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

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

Tracking Information

• First Submitted Date: January 18, 2011
• First Posted Date: January 19, 2011
• Last Update Posted Date: February 10, 2015
• Study Start Date: November 2010
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (submitted: January 18, 2011)

• Reduction of > 100 points in CDAI [ Time Frame: 12 weeks ]
• Adverse events [ Time Frame: 12 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease
• 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Crohn´s Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2015): 254
• Original Estimated Enrollment (submitted: January 18, 2011): 212
• Actual Study Completion Date: February 2014
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01279577
• Other Study ID Numbers: TSU-2/CDA; 2006-000720-13 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Dr. Falk Pharma GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jürgen Schölmerich, Prof.; Klinikum der Johann Wolfgang Goethe-Universität

• PRS Account: Dr. Falk Pharma GmbH
• Verification Date: February 2015