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

Inclusion criteria

• 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.
• 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.

Exclusion criteria

• 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.
• 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.