Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease

A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's Disease

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Placebo; Biological: Trichuris suis ova

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
  • Missouri
    • Lee's Summit, Missouri, United States, 64064
      • Midwest Center For Clinical Research
    • Mexico, Missouri, United States, 65265
      • Center for Digestive & Liver Diseases, Inc
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates, LLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females, 18 to 55 years old.
2. Patient has confirmed diagnosis of Crohn's Disease by established criteria with a minimum disease duration of 3 months.
3. 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.
4. Hemoglobin ≥ 12 g/dL at screening.
5. Normal white blood cell count and normal lymphocyte count at screening.
6. Platelet count > lower limit of normal at screening.
7. 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).
8. Patient must have the ability to provide informed consent.

Exclusion Criteria:

1. Patient with ulcerative colitis, indeterminate colitis, or ulcerative proctitis.
2. Bowel surgery in past 6 months.
3. Resection of more than 50 cm of the ileum.
4. Ileostomy colostomy.
5. Septic complications.
6. 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.
7. Patient with gastrointestinal abscess, perforation, active draining fistulae or fistulae that are considered clinically significant or perianal lesions.
8. Patient with history of colorectal cancer or colorectal dysplasia.
9. Parenteral or tube feeding.
10. 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.
11. Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
12. 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.
13. Patient with white blood count <5,000 or >15,000/mm3; platelet count <150,000 per μl; or iron or vitamin B12 deficiency. Correction of lab exclusion is allowed provided that medical condition is not deemed to put patient at risk and stability of result is sustained for a minimum of 30 days.
14. 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.
15. Patient with primary sclerosing cholangitis.
16. Patient with active malignancy or treatment with anticancer drugs in the past 5 years.
17. Patient received cyclosporine, anti-TNF or other immunomodulatory agents other than azathioprine/6-mercaptopurine 12 weeks prior to Screening.
18. Patient received methotrexate 4 weeks prior to Screening.
19. Patient received metronidazole 2 weeks prior to Screening.
20. 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.
21. 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.
22. Patient with history of drug or alcohol abuse within 6 months prior to Screening.
23. Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
24. Patient is unable or unwilling to swallow study medication suspension.
25. 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 candidate to receive CNDO-201 TSO or is potentially put at risk by study procedures.
26. Patients who has participated in another clinical trial within 30 days of Screening for this trial and/or any experimental treatment for this population.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TSO 7500	Biological: Trichuris suis ova; single dose
Experimental: TSO 500	Biological: Trichuris suis ova; single dose
Experimental: TSO 2500	Biological: Trichuris suis ova; single dose
Placebo Comparator: Placebo; single dose	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coronado Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2013
• Last Update Submitted That Met QC Criteria: May 17, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: T. suis ova; Crohn's disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: CNDO 201-002