Clinical trial NCT01576471: Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: T. suis ova
Trichuris suis ova
Inflammatory Bowel Disease
TRUST-I
TRUSTI
TRUST-1
TRUST1
Lead sponsor: Coronado Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institue of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: La Mesa
country: United States
facility: Rokay Kamyar, MD Inc
state: California
city: La Mirada
country: United States
facility: Medvin Clinical Research
state: California
city: Lakewood
country: United States
facility: Lakewood Primary Care Medical Group, Inc
state: California
city: Long Beach
country: United States
facility: Alliance Research
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research, LLC
state: California
city: San Carlos
country: United States
facility: Digestive Care Associates
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Lafayette
country: United States
facility: Gastroenterology of the Rockies
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Coral Gables
country: United States
facility: Sanitas Research
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Hollywood
country: United States
facility: The Center for Gastrointestinal Disorders
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Kissimmee
country: United States
facility: Gastroenterology Associates of Osceola
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Miami
country: United States
facility: Paramount Public Health & Research Management Services
state: Florida
city: Miami
country: United States
facility: Community Research Foundation, Inc
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Boise
country: United States
facility: Selah Medical Center
state: Idaho
city: Arlington Heights
country: United States
facility: Northwest Gastroenterologists
state: Illinois
city: Bolingbrook
country: United States
facility: Suburban Clinical Research
state: Illinois
city: Burr Ridge
country: United States
facility: Suburban Clinical Research
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Hospital
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Healthcare
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health Services
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Lee's Summit
country: United States
facility: Midwest Center for Clinical Research
state: Missouri
city: Mexico
country: United States
facility: Center for Digestive and Liver Disease
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Center
state: Montana
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Sparks
country: United States
facility: Reno Clinical Trials
state: Nevada
city: Blackwood
country: United States
facility: South Jersey Medical Associates, P.A.
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Cheektowaga
country: United States
facility: Digestive Health Physicians
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: New York
country: United States
facility: Metropolitan Research Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research, Inc
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University-Inflammatory Bowel Disease Ctr
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Tulsa
country: United States
facility: Gastroenterology United of Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic, LLD
state: Oregon
city: Bethlehem
country: United States
facility: James J. Boylan Gastroenterology and Liver Diseases
state: Pennsylvania
city: Indiana
country: United States
facility: Shirish A. Amin, MD, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education & Research
state: Pennsylvania
city: Uniontown
country: United States
facility: Cherry Tree Medical
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology PA/Professional Quality Research, Inc
state: Texas
city: Austin
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Texas
city: Houston
country: United States
facility: Diagnostic Clinic of Houston
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Fairfax
country: United States
facility: Gastroenterology Associates of Northern Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
Study officials:
affiliation: Coronado Biosciences
name: Nova Silver
role: STUDY_DIRECTOR
References: