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The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
The study is twelve weeks in duration and there are eight weeks of once-daily injections into your abdomen or thigh. There are a total of six visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo solution injected subcutaneously daily into either thigh or abdomen. |
|
| teduglutide 0.05 | Experimental | teduglutide 0.05 mg/kg/d injected subcutaneously daily. |
|
| teduglutide 0.1 | Experimental | 0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen |
|
| teduglutide | Experimental | 0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALX-0600 | Drug | teduglutide |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8. | 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers. | 8 weeks of treatment |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Therapeutics | Tucson | Arizona | 85712 | United States | ||
| Rocky Mountain Gastroenterology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19821509 | Background | Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117. |
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| placebo |
| Drug |
placebo solution injected subcutaneously |
|
| teduglutide 0.05 | Drug | 0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen |
|
|
| teduglutide 0.2 mg | Drug | 0.2 mg/kg/d subcutaneously injected into thigh or abdomen |
|
|
| Teduglutide 0.05 dose | Drug | 0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen |
|
|
| teduglutide 0.1 mg dose | Drug | 0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen |
|
|
| Lakewood |
| Colorado |
| 80401 |
| United States |
| Rx Trials | Washington D.C. | District of Columbia | 20010 | United States |
| Clinical Trials Management of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Venture Research | North Miami Beach | Florida | 33162 | United States |
| Visions Clinical Research - Sarasota | Sarasota | Florida | 34239 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Pinnacle Trials | Atlanta | Georgia | 30329 | United States |
| Saint Joseph's Health System | Atlanta | Georgia | 30342-1764 | United States |
| Northwestern University School of Medicine | Chicago | Illinois | 60619 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| Asher Kornbluth, MD, PC | New York | New York | 10128 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Allegheny General Hospital-Allegheny Ctr for Digestive Diseases | Pittsburgh | Pennsylvania | 15212 | United States |
| Methodist Hospital/Baylor University | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| McGuire DVAMC | Richmond | Virginia | 23249 | United States |
| Dean Foundation Research Center | Madison | Wisconsin | 53715 | United States |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1L5 | Canada |
| Odyssey Research | Victoria | British Columbia | V8T 5G4 | Canada |
| Health Sciences Center | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Queen Elizabeth II Health Sciences | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Life Screening Centres | Toronto | Ontario | M5S 2A5 | Canada |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C438272 | ALX-0600 |
| C494910 | teduglutide |
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