Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.
- Conditions
- Induction of remission in active Crohn´s diseaseMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2006-000720-13-AT
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn’s disease.;Secondary Objective: To study safety and tolerability (adverse events, laboratory parameters) and immunological effects of TSO suspension,<br>To evaluate the mucosal healing rate after 12-week treatment with TSO suspension,<br>To assess patients’ quality of life.<br>;Primary end point(s): Rate of patients with clinical remission at week 12 (LOCF) defined as a CDAI< 150;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Rate of patients with a reduction of > 100 points in CDAI;Timepoint(s) of evaluation of this end point: at weeks 2, 4, 6, 8, 10, and 12