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

Crohn's Disease Clinical Trial

— TRUST-I  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01576471
• Other study ID #: CNDO 201-003
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 10, 2012
• Last updated: May 17, 2013
• Start date: July 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2013
• Source: Coronado Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: October 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-TNFa or other immunomodulatory agents other than azathioprine/6-mercaptopurine within 12 weeks prior to Screening.

18. Patient is a primary non-responder an anti-TNFa.

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• 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)

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Anaheim Clinical Trials	Anaheim	California
United States	University of Michigan Health Services	Ann Arbor	Michigan
United States	Northwest Gastroenterologists	Arlington Heights	Illinois
United States	Austin Gastroenterology PA/Professional Quality Research, Inc	Austin	Texas
United States	Lovelace Scientific Resources, Inc.	Austin	Texas
United States	James J. Boylan Gastroenterology and Liver Diseases	Bethlehem	Pennsylvania
United States	Billings Clinic Research Center	Billings	Montana
United States	South Jersey Medical Associates, P.A.	Blackwood	New Jersey
United States	Selah Medical Center	Boise	Idaho
United States	Suburban Clinical Research	Bolingbrook	Illinois
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Suburban Clinical Research	Burr Ridge	Illinois
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Digestive Health Physicians	Cheektowaga	New York
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	The University of Chicago Hospital	Chicago	Illinois
United States	Consultants for Clinical Research, Inc	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	The Ohio State University-Inflammatory Bowel Disease Ctr	Columbus	Ohio
United States	Sanitas Research	Coral Gables	Florida
United States	Avail Clinical Research, LLC	Deland	Florida
United States	Medisphere Medical Research Center, LLC	Evansville	Indiana
United States	Gastroenterology Associates of Northern Virginia	Fairfax	Virginia
United States	Florida Medical Research Institute	Gainesville	Florida
United States	Long Island Clinical Research Associates, LLP	Great Neck	New York
United States	The Center for Gastrointestinal Disorders	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Diagnostic Clinic of Houston	Houston	Texas
United States	Shirish A. Amin, MD, PC	Indiana	Pennsylvania
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Beyer Research	Kalamazoo	Michigan
United States	Gastroenterology Associates of Osceola	Kissimme	Florida
United States	Rokay Kamyar, MD Inc	La Mesa	California
United States	Medvin Clinical Research	La Mirada	California
United States	Gastroenterology of the Rockies	Lafayette	Colorado
United States	Lakewood Primary Care Medical Group, Inc	Lakewood	California
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	Midwest Center for Clinical Research	Lee's Summit	Missouri
United States	Lynn Institue of the Ozarks	Little Rock	Arkansas
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Alliance Research	Long Beach	California
United States	Collaborative Neuroscience Network, Inc.	Long Beach	California
United States	University of Louisville	Louisville	Kentucky
United States	Great Lakes Gastroenterology	Mentor	Ohio
United States	Center for Digestive and Liver Disease	Mexico	Missouri
United States	Community Research Foundation, Inc	Miami	Florida
United States	Paramount Public Health & Research Management Services	Miami	Florida
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Metropolitan Research Associates	New York	New York
United States	Alliance Clinical Research, LLC	Oceanside	California
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Northwest Gastroenterology Clinic, LLD	Portland	Oregon
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Digestive Care Associates	San Carlos	California
United States	San Diego Clinical Trials	San Diego	California
United States	Donald Guthrie Foundation for Education & Research	Sayre	Pennsylvania
United States	Reno Clinical Trials	Sparks	Nevada
United States	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Cotton O'Neil Digestive Healthcare	Topeka	Kansas
United States	Visions Clinical Research - Tucson	Tucson	Arizona
United States	Gastroenterology United of Tulsa	Tulsa	Oklahoma
United States	Cherry Tree Medical	Uniontown	Pennsylvania
United States	Omega Medical Research	Warwick	Rhode Island
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Clinical Trials of America, Inc.	Winston-Salem	North Carolina
United States	Shafran Gastroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Coronado Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)		12 weeks	Yes