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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn´s Disease	Drug: Low dose TSO; Drug: Medium dose TSO; Drug: High dose TSO; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 254 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: November 2010
• Actual Primary Completion Date: February 2014
• Actual Study Completion Date: February 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Germany

Klinikum der Johann Wolfgang Goethe-Universität

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

• Responsible Party: Dr. Falk Pharma GmbH
• ClinicalTrials.gov Identifier: NCT01279577 History of Changes
• Other Study ID Numbers: TSU-2/CDA; 2006-000720-13 ( EudraCT Number )
• First Posted: January 19, 2011
• Last Update Posted: February 10, 2015
• Last Verified: February 2015

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