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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002542-38 |
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This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEB071 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEB071 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of induction of remission after 28 days of treatment (using the Partial Mayo Score and the Modified Baron Score), also an Endoscopic biopsy will be taken | Partial Mayo Score throughout entire study, biopsy at end of dosing period |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events) | Throughout entire study | |
| Measurement of drug concentrations in blood | During the dosing period only |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria do apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Mobile | Alabama | 36608 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CAEB071A2210 from the Novartis Clinical Trials website | View source |
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|
| Relationship between drug concentration in blood and disease activity | Dosing period only |
| Mesa |
| Arizona |
| 85213 |
| United States |
| Novartis Investigative Site | Topeka | Kansas | 66606 | United States |
| Novartis Investigative Site | Lafayette | Louisiana | 70501 | United States |
| Novartis Investigative Site | Chesterfield Twp | Michigan | 48047 | United States |
| Novartis Investigative Site | Troy | Michigan | 48098 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Novartis Investigative Site | Aarhus | DK-8000 | Denmark |
| Novartis Investigative Site | Odense C | DK-5000 | Denmark |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Hamburg | 22559 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Kiel | 24105 | Germany |
| Novartis Investigative Site | Leipzig | 04105 | Germany |
| Novartis Investigative Site | Lüneburg | 21339 | Germany |
| Novartis Investigative Site | Minden | 32423 | Germany |
| Novartis Investigative Site | Regensburg | 93053 | Germany |
| Novartis Investigative Site | Stuttgart | 70376 | Germany |
| Novartis Investigative Site | Krakow | 30-307 | Poland |
| Novartis Investigative Site | Poznan | 60-539 | Poland |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
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