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

NCT ID: NCT01279577

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Crohn´s Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose TSO

Low dose suspension of TSO

Group Type: EXPERIMENTAL

Low dose TSO

Intervention Type: DRUG

Low dose TSO suspension

Medium dose TSO

Medium dose suspension of TSO

Group Type: EXPERIMENTAL

Medium dose TSO

Intervention Type: DRUG

Medium dose TSO suspension

High dose TSO

High dose suspension of TSO

Group Type: EXPERIMENTAL

High dose TSO

Intervention Type: DRUG

High dose TSO suspension

Placebo

Placebo solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo solution

Interventions

Low dose TSO

Low dose TSO suspension

Intervention Type: DRUG

Medium dose TSO

Medium dose TSO suspension

Intervention Type: DRUG

High dose TSO

High dose TSO suspension

Intervention Type: DRUG

Placebo

Placebo solution

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jürgen Schölmerich, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Johann Wolfgang Goethe-Universität

Locations

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt a.M., Hesse, Germany

Countries

Germany

Other Identifiers

2006-000720-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TSU-2/CDA

Identifier Type: -

Identifier Source: org_study_id