRS) score ≥4 who achieved an Itch-NRS response (defined as a reduction of ≥4 points from baseline). |
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Inclusion Criteria:
Exclusion Criteria:
Presence of any of the following skin abnormalities or conditions:
The participant is diagnosed with skin diseases or conditions other than plaque psoriasis during the screening period that, in the investigator's opinion, may interfere with the evaluation of study-related endpoints.
Use of any of the following medications or participation in clinical studies:
1) Treatment with topical anti-psoriatic medications within 14 days prior to baseline, or systemic anti-psoriatic therapies or phototherapy within 28 days prior to baseline, or biologics for psoriasis within the protocol-specified washout period prior to baseline.
2) Participation in any clinical study (including investigational vaccines) or medical device trial within 3 months prior to baseline or within 5 elimination half-lives of the prior investigational product (whichever is longer).
3.Presence of any significant medical histories or underlying conditions that may affect safety.
4.Any of the following laboratory abnormalities and/or 12-lead ECG findings at screening/baseline:
5. General Conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuang Li | Contact | 18604031725 | Shuang.li.sl100@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital (PUMCH) | Beijing | Beijing Municipality | 100730 | China |
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| RSS0393 ointment placebo |
| Drug |
RSS0393 ointment placebo |
|
| week54 |
| Achieving an Intertriginous Physician's Global Assessment (I-PGA) response in participants with baseline involvement of intertriginous areas and a baseline I-PGA score ≥ 2. | week54 |
| The proportion of participants achieving a Physician's Global Assessment (PGA) response (score of "clear" or "almost clear") at each of the other scheduled visits. | week 54 |
| Change from baseline in Psoriasis Area and Severity Index (PASI) score (absolute and percentage) at each visit. | week 54 |
| The proportion of participants achieving PASI 50, PASI 90, or PASI 100 at each visit. | week 54 |
| Change from baseline in the Itch Numerical Rating Scale (Itch-NRS) score (absolute and percentage) at each visit. | week 54 |
| Change from baseline in Body Surface Area (BSA) involvement (absolute and percentage) at each visit. | week 54 |
| Change from baseline in the Dermatology Life Quality Index (DLQI) at each visit. | week 54 |
| Adverse Event (AE) | week 54 |
| Local Tolerability Score | week 54 |