NCT01434693

Brief Summary

This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and 7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo), double-blind, placebo-controlled study to evaluate the safety of a single dose of oral CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's Disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 20, 2013

Completed
Last Updated

May 20, 2013

Status Verified

April 1, 2013

Enrollment Period

5 months

First QC Date

September 13, 2011

Results QC Date

February 26, 2013

Last Update Submit

May 17, 2013

Conditions

Crohn's Disease

Keywords

T. suis ovaCrohn's disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms

    6 mo

Study Arms (4)

TSO 500

EXPERIMENTAL
Biological: Trichuris suis ova

TSO 2500

EXPERIMENTAL
Biological: Trichuris suis ova

TSO 7500

EXPERIMENTAL
Biological: Trichuris suis ova

Placebo

PLACEBO COMPARATOR

single dose

Other: Placebo

Interventions

Trichuris suis ovaBIOLOGICAL

single dose

TSO 2500TSO 500TSO 7500
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males or females, 18 to 55 years old.
  • Patient has confirmed diagnosis of Crohn's Disease by established criteria with a minimum disease duration of 3 months.
  • If patient is using concomitant medications, the dose/regimen is stable and remains stable for the two weeks of close observation following TSO administration. Concomitant medications may include: 1) Oral 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, if receiving it for \>4 weeks and if receiving the same dose for at least 2 weeks; and 3) Azathioprine or 6-mercaptopurine if receiving it for \>3 months and if receiving the same dose for at least 8 weeks.
  • Hemoglobin ≥ 12 g/dL at screening.
  • Normal white blood cell count and normal lymphocyte count at screening.
  • Platelet count \> lower limit of normal at screening.
  • For females of childbearing potential, negative serum pregnancy test during the screening period, not breastfeeding for study duration, and willingness to use accepted forms of reliable birth control for study duration \[including bilateral tubal ligation, use of oral contraceptives, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence\]. 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 must have the ability to provide informed consent.

You may not qualify if:

  • Patient with ulcerative colitis, indeterminate colitis, or ulcerative proctitis.
  • Bowel surgery in past 6 months.
  • Resection of more than 50 cm of the ileum.
  • Ileostomy colostomy.
  • Septic complications.
  • Patient who is hospitalized or exhibiting signs of toxicity (sepsis), has significant or multiple strictures, or impending obstruction (as evidenced by abdominal distension, severe abdominal tenderness, fever, nausea, vomiting, or tachycardia) or anticipating a need for blood transfusion for gastrointestinal bleeding or in whom surgical intervention may be imminent.
  • Patient with gastrointestinal abscess, perforation, active draining fistulae or fistulae that are considered clinically significant or perianal lesions.
  • Patient with history of colorectal cancer or colorectal dysplasia.
  • Parenteral or tube feeding.
  • Patient with 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 active hepatitis B virus, hepatitis C virus, liver cirrhosis or portal hypertension, cytomegalovirus, Epstein Barr Virus or herpes simplex virus or is known to be human immunodeficiency virus (HIV) positive.
  • Patient with primary sclerosing cholangitis.
  • Patient with active malignancy or treatment with anticancer drugs in the past 5 years.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Midwest Center for Clinical Research

Lee's Summit, Missouri, 64064, United States

Location

Center for Digestive & Liver Diseases, Inc

Mexico, Missouri, 65265, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Vice President Clinical Operations
Organization
Coronado Biosciences
nsilver@coronadobio.com
781.652.4516

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
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

September 13, 2011

First Posted

September 15, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

September 1, 2012

Last Updated

May 20, 2013

Results First Posted

May 20, 2013

Record last verified: 2013-04

Locations

US(7)