Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo (TRUST-I)

A Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment With Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients With Moderately to Severely Active Crohn's Disease

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Placebo; Biological: Trichuris suis ova (TSO)

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research - Tucson
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institue of the Ozarks
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
    • La Mesa, California, United States, 91941
      • Rokay Kamyar, MD Inc
    • La Mirada, California, United States, 90638
      • Medvin Clinical Research
    • Lakewood, California, United States, 90712
      • Lakewood Primary Care Medical Group, Inc
    • Long Beach, California, United States, 90804
      • Alliance Research
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, Inc.
    • Oceanside, California, United States, 92056
      • Alliance Clinical Research, LLC
    • San Carlos, California, United States, 94070
      • Digestive Care Associates
    • San Diego, California, United States, 92120
      • San Diego Clinical Trials
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Gastroenterology of the Rockies
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Coral Gables, Florida, United States, 33134
      • Sanitas Research
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Gainesville, Florida, United States, 32607
      • Florida Medical Research Institute
    • Hollywood, Florida, United States, 33021
      • The Center for Gastrointestinal Disorders
    • Jacksonville, Florida, United States, 32204
      • Borland-Groover Clinic
    • Kissimmee, Florida, United States, 34741
      • Gastroenterology Associates of Osceola
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research
    • Miami, Florida, United States, 33135
      • Paramount Public Health & Research Management Services
    • Miami, Florida, United States, 33155
      • Community Research Foundation, Inc
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Tampa, Florida, United States, 336003
      • Clinical Research of West Florida, Inc.
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
  • Georgia
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Specialists, PC
  • Idaho
    • Boise, Idaho, United States, 83704
      • Selah Medical Center
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Gastroenterologists
    • Bolingbrook, Illinois, United States, 60490
      • Suburban Clinical Research
    • Burr Ridge, Illinois, United States, 60527
      • Suburban Clinical Research
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Hospital
  • Indiana
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Digestive Healthcare
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health Services
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
  • Missouri
    • Lee's Summit, Missouri, United States, 64064
      • Midwest Center For Clinical Research
    • Mexico, Missouri, United States, 65265
      • Center for Digestive and Liver Disease
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Research Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
  • Nevada
    • Sparks, Nevada, United States, 89434
      • Reno Clinical Trials
  • New Jersey
    • Blackwood, New Jersey, United States, 08012
      • South Jersey Medical Associates, P.A.
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Cheektowaga, New York, United States, 14225
      • Digestive Health Physicians
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates, LLP
    • New York, New York, United States, 10016
      • Metropolitan Research Associates
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Clinical Trials of America, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research, Inc
    • Columbus, Ohio, United States, 43210
      • The Ohio State University-Inflammatory Bowel Disease Ctr
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • Gastroenterology United of Tulsa
  • Oregon
    • Portland, Oregon, United States, 97210
      • Northwest Gastroenterology Clinic, LLD
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • James J. Boylan Gastroenterology and Liver Diseases
    • Indiana, Pennsylvania, United States, 15701
      • Shirish A. Amin, MD, PC
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation for Education & Research
    • Uniontown, Pennsylvania, United States, 15401
      • Cherry Tree Medical
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Gastroenterology PA/Professional Quality Research, Inc
    • Austin, Texas, United States, 78758
      • Lovelace Scientific Resources, Inc.
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77004
      • Diagnostic Clinic of Houston
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Gastroenterology Associates of Northern Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Medical Center
  • Washington
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is male or female, 18 to 65 years old.
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:

1. Patient with known Crohn's lesions in the upper GI-tract (esophagus, stomach, duodenum, jejunum) with present symptoms.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
Experimental: TSO 7500	Biological: Trichuris suis ova (TSO); TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Coronado Biosciences, Inc.
• Investigators: Study Director: Nova Silver, Coronado Biosciences

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (Estimate): April 12, 2012

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Trichuris suis ova; T. suis ova; Inflammatory Bowel Disease; TRUST-I; TRUSTI; TRUST-1; TRUST1
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: CNDO 201-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No