Study to evaluate the effectiveness and safety of 3 doses of embryonated eggs of the porcine whipworm compared to placebo (dummy drug) in the treatment of active Crohn's disease.

• Register: EUCTR
• Last refreshed on: 16 November 2015
• Main ID: EUCTR2006-000720-13-DE
• Date of registration: 29/01/2010
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: Study to evaluate the effectiveness and safety of 3 doses of embryonated eggs of the porcine whipworm compared to placebo (dummy drug) in the treatment of active Crohn's disease.
• Scientific 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 - TSO vs. placebo in active Crohn’s disease
• Date of first enrolment: 27/10/2010
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000720-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: different doses Number of treatment arms in the trial: 4

Countries of recruitment

Austria, Czech Republic, Denmark, Germany, Switzerland

Contacts

• Name: Project Management
• Affiliation: Dr. Falk Pharma GmbH

• Name: Project Management
• Affiliation: Dr. Falk Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent,
2. Man or woman between 18 and 75 years of age,
3. Established diagnosis of Crohn’s disease (CD) confirmed by endoscopic and histological, or endoscopic and radiological criteria, all of which since
at least 3 months prior to screening,
4. Localisation of CD either in terminal ileum (L1), in colon (L2) or
ileocolitis (L3), all without upper gastrointestinal involvement (- L4)
according to the Montreal classification (2005),
5. CDAI =220 and = 350 at baseline,
6. Serum CRP level = 2 x upper limit of normal (ULN) or stool calprotectin
> ULN at screening,
7. Haemoglobin = 10 g/dl at screening,
8. White blood cell count = 13.0 Gpt/L at screening,
9. Platelet count = lower limit of normal at screening,
10. Negative pregnancy test in females of childbearing potential,
11. Women of child-bearing potential have to apply during the entire duration
of the study a highly effective method of birth control, which is defined as
those which result in a low failure rate (i.e., less than 1% per year) when
used constantly and correctly such as implants, injectables, combined oral
contraceptive method, or some IUDs. The investigator is responsible for
determining whether the subject has this adequate birth control for study
participation.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 376
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion criteria:
1. Known Crohn’s lesions in the upper GI-tract (up to and including the
jejunum) with present symptoms,
2. Bowel surgery within the last 3 months prior to baseline,
3. Resection of more than 50 cm of the ileum,
4. Ileostomy or colostomy,
5. Septic complications,
6. Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium
difficile toxin in stool culture),
7. Abscess, perforation, active fistulas, or active perianal lesions,
8. Immediate surgery required (e.g., major stenosis, serious bleeding,
peritonitis, ileus),
9. Clinical signs of stricturing disease,
10. Parenteral or tube feeding,
11. Abnormal hepatic function (ALT or ALP > 2.5 x ULN at screening), liver
cirrhosis, or portal hypertension,
12. Abnormal renal function (Cystatin C > ULN) at screening,
13. Acute EBV infection at screening,
14. 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,
15. Any condition associated with significant immunosuppression,
16. Active malignancy or treatment with anticancer drugs during the last
5 years. Patients with a history of cancer and at least five years of
uneventful follow up and no signs of recurrence may be eligible as well as
patients with treated, non-metastatic cancers (e.g., basalioma),
17. Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-
a agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine,
methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the
last 3 months prior to baseline,
18. Treatment with antibiotics (e.g., metronidazole or ciprofloxacin),
antiparasitic medications within the last 2 weeks prior to baseline,
19. Treatment with topical or systemic glucocorticosteroid within the last 4 weeks prior to baseline, or within the last 8 weeks, if patients have been
treated for longer than 3 months,
20. Patients known to be steroid-dependent or refractory, as defined in ECCO
consensus guideline 2010,
21. Patients being unresponsive to both treatment with a biologic (e.g., anti-
TNF-a agents or anti-integrin agents) AND treatment with a thiopurine
(i.e., azathioprine, 6-MP, or 6-thioguanine),
22. Application of non-steroidal anti-inflammatory drugs (NSAIDs) within
2 weeks before baseline visit for more than 3 consecutive days, except
acetylsalicylic acid = 350 mg/d which is allowed,
23. Immunisation with live vaccines within 12 weeks prior to baseline or
during the study,
24. Travelling within the last 12 weeks prior to baseline or during study
participation to countries outside of Europe, U.S.A., or Canada,
25. Well-founded doubt about the patient’s cooperation, e.g., because of
addiction to alcohol or drugs,
26. Existing or intended pregnancy or breast-feeding,
27. Participation in another clinical trial within the last 30 days, simultaneous
participation in another clinical trial, or previous participation in the
TSU-2/CDA trial and having received study drug.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Induction of remission in active Crohn´s disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 250
Pharmaceutical Form: Oral suspension
Current Sponsor code: TSO 250
Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 17-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 2500
Pharmaceutical Form: Oral suspension
Current Sponsor code: TSO 2500
Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 167-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml
Product Code: TSO 7500
Pharmaceutical Form: Oral suspension
Current Sponsor code: TSO 7500
Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: week 12

Main Objective: To evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn’s disease.

Primary end point(s): Rate of patients with clinical remission at week 12 (LOCF) defined as a CDAI< 150

Secondary Objective: To study safety and tolerability (adverse events, laboratory parameters) and immunological effects of TSO suspension,
To evaluate the mucosal healing rate after 12-week treatment with TSO suspension,
To assess patients’ quality of life.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: at weeks 2, 4, 6, 8, 10, and 12

Secondary end point(s): Rate of patients with a reduction of > 100 points in CDAI

Secondary ID(s)

NCT01279577

TSU-2/CDA

Source(s) of Monetary Support

Dr. Falk Pharma GmbH