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

Crohn´s Disease Clinical Trial

— TRUST-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279577
• Other study ID #: TSU-2/CDA
• Secondary ID: 2006-000720-13
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2011
• Last updated: February 9, 2015
• Start date: November 2010
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn´s Disease

Intervention

Drug:
• Low dose TSO
Low dose TSO suspension
• Medium dose TSO
Medium dose TSO suspension
• High dose TSO
High dose TSO suspension
• Placebo
Placebo solution

Locations

Country	Name	City	State
Germany	Klinikum der Johann Wolfgang Goethe-Universität	Frankfurt a.M.	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150		12 weeks	No
Secondary	Reduction of > 100 points in CDAI		12 weeks	No
Secondary	Adverse events		12 weeks	Yes