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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT number: 2007-007160-19 |
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This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEB071 200 mg BID | Experimental |
| |
| AEB071 400 mg OD | Experimental |
| |
| AEB071 300 mg BID | Experimental |
| |
| Placebo BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| AEB071 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plaque psoriasis as assessed by PASI response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%) | to 12 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs | up to 12 weeks treatment | |
| change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo |
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Inclusion Criteria:
Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy
Severity of disease meeting all of the following three criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arizona | 71913 | United States | ||
| Belleair Research Center, LLC |
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| Label | URL |
|---|---|
| Results for CAEB071C2201 from the Novartis Clinical Trials Results Website | View source |
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|
| up to 12 weeks treatment |
| disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period | in the treatment-free Follow-up Period |
| Pinellas Park |
| Florida |
| 33781 |
| United States |
| Kansas City Dermatology, PA | Overland Park | Kansas | 66215 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Central Dermatology | St Louis | Missouri | 63117 | United States |
| Palmetto Clinical Trial Services | Greenville | South Carolina | 29607 | United States |
| Center for Clinical Studies | Houston | Texas | 77030 | United States |
| Suzanne Bruce & Associates, PA | Houston | Texas | 77056 | United States |
| Virginia Clinical Research | Norfolk | Virginia | 23507 | United States |
| Novartis Investigative site | Buenos Aires | Argentina |
| Novartis Investigative site | Mendoza | Argentina |
| Novartis Investigative site | Benowa | Australia |
| Novartis Investigative site | Carlton | Australia |
| Novartis Investigative site | Kogarah | Australia |
| Novartis Investigative site | Parkville | Australia |
| Novartis Investigative site | Brussels | Belgium |
| Novartis Investigative site | Edegem | Belgium |
| Novartis Investigative site | Liège | Belgium |
| Novartis Investigative site | Berlin | Germany |
| Novartis Investigative site | Bonn | Germany |
| Novartis Investigative site | Erlangen | Germany |
| Novartis Investigative site | Frankfurt | Germany |
| Novartis Investigative site | Hamburg | Germany |
| Novartis Investigative site | Kiel | Germany |
| Novartis Investigative site | Leipzig | Germany |
| Novartis Investigative site | Regensburg | Germany |
| Novartis Investigative Site | Guatemala City | Guatemala |
| Novartis Investigative site | Milan | Italy |
| Novartis Investigative Site | Modena | Italy |
| Novartis Investigative Site | Rome | Italy |
| Novartis Investigative Site | Siena | Italy |
| Novartis Investigative Site | Verona | Italy |
| Novartis Investigative Site | Ankara | Turkey (Türkiye) |
| Novartis Investigative Site | Gaziantep | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | Turkey (Türkiye) |
| Novartis Investigative Site | Manisa | Turkey (Türkiye) |
| Novartis Investigative site | Nuneaton | United Kingdom |
| Novartis Investigative site | Salford | United Kingdom |
| Novartis Investigative site | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D011565 | Psoriasis |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
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