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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01576471
• Date of registration: 10/04/2012
• Prospective Registration: Yes
• Primary sponsor: Coronado Biosciences, Inc.
• Public title: Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo TRUST-I
• Scientific 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
• Date of first enrolment: July 2012
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01576471
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Nova Silver
• Affiliation: Coronado Biosciences

Key inclusion & exclusion 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-TNFa or other immunomodulatory agents other
than azathioprine/6-mercaptopurine within 12 weeks prior to Screening.

18. Patient is a primary non-responder an anti-TNFa.

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Placebo

Biological: Trichuris suis ova (TSO)

Primary Outcome(s)

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]

Secondary ID(s)

CNDO 201-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01576471