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

Phase 2

Completed

• Conditions: Crohn´s Disease
• Interventions: Drug: Medium dose TSO; Drug: Low dose TSO; Drug: High dose TSO; Drug: Placebo

• Registration Number: NCT01279577
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium dose TSO	Medium dose TSO	Medium dose suspension of TSO
Low dose TSO	Low dose TSO	Low dose suspension of TSO
High dose TSO	High dose TSO	High dose suspension of TSO
Placebo	Placebo	Placebo solution

Primary Outcome Measures

Name	Time	Method
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150	12 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction of > 100 points in CDAI	12 weeks
Adverse events	12 weeks

Trial Locations

Locations (1)

Klinikum der Johann Wolfgang Goethe-Universität; 🇩🇪 Frankfurt a.M., Hessen, Germany