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

NCT01576471 | Completed Phase 2 Results DMC

• 1 other identifier: CNDO 201-003
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 73

Brief 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.

Conditions

Crohn's Disease

Keywords

T. suis ova; Trichuris suis ova; Inflammatory Bowel Disease; TRUST-I; TRUSTI; TRUST-1; TRUST1

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Biological: Placebo

TSO 7500

EXPERIMENTAL

Biological: Trichuris suis ova (TSO)

Interventions

Trichuris suis ova (TSO) BIOLOGICAL

TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)

TSO 7500

Placebo BIOLOGICAL

Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male or female, 18 to 65 years old.
• Patient with established diagnosis of Crohn's disease (CD) for at least 3 months confirmed by endoscopic and histological, or endoscopic and radiological criteria.
• 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).
• Patient with active, symptomatic CD manifested by CDAI ≥ 220 and ≤ 450 at Baseline.
• Patient with active intestinal inflammation as visualized by endoscopy within 8 weeks prior to Baseline.
• 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.
• Hemoglobin of at least 10 g/dl, normal white blood cell and platelet count \> lower limit of normal at screening.
• 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).
• Patient has the ability to provide informed consent.

You may not qualify if:

• Patient with known Crohn's lesions in the upper GI-tract (esophagus, stomach, duodenum, jejunum) with present symptoms.
• Patient with ulcerative colitis, indeterminate colitis, or ulcerative proctitis.
• Bowel surgery in past 6 months prior to Screening.
• Resection of more than 50 cm of the ileum.
• Current ileostomy or colostomy.
• 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.
• Patient with gastrointestinal abscess or perforation.
• Patient with fistulae having a new onset within 2 months of Screening with moderate to severe local inflammation.
• Patient with history of colorectal cancer or colorectal dysplasia. Patients with completely resected sporadic adenomas may be enrolled.
• Patient requiring parenteral or tube feeding.
• 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.
• Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
• 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.
• Patient with hepatitis B virus, hepatitis C virus, liver cirrhosis or portal hypertension, or is known to be human immunodeficiency virus (HIV) positive.
• Patient with primary sclerosing cholangitis.

Sponsors & Collaborators

• Coronado Biosciences, Inc.: lead

Study Sites (73)

Visions Clinical Research - Tucson

Tucson, Arizona, 85712, United States

Location

Lynn Institue of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Rokay Kamyar, MD Inc

La Mesa, California, 91941, United States

Location

Medvin Clinical Research

La Mirada, California, 90638, United States

Location

Lakewood Primary Care Medical Group, Inc

Lakewood, California, 90712, United States

Location

Alliance Research

Long Beach, California, 90804, United States

Location

Collaborative Neuroscience Network, Inc.

Long Beach, California, 90806, United States

Location

Alliance Clinical Research, LLC

Oceanside, California, 92056, United States

Location

Digestive Care Associates

San Carlos, California, 94070, United States

Location

San Diego Clinical Trials

San Diego, California, 92120, United States

Location

Gastroenterology of the Rockies

Lafayette, Colorado, 80026, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Sanitas Research

Coral Gables, Florida, 33134, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Florida Medical Research Institute

Gainesville, Florida, 32607, United States

Location

The Center for Gastrointestinal Disorders

Hollywood, Florida, 33021, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32204, United States

Location

Gastroenterology Associates of Osceola

Kissimmee, Florida, 34741, United States

Location

Sunrise Medical Research

Lauderdale Lakes, Florida, 33319, United States

Location

Paramount Public Health & Research Management Services

Miami, Florida, 33135, United States

Location

Community Research Foundation, Inc

Miami, Florida, 33155, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 336003, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, 30024, United States

Location

Selah Medical Center

Boise, Idaho, 83704, United States

Location

Northwest Gastroenterologists

Arlington Heights, Illinois, 60005, United States

Location

Suburban Clinical Research

Bolingbrook, Illinois, 60490, United States

Location

Suburban Clinical Research

Burr Ridge, Illinois, 60527, United States

Location

The University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Medisphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cotton O'Neil Digestive Healthcare

Topeka, Kansas, 66606, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health Services

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

Midwest Center for Clinical Research

Lee's Summit, Missouri, 64064, United States

Location

Center for Digestive and Liver Disease

Mexico, Missouri, 65265, United States

Location

Billings Clinic Research Center

Billings, Montana, 59101, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Reno Clinical Trials

Sparks, Nevada, 89434, United States

Location

South Jersey Medical Associates, P.A.

Blackwood, New Jersey, 08012, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Digestive Health Physicians

Cheektowaga, New York, 14225, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

Metropolitan Research Associates

New York, New York, 10016, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Clinical Trials of America, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Consultants for Clinical Research, Inc

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University-Inflammatory Bowel Disease Ctr

Columbus, Ohio, 43210, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Gastroenterology United of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

Northwest Gastroenterology Clinic, LLD

Portland, Oregon, 97210, United States

Location

James J. Boylan Gastroenterology and Liver Diseases

Bethlehem, Pennsylvania, 18015, United States

Location

Shirish A. Amin, MD, PC

Indiana, Pennsylvania, 15701, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Donald Guthrie Foundation for Education & Research

Sayre, Pennsylvania, 18840, United States

Location

Cherry Tree Medical

Uniontown, Pennsylvania, 15401, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Austin Gastroenterology PA/Professional Quality Research, Inc

Austin, Texas, 78705, United States

Location

Lovelace Scientific Resources, Inc.

Austin, Texas, 78758, United States

Location

Diagnostic Clinic of Houston

Houston, Texas, 77004, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: Coronado Biosciences

nsilver@coronadobio.com

7816524516

Study Officials

• Nova Silver

  Coronado Biosciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-04

Locations

US (73)