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Crohn's DiseasePhase 2TRUST-INCT01576471

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

A Phase 2 study testing Trichuris suis ova (TSO) in people with Crohn's Disease, run by Coronado Biosciences, Inc. at 73 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Crohn's Disease
What is being tested?
Trichuris suis ova (TSO)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
73 sitesUnited States
Study dates
Jul 2012to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.
  • 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.
  • Patient received cyclosporine, an anti-TNFα or other immunomodulatory agents other than azathioprine/6-mercaptopurine within 12 weeks prior to Screening.
  • Patient is a primary non-responder an anti-TNFα.
  • Patient is refractory to azathioprine/6-mercaptopurine.
  • Patient received methotrexate within 6 weeks prior to Screening.
  • Patient received metronidazole within 2 weeks prior to Screening.
  • 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.
  • 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.
  • Patient with history of drug or alcohol abuse within 6 months prior to Screening.
  • Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
  • Patient is unable or unwilling to swallow study medication suspension.
  • 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.
  • Patient who has participated in another clinical trial within 30 days of Screening for this trial and/or any experimental treatment for this population.

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • University of Michigan Health Services

    Ann Arbor, Michigan, 48109

  • Northwest Gastroenterologists

    Arlington Heights, Illinois, 60005

  • Austin Gastroenterology PA/Professional Quality Research, Inc

    Austin, Texas, 78705

  • Lovelace Scientific Resources, Inc.

    Austin, Texas, 78758

  • James J. Boylan Gastroenterology and Liver Diseases

    Bethlehem, Pennsylvania, 18015

  • Billings Clinic Research Center

    Billings, Montana, 59101

  • South Jersey Medical Associates, P.A.

    Blackwood, New Jersey, 08012

  • Selah Medical Center

    Boise, Idaho, 83704

  • Suburban Clinical Research

    Bolingbrook, Illinois, 60490

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Suburban Clinical Research

    Burr Ridge, Illinois, 60527

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Digestive Health Physicians

    Cheektowaga, New York, 14225

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • The University of Chicago Hospital

    Chicago, Illinois, 60637

  • Consultants for Clinical Research, Inc

    Cincinnati, Ohio, 45219

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • The Ohio State University-Inflammatory Bowel Disease Ctr

    Columbus, Ohio, 43210

  • Sanitas Research

    Coral Gables, Florida, 33134

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Medisphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Florida Medical Research Institute

    Gainesville, Florida, 32607

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • The Center for Gastrointestinal Disorders

    Hollywood, Florida, 33021

  • Diagnostic Clinic of Houston

    Houston, Texas, 77004

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Shirish A. Amin, MD, PC

    Indiana, Pennsylvania, 15701

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Borland-Groover Clinic

    Jacksonville, Florida, 32204

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Gastroenterology Associates of Osceola

    Kissimmee, Florida, 34741

  • Rokay Kamyar, MD Inc

    La Mesa, California, 91941

  • Medvin Clinical Research

    La Mirada, California, 90638

  • Gastroenterology of the Rockies

    Lafayette, Colorado, 80026

  • Lakewood Primary Care Medical Group, Inc

    Lakewood, California, 90712

  • Sunrise Medical Research

    Lauderdale Lakes, Florida, 33319

  • Midwest Center for Clinical Research

    Lee's Summit, Missouri, 64064

  • Lynn Institue of the Ozarks

    Little Rock, Arkansas, 72205

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Alliance Research

    Long Beach, California, 90804

  • Collaborative Neuroscience Network, Inc.

    Long Beach, California, 90806

  • University of Louisville

    Louisville, Kentucky, 40202

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Center for Digestive and Liver Disease

    Mexico, Missouri, 65265

  • Paramount Public Health & Research Management Services

    Miami, Florida, 33135

  • Community Research Foundation, Inc

    Miami, Florida, 33155

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Metropolitan Research Associates

    New York, New York, 10016

  • Alliance Clinical Research, LLC

    Oceanside, California, 92056

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Northwest Gastroenterology Clinic, LLD

    Portland, Oregon, 97210

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • Digestive Care Associates

    San Carlos, California, 94070

  • San Diego Clinical Trials

    San Diego, California, 92120

  • Donald Guthrie Foundation for Education & Research

    Sayre, Pennsylvania, 18840

  • Reno Clinical Trials

    Sparks, Nevada, 89434

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 336003

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Cotton O'Neil Digestive Healthcare

    Topeka, Kansas, 66606

  • Visions Clinical Research - Tucson

    Tucson, Arizona, 85712

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma, 74135

  • Cherry Tree Medical

    Uniontown, Pennsylvania, 15401

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Clinical Trials of America, Inc.

    Winston-Salem, North Carolina, 27103

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

About this study

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

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
Being tested
Trichuris suis ova (TSO), Placebo
Keywords
T. suis ova, Trichuris suis ova, Inflammatory Bowel Disease, TRUST-I, TRUSTI, TRUST-1, TRUST1
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trichuris suis ova (TSO)Biological

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

  • PlaceboBiological

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

Study groups in NCT01576471
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo
TSO 7500ExperimentalNot described
Receives: Biological: Trichuris suis ova (TSO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2013
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01576471
Sponsor's protocol ID
CNDO 201-003
Acronym
TRUST-I
Status last verified
Apr 2017
First submitted
10 Apr 2012
Last updated
29 Jun 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trichuris suis ova (TSO) in people with Crohn's Disease, run by Coronado Biosciences, Inc. at 73 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01576471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.

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