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This is a randomized, double-blind, placebo-controlled, multicenter, and proof of concept study with a parallel group design to evaluate the safety and efficacy of oral Trichuris Suis Ova (TSO) suspension, as compared to placebo, in patients with moderately to severely active Crohn's disease. This study will also have an optional open-label extension for patients completing the double-blind phase of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| TSO 7500 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trichuris suis ova (TSO) | Biological | TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI) | CDAI >= 100 point reduction from baseline | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nova Silver | Coronado Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visions Clinical Research - Tucson | Tucson | Arizona | 85712 | United States | ||
| Lynn Institue of the Ozarks |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses) |
| FG001 | TSO 7500 | Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Biological | Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses) |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
| Rokay Kamyar, MD Inc | La Mesa | California | 91941 | United States |
| Medvin Clinical Research | La Mirada | California | 90638 | United States |
| Lakewood Primary Care Medical Group, Inc | Lakewood | California | 90712 | United States |
| Alliance Research | Long Beach | California | 90804 | United States |
| Collaborative Neuroscience Network, Inc. | Long Beach | California | 90806 | United States |
| Alliance Clinical Research, LLC | Oceanside | California | 92056 | United States |
| Digestive Care Associates | San Carlos | California | 94070 | United States |
| San Diego Clinical Trials | San Diego | California | 92120 | United States |
| Gastroenterology of the Rockies | Lafayette | Colorado | 80026 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Sanitas Research | Coral Gables | Florida | 33134 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Florida Medical Research Institute | Gainesville | Florida | 32607 | United States |
| The Center for Gastrointestinal Disorders | Hollywood | Florida | 33021 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32204 | United States |
| Gastroenterology Associates of Osceola | Kissimmee | Florida | 34741 | United States |
| Sunrise Medical Research | Lauderdale Lakes | Florida | 33319 | United States |
| Paramount Public Health & Research Management Services | Miami | Florida | 33135 | United States |
| Community Research Foundation, Inc | Miami | Florida | 33155 | United States |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | United States |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 336003 | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | United States |
| Selah Medical Center | Boise | Idaho | 83704 | United States |
| Northwest Gastroenterologists | Arlington Heights | Illinois | 60005 | United States |
| Suburban Clinical Research | Bolingbrook | Illinois | 60490 | United States |
| Suburban Clinical Research | Burr Ridge | Illinois | 60527 | United States |
| The University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| Medisphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Cotton O'Neil Digestive Healthcare | Topeka | Kansas | 66606 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health Services | Ann Arbor | Michigan | 48109 | United States |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | United States |
| Beyer Research | Kalamazoo | Michigan | 49009 | United States |
| Midwest Center for Clinical Research | Lee's Summit | Missouri | 64064 | United States |
| Center for Digestive and Liver Disease | Mexico | Missouri | 65265 | United States |
| Billings Clinic Research Center | Billings | Montana | 59101 | United States |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | United States |
| Reno Clinical Trials | Sparks | Nevada | 89434 | United States |
| South Jersey Medical Associates, P.A. | Blackwood | New Jersey | 08012 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Digestive Health Physicians | Cheektowaga | New York | 14225 | United States |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | United States |
| Metropolitan Research Associates | New York | New York | 10016 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Clinical Trials of America, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Consultants for Clinical Research, Inc | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University-Inflammatory Bowel Disease Ctr | Columbus | Ohio | 43210 | United States |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | United States |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | United States |
| Northwest Gastroenterology Clinic, LLD | Portland | Oregon | 97210 | United States |
| James J. Boylan Gastroenterology and Liver Diseases | Bethlehem | Pennsylvania | 18015 | United States |
| Shirish A. Amin, MD, PC | Indiana | Pennsylvania | 15701 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Donald Guthrie Foundation for Education & Research | Sayre | Pennsylvania | 18840 | United States |
| Cherry Tree Medical | Uniontown | Pennsylvania | 15401 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Austin Gastroenterology PA/Professional Quality Research, Inc | Austin | Texas | 78705 | United States |
| Lovelace Scientific Resources, Inc. | Austin | Texas | 78758 | United States |
| Diagnostic Clinic of Houston | Houston | Texas | 77004 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Gastroenterology Associates of Northern Virginia | Fairfax | Virginia | 22031 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses) |
| BG001 | TSO 7500 | Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI) | CDAI >= 100 point reduction from baseline | all patients randomized and treated with at least 1 dose of study medication | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
12 weeks
no difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses) | 0 | 125 | 6 | 125 | 27 | 125 |
| EG001 | TSO 7500 | Trichuris suis ova (TSO): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses) | 0 | 125 | 3 | 125 | 31 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food Poisoning | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess Intestinal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vein disorder | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
As specified in each clinical trial agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations | Coronado Biosciences | 7816524516 | nsilver@coronadobio.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|