EUCTR2006-000720-13-AT
Active, not recruiting
Not Applicable
Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Induction of remission in active Crohn´s disease
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent,
- •2\. Man or woman between 18 and 75 years of age,
- •3\. Established diagnosis of Crohn's disease (CD) confirmed by endoscopic and histological, or endoscopic and radiological criteria, all of which since at least 3 months prior to screening,
- •4\. Localisation 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\),
- •5\. CDAI \=220 and \= 350 at baseline,
- •6\. Serum CRP level \= 2 x upper limit of normal (ULN) or stool Calprotectin \> ULN at screening,
- •7\. Haemoglobin \= 10 g/dl at screening,
- •8\. White blood cell count \= 13\.0 Gpt/L at screening,
- •9\. Platelet count \= lower limit of normal at screening,
- •10\. Negative pregnancy test in females of childbearing potential,
Exclusion Criteria
- •1\. Known Crohn's lesions in the upper GI\-tract (up to and including the jejunum) with present symptoms,
- •2\. Bowel surgery within the last 3 months prior to baseline,
- •3\. Resection of more than 50 cm of the ileum,
- •4\. Ileostomy or colostomy,
- •5\. Septic complications,
- •6\. Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture),
- •7\. Abscess, perforation, active fistulas, or active perianal lesions,
- •8\. Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
- •9\. Clinical signs of stricturing disease,
- •10\. Parenteral or tube feeding,
Outcomes
Primary Outcomes
Not specified
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