EUCTR2006-000720-13-DK
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Induction of remission in active Crohn´s disease
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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,
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,
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect efficacy, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])Arterial inflammation in subjects with elevated lipoprotein a (Lp[a])MedDRA version: 20.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000022953Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-002106-13-SEAthera Biotechnologies AB40
Active, not recruiting
Not Applicable
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCPatients with Primary Biliary Cirrhosis at risk of disease progressionMedDRA version: 9.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosisEUCTR2007-004040-70-ATDr. Falk Pharma GmbH183
Active, not recruiting
Phase 1
Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisPBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liverMedDRA version: 17.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2007-004040-70-SEDr. Falk Pharma GmbH144
Active, not recruiting
Not Applicable
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.EUCTR2006-000720-13-CZDr. Falk Pharma GmbH400
Active, not recruiting
Not Applicable
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)EUCTR2007-001315-31-SEDr. Falk Pharma GmbH110