RESEARCH STUDIES: Index


EFCCA - results of first EFCCA Pan European IBD Patients Study [Click Here]

IFPMA - Clinical trials portal [Click Here]

Traficet - EN CCX282B oral investigational study in Crohn's disease [Click Here]

EFCCA Note: Patients should also consult their Physicians.

Traficet – EN : Clinical Development of CCX282-B for Crohn’s Disease

CCX282-B is a first-in-class oral anti-inflammatory investigational therapeutic for the treatment of inflammatory bowel disease (IBD), which is currently in clinical development for Crohn's disease. As of October 2006, more than 200 patients have received CCX282-B in various clinical trials.

About the CCX282-B Crohn’s Disease Trial (CL004_282)

A PHASE II/III clinical trial in patients with moderate to severe Crohn’s disease (CL004_282) is ongoing in many countries and centers around the world, including Europe, where the study is ongoing in Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, The Netherlands, Poland, Sweden and the UK. The trial in which CCX282-B is being evaluated is designed to find out how effective and safe the drug is in comparison to taking placebo. Both men and women, age 18 years or older and who are experiencing worsening of their Crohn’s Disease, are eligible to enroll, subject also to the following inclusion and exclusion criteria.

Key Inclusion Criteria for this trial are:

• moderate to severe Crohn's Disease
• CDAI 250-450
• CRP >7.5
• signed written informed consent

Key Exclusion Criteria for this trial are:

• >100 cm of small bowel resected
• ileostomy, colostomy or rectal pouch
• diagnosis of ulcerative colitis or indeterminate colitis
• evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
• hepatitis B, C or HIV infection
• infection in the past that required treatment with intravenous antibiotics
• serious or GI infection in the previous 12 weeks
• TNF inhibitor therapy in the previous 12 weeks; however, stable doses of other therapies, i.e., azathioprine, 6-mercaptopurine, glucocorticoids up to 20 mg prednisone-equivalent, are allowed)

The trial will enroll approximately 420 patients for a trial duration of 12 months. A list of clinical study sites can be found at: www.clinicaltrials.gov (Study Identifier: NCT00306215).

About CCX282-B

CCX282-B is an experimental drug that works by reducing the movement of certain immune cells from the blood stream into the gut wall and may help to dampen the chronic inflammatory process in Crohn’s disease, through specifically targeting a chemokine receptor CCR9, which is involved in migration of T cells to the digestive tract.
There are currently no drugs licensed for use in Crohn’s disease that have been developed to specifically block such cell movement: CCX282-B is the first drug to be evaluated in this new category. The drug, can be taken by mouth as a capsule

Clinical Trial Results To-Date

Across four Phase 1 trials, with a total of 145 subjects, CCX282-B has been well tolerated.
Earlier in 2006, ChemoCentryx completed a Phase 2 clinical trial with CCX282-B administered daily for 28 days compared to placebo. This trial was a double-blind, placebo-controlled trial to evaluate the safety, tolerability, and clinical activity of CCX282-B in subjects with active, moderate to severe Crohn's disease. The drug was well tolerated and demonstrated clinical activity compared to placebo in subjects with elevated CRP and/or CDAI scores. Results from the “Traficet-EN” trial were presented at the October 2006 United European Gastroenterology Week (UEGW) meeting in Berlin.

As shown above more information about Traficet – EN and the studies are available at: www.clinicaltrials.gov and at: www.chemocentryx.com

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EFCCA Pan European IBD Patients Questionnaire 2005
For information about this survey and the results from the > 5600 completed IBD survey forms from Crohn's and colitis patient members in 7 of the EFCCA member association countries ( Denmark, Italy, The Netherlands, Portugal, Spain, Switzerland and the United Kingdom) go to the What's New page and scroll down. There you will also find related downloadable documents.

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IFPMA - the International Federation of Pharmaceutical Manufacturers Associations has launched a second stage of their Clinical Trials Portal.
The Portal, which contains information on ongoing and completed clinical trials from the research-based pharmaceutical industry, is also available in German, French, Japanese and Spanish as well as English. For more info go to: www.ifpma.org/clinicaltrials

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