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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002432-93 | EudraCT Number | ||
| U1111-1130-8441 | Other Identifier | WHO |
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This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0114-0006 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0114-0006 | Drug | A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Crohn's disease activity index (CDAI) | Week 0, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CDAI | Week 0, week 12 | |
| Clinical remission, defined as CDAI of less than 150 | At week 8 | |
| Change in the inflammatory bowel disease questionnaire (IBDQ) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tucson | Arizona | 85710 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| placebo | Drug | A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator. |
|
| Week 0, week 4 |
| Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores | Week 0, week 4 |
| Incidence of adverse events (AEs) | Up to weeks 24 or 36 |
| Incidence of anti-NNC0114-0006 antibodies | Up to weeks 24 or 36 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Novo Nordisk Investigational Site | Little Rock | Arkansas | 72212 | United States |
| Novo Nordisk Investigational Site | Laguna Hills | California | 92653 | United States |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33759 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33136 | United States |
| Novo Nordisk Investigational Site | Jefferson City | Missouri | 65109 | United States |
| Novo Nordisk Investigational Site | Jackson | Tennessee | 38305 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77062 | United States |
| Novo Nordisk Investigational Site | Sofia | 1431 | Bulgaria |
| Novo Nordisk Investigational Site | Sofia | 1527 | Bulgaria |
| Novo Nordisk Investigational Site | Varna | 9010 | Bulgaria |
| Novo Nordisk Investigational Site | Hradec Králové | 500 12 | Czechia |
| Novo Nordisk Investigational Site | Olomouc | 775 00 | Czechia |
| Novo Nordisk Investigational Site | Olomouc | 77520 | Czechia |
| Novo Nordisk Investigational Site | Prague | 15006 | Czechia |
| Novo Nordisk Investigational Site | Częstochowa | 42-202 | Poland |
| Novo Nordisk Investigational Site | Szczecin | 71-252 | Poland |
| Novo Nordisk Investigational Site | Banská Bystrica | 974 05 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 831 04 | Slovakia |
| Novo Nordisk Investigational Site | Ružomberok | 034 26 | Slovakia |
| Novo Nordisk Investigational Site | Barcelona | 08022 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08028 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28942 | Spain |
| Novo Nordisk Investigational Site | Santander | 39008 | Spain |
| Novo Nordisk Investigational Site | Seville | 41013 | Spain |
| Novo Nordisk Investigational Site | Seville | 41014 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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