Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.

This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH

Criteria

Major Inclusion Criteria:

• Signed informed consent,

• Man or woman between 18 and 75 years of age,

• Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria,

• Negative pregnancy test in females of childbearing potential.

Major Exclusion Criteria:

• Bowel surgery within the last 3 months prior to baseline,

• Resection of more than 50 cm of the ileum,

• Ileostomy or colostomy,

• Septic complications,

• Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture),

• Abscess, perforation, fistulas, or perianal lesions,

• Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),

• Clinical signs of stricturing disease,

• Parenteral or tube feeding,

• Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN] at screening), liver cirrhosis, or portal hypertension,

• Abnormal renal function (Cystatin C > ULN) at screening,

• Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results,

• Any condition associated with significant immunosuppression,

• Active malignancy or treatment with anticancer drugs during the last 5 years.

• Existing or intended pregnancy or breast-feeding,

• Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.