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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn´s Disease

Intervention / Treatment
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* Drug: Low dose TSO
* Drug: Medium dose TSO
* Drug: High dose TSO
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose TSO<br>Low dose suspension of TSO | Drug: Low dose TSO<br>* Low dose TSO suspension<br>|
| Experimental: Medium dose TSO<br>Medium dose suspension of TSO | Drug: Medium dose TSO<br>* Medium dose TSO suspension<br>|
| Experimental: High dose TSO<br>High dose suspension of TSO | Drug: High dose TSO<br>* High dose TSO suspension<br>|
| Placebo Comparator: Placebo<br>Placebo solution | Drug: Placebo<br>* Placebo solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of > 100 points in CDAI |  | 12 weeks | 
| Adverse events |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn´s disease, Trichuris suis, randomized, placebo, induction of remission, porcine whipworm