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The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for risankizumab by subcutaneous (SC) injection. |
|
| Risankizumab | Experimental | Risankizumab by subcutaneous (SC) injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risankizumab | Drug | rizankizumab subcutaneous (SC) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16 | The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Week 16 |
| Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713 | Krasnodar | Krasnodarskiy Kray | 350020 | Russia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35917057 | Derived | Odnopozova L, Edin A, Sukharev A, Wu T, Aydin K, Kelly M, Khotko A. Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation. Dermatol Ther (Heidelb). 2022 Sep;12(9):2063-2075. doi: 10.1007/s13555-022-00776-0. Epub 2022 Aug 2. |
| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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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 |
|---|---|
| C000601773 | risankizumab |
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| placebo for rizankizumab | Drug | placebo for rizankizumab subcutaneous (SC) infusion |
|
The PASI score is an established measure of clinical efficacy for psoriasis medications. |
| Week 16 |
| Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16 | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Week 16 |
| Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much). | Week 16 |
| Family Outpatient clinic#4 LLC /ID# 207441 |
| Korolev |
| Moscow |
| 141060 |
| Russia |
| SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615 | Saint Petersburg | Sankt-Peterburg | 194021 | Russia |
| LLC ArsVitae Severo-Zapad /ID# 200658 | Saint Petersburg | Sankt-Peterburg | 194223 | Russia |
| LLC Kurator /ID# 200616 | Saint Petersburg | Sankt-Peterburg | 196240 | Russia |
| Alliance Biomedical Ural Group /ID# 201681 | Izhevsk | Udmurtiya Republic | 426061 | Russia |