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The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | SHR-1314 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12 | Week 12 | |
| sPGA of 0 or 1 response at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12; | Week 12; | |
| Percentage of subjects who achieve at least 100% improvement in PASI score (PASI 100) at Week 12 | Week 12 |
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Inclusion Criteria:
Men or women at least 18 years of age at time of screening.
Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
Moderate to severe psoriasis as defined at Baseline/ randomization by:
PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
Body Mass Index (BMI) is 18 kg/m2 or above at screening
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Shen | Contact | 0518-82342973 | Shenyang@hrglobe.cn | |
| Xiaolan Lu | Contact | 0518-82342973 | luxiaolan@hrglobe.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39332633 | Derived | Yan K, Li F, Bi X, Han L, Zhang Z, Chen R, Li Y, Zhang L, Wang X, Li L, Lu J, Xu A, Yang S, Lu Y, Sun J, Li Z, Zhu X, Jiang M, Zhang S, Wang W, Li Y, Meng Z, Li H, Mou K, Han X, Li S, Chen A, Li X, Liu D, Zhang C, Ji C, Wang Y, Cheng H, Cui X, Yao X, Bai X, Dong G, Xu J. Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2025 Jan;92(1):92-99. doi: 10.1016/j.jaad.2024.09.031. Epub 2024 Sep 26. |
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| Drug |
Placebo |
|
| sPGA of 0 response at Week 12 | Week 12 |