Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease - Full Text View

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Genetic and Rare Diseases Information Center resources: Trichuriasis

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 ]


Enrollment:	254
Study Start Date:	November 2010
Study Completion Date:	February 2014
Primary Completion Date:	February 2014 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279577

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
Study First Received:	January 18, 2011
Last Updated:	February 9, 2015
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 September 30, 2016

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