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Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease (TRUST-2)

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ClinicalTrials.gov Identifier: NCT01279577
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Tracking Information
First Submitted Date  ICMJE January 18, 2011
First Posted Date  ICMJE January 19, 2011
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
  • Reduction of > 100 points in CDAI [ Time Frame: 12 weeks ]
  • Adverse events [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn´s Disease
Intervention  ICMJE
  • Drug: Low dose TSO
    Low dose TSO suspension
  • Drug: Medium dose TSO
    Medium dose TSO suspension
  • Drug: High dose TSO
    High dose TSO suspension
  • Drug: Placebo
    Placebo solution
Study Arms  ICMJE
  • Experimental: Low dose TSO
    Low dose suspension of TSO
    Intervention: Drug: Low dose TSO
  • Experimental: Medium dose TSO
    Medium dose suspension of TSO
    Intervention: Drug: Medium dose TSO
  • Experimental: High dose TSO
    High dose suspension of TSO
    Intervention: Drug: High dose TSO
  • Placebo Comparator: Placebo
    Placebo solution
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2011)
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01279577
Other Study ID Numbers  ICMJE TSU-2/CDA
2006-000720-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Falk Pharma GmbH
Original Responsible Party Dr. Ralph Müller, Project Manager Clinical Research, Dr. Falk Pharma GmbH
Current Study Sponsor  ICMJE Dr. Falk Pharma GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jürgen Schölmerich, Prof. Klinikum der Johann Wolfgang Goethe-Universität
PRS Account Dr. Falk Pharma GmbH
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP