Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo
NCT ID: NCT01576471
Last Updated: 2017-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2012-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
TSO 7500
Trichuris suis ova (TSO)
TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
Interventions
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Trichuris suis ova (TSO)
TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
Placebo
Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
Eligibility Criteria
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Inclusion Criteria
2. Patient with established diagnosis of Crohn's disease (CD) for at least 3 months confirmed by endoscopic and histological, or endoscopic and radiological criteria.
3. Patient with localization of CD either in terminal ileum (L1), in colon (L2) or ileocolitis (L3), all without upper gastrointestinal involvement (- L4) according to the Montreal classification (2005).
4. Patient with active, symptomatic CD manifested by CDAI ≥ 220 and ≤ 450 at Baseline.
5. Patient with active intestinal inflammation as visualized by endoscopy within 8 weeks prior to Baseline.
6. Patient is not using concomitant medication for treatment of underlying Crohn's disease with the following exceptions: concomitant medications may include: 1) Oral or rectal sulfasalazine, mesalazine (5-ASA), or mesalazine derivative, if receiving it for \>6 weeks and if receiving the same dose for at least 4 weeks; 2) Oral prednisone up to 15 mg/day, or budesonide if receiving it for \>4 weeks and if receiving the same dose for at least 4 weeks; and 3) Azathioprine (up to 2.5 mg/kg daily) or 6-mercaptopurine (up to 2 mg/kg daily) if receiving it for \>3 months and if receiving the same dose for at least 8 weeks prior to Baseline.
7. Hemoglobin of at least 10 g/dl, normal white blood cell and platelet count \> lower limit of normal at screening.
8. For females of childbearing potential, negative serum pregnancy test prior to enrollment, not breastfeeding for study duration, and willingness to use accepted forms of reliable birth control for study duration \[including bilateral tubal ligation, use of oral contraceptives, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera®, hormonal implants, and total abstinence\]. Pregnancy tests are not required (indicate "N/A") for males or females not of childbearing potential (post-menopausal with last menstrual period \>1 year ago or total hysterectomy).
9. Patient has the ability to provide informed consent.
Exclusion Criteria
2. Patient with ulcerative colitis, indeterminate colitis, or ulcerative proctitis.
3. Bowel surgery in past 6 months prior to Screening.
4. Resection of more than 50 cm of the ileum.
5. Current ileostomy or colostomy.
6. Ongoing or active septic complications, is hospitalized or exhibiting signs of toxicity (sepsis), has symptomatic strictures, or impending obstruction or anticipating a need for blood transfusion for gastrointestinal bleeding or in whom surgical intervention may be imminent.
7. Patient with gastrointestinal abscess or perforation.
8. Patient with fistulae having a new onset within 2 months of Screening with moderate to severe local inflammation.
9. Patient with history of colorectal cancer or colorectal dysplasia. Patients with completely resected sporadic adenomas may be enrolled.
10. Patient requiring parenteral or tube feeding.
11. Patient with current evidence of infectious colitis, e.g., Clostridium difficile, Amoebiasis, Giardia lamblia or stools positive for other enteric pathogens, ova or parasites at Screening.
12. Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
13. Patient with serum creatinine ≥ 2.0 mg/dL; blood urea nitrogen \>40 mg/dL; alkaline phosphatase \> 250 U/L; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 100 U/L; or total bilirubin \>1.5 mg/dL.
14. Patient with hepatitis B virus, hepatitis C virus, liver cirrhosis or portal hypertension, or is known to be human immunodeficiency virus (HIV) positive.
15. Patient with primary sclerosing cholangitis.
16. Patient with malignancy within the past 5 years, with the exception of completely excised squamous or basal cell skin cancers, and cervical carcinoma in situ.
17. Patient received cyclosporine, an anti-TNFα or other immunomodulatory agents other than azathioprine/6-mercaptopurine within 12 weeks prior to Screening.
18. Patient is a primary non-responder an anti-TNFα.
19. Patient is refractory to azathioprine/6-mercaptopurine.
20. Patient received methotrexate within 6 weeks prior to Screening.
21. Patient received metronidazole within 2 weeks prior to Screening.
22. Patient received non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350 mg/d which is allowed.
23. Patient received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period.
24. Patient with history of drug or alcohol abuse within 6 months prior to Screening.
25. Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
26. Patient is unable or unwilling to swallow study medication suspension.
27. Patient with a significant medical condition which puts the patient at risk for study participation and/or for any reason is considered by the Investigator to be an unsuitable patient to receive CNDO-201 TSO or is potentially put at risk by study procedures.
28. Patient who has participated in another clinical trial within 30 days of Screening for this trial and/or any experimental treatment for this population.
18 Years
65 Years
ALL
No
Sponsors
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Coronado Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nova Silver
Role: STUDY_DIRECTOR
Coronado Biosciences
Locations
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Visions Clinical Research - Tucson
Tucson, Arizona, United States
Lynn Institue of the Ozarks
Little Rock, Arkansas, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Rokay Kamyar, MD Inc
La Mesa, California, United States
Medvin Clinical Research
La Mirada, California, United States
Lakewood Primary Care Medical Group, Inc
Lakewood, California, United States
Alliance Research
Long Beach, California, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States
Alliance Clinical Research, LLC
Oceanside, California, United States
Digestive Care Associates
San Carlos, California, United States
San Diego Clinical Trials
San Diego, California, United States
Gastroenterology of the Rockies
Lafayette, Colorado, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Sanitas Research
Coral Gables, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Florida Medical Research Institute
Gainesville, Florida, United States
The Center for Gastrointestinal Disorders
Hollywood, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Gastroenterology Associates of Osceola
Kissimmee, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Paramount Public Health & Research Management Services
Miami, Florida, United States
Community Research Foundation, Inc
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States
Selah Medical Center
Boise, Idaho, United States
Northwest Gastroenterologists
Arlington Heights, Illinois, United States
Suburban Clinical Research
Bolingbrook, Illinois, United States
Suburban Clinical Research
Burr Ridge, Illinois, United States
The University of Chicago Hospital
Chicago, Illinois, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Cotton O'Neil Digestive Healthcare
Topeka, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Health Services
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Beyer Research
Kalamazoo, Michigan, United States
Midwest Center for Clinical Research
Lee's Summit, Missouri, United States
Center for Digestive and Liver Disease
Mexico, Missouri, United States
Billings Clinic Research Center
Billings, Montana, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Reno Clinical Trials
Sparks, Nevada, United States
South Jersey Medical Associates, P.A.
Blackwood, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Albany Medical Center
Albany, New York, United States
Digestive Health Physicians
Cheektowaga, New York, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Metropolitan Research Associates
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, United States
Consultants for Clinical Research, Inc
Cincinnati, Ohio, United States
The Ohio State University-Inflammatory Bowel Disease Ctr
Columbus, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, United States
Northwest Gastroenterology Clinic, LLD
Portland, Oregon, United States
James J. Boylan Gastroenterology and Liver Diseases
Bethlehem, Pennsylvania, United States
Shirish A. Amin, MD, PC
Indiana, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, United States
Cherry Tree Medical
Uniontown, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Gastroenterology PA/Professional Quality Research, Inc
Austin, Texas, United States
Lovelace Scientific Resources, Inc.
Austin, Texas, United States
Diagnostic Clinic of Houston
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Countries
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Other Identifiers
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CNDO 201-003
Identifier Type: -
Identifier Source: org_study_id
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