Clinical trial NCT01279577: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn´s Disease
Keywords: Crohn´s disease
Trichuris suis
randomized
placebo
induction of remission
porcine whipworm
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction of > 100 points in CDAI
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Frankfurt a.M.
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität
state: Hessen
Study officials:
affiliation: Klinikum der Johann Wolfgang Goethe-Universität
name: Jürgen Schölmerich, Prof.
role: PRINCIPAL_INVESTIGATOR
References: