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

This study is currently recruiting participants.
Verified July 2012 by Dr. Falk Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01279577
First received: January 18, 2011
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn´s Disease
 Drug: Low dose TSO
Drug: Medium dose TSO
Drug: High dose TSO
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of > 100 points in CDAI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 212
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose TSO
Low dose suspension of TSO
 Drug: Low dose TSO
Low dose TSO suspension
Experimental: Medium dose TSO
Medium dose suspension of TSO
 Drug: Medium dose TSO
Medium dose TSO suspension
Experimental: High dose TSO
High dose suspension of TSO
 Drug: High dose TSO
High dose TSO suspension
Placebo Comparator: Placebo
Placebo solution
 Drug: Placebo
Placebo solution

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279577

Contacts
Contact: Ralph Müller, Dr ++49-761-1514 ext 0 mueller@drfalkpharma.de

Locations
Germany
Klinikum der Johann Wolfgang Goethe-Universität Recruiting
Frankfurt a.M., Hessen, Germany, 60590
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Jürgen Schölmerich, Prof. Klinikum der Johann Wolfgang Goethe-Universität
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01279577     History of Changes
Other Study ID Numbers: TSU-2/CDA, 2006-000720-13
Study First Received: January 18, 2011
Last Updated: July 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:
Crohn´s disease
Trichuris suis
randomized
 placebo
induction of remission
porcine whipworm

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 19, 2013