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

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 monthsconfirmed by endoscopic and histological, or endoscopic and radiological criteria.

3. Patient with localization of CD either in terminal ileum (L1), in colon (L2) orileocolitis (L3), all without upper gastrointestinal involvement (- L4) according tothe 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 weeksprior to Baseline.

6. Patient is not using concomitant medication for treatment of underlying Crohn'sdisease with the following exceptions: concomitant medications may include: 1) Oral orrectal sulfasalazine, mesalazine (5-ASA), or mesalazine derivative, if receiving itfor >6 weeks and if receiving the same dose for at least 4 weeks; 2) Oral prednisoneup to 15 mg/day, or budesonide if receiving it for >4 weeks and if receiving the samedose 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 receivingthe 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 > lowerlimit of normal at screening.

8. For females of childbearing potential, negative serum pregnancy test prior toenrollment, not breastfeeding for study duration, and willingness to use acceptedforms of reliable birth control for study duration [including bilateral tuballigation, use of oral contraceptives, double barrier methods (diaphragm withspermicidal gel or condoms with contraceptive foam), Depo-Provera®, hormonal implants,and total abstinence]. Pregnancy tests are not required (indicate "N/A") for males orfemales not of childbearing potential (post-menopausal with last menstrual period >1year 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 oftoxicity (sepsis), has symptomatic strictures, or impending obstruction oranticipating a need for blood transfusion for gastrointestinal bleeding or in whomsurgical 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 tosevere local inflammation.

9. Patient with history of colorectal cancer or colorectal dysplasia. Patients withcompletely 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 orparasites at Screening.

12. Female patient who is pregnant or breastfeeding or wishing to become pregnant duringstudy participation or unwilling to use birth control.

13. Patient with serum creatinine ≥ 2.0 mg/dL; blood urea nitrogen >40 mg/dL; alkalinephosphatase > 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 portalhypertension, 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 completelyexcised squamous or basal cell skin cancers, and cervical carcinoma in situ.

17. Patient received cyclosporine, an anti-TNFα or other immunomodulatory agents otherthan 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 beforeBaseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350mg/d which is allowed.

23. Patient received antibiotic, antifungal or antiparasitic medication in the last 2weeks prior to Screening and/or would potentially require this during the studytreatment 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 includingdiet 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 studyparticipation and/or for any reason is considered by the Investigator to be anunsuitable patient to receive CNDO-201 TSO or is potentially put at risk by studyprocedures.

28. Patient who has participated in another clinical trial within 30 days of Screening forthis trial and/or any experimental treatment for this population.