The primary objective of this study is to evaluate the effect of Traficet-EN compared to placebo on the small intestinal mucosal morphology of biopsy specimens taken from subjects with celiac disease on a long-standing gluten-free diet, before and after gluten exposure. Secondary objectives of this study include evaluation of Traficet-EN compared to placebo on small intestinal mucosal inflammation, gluten-induced celiac-type serology, symptom scores, malabsorption parameters and safety and tolerability profiles. If our Phase II clinical trial in celiac disease is successful, we plan to launch further trials to obtain an indication for Traficet-EN in treatment of patients with this disease.This drug was originally created for use in people with Crohn's Disease but is now being studied for Celiac Disease. It focuses on Chemokines and other chemoattractants which direct inflammatory responses by serving to precisely coordinate the movement of cells of the immune system. Inappropriate activity of the chemokine network is at the core of numerous autoimmune and inflammatory conditions like Celiac Disease. By selectively blocking a given chemokine and chemokine receptor combination, and largely leaving other chemokine-chemokine receptors interactions unimpeded, even aggressive forms of chronic inflammation and autoimmunity can potentially be brought under control in a safe and effective manner.
This page has good information on Chemokines.
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2 comments:
I've been given some information from an expert on clinical trials... Thanks Joey!
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Hey Zach,
I'll give you a breakdown of what the information on this page means:
http://www.clinicaltrials.gov/ct2/show/NCT00540657?term=CCX282&rank=1
That's the one you provided today in your blog from ChemoCentryx.
First of all, the official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Testing CCX282-B in the Treatment of Celiac Disease
Double-Blind means that neither the patient nor the doctor prescribing the medicine knows whether or not the patient is receiving placebo. This is done to make sure bias does not come into play in clinical research. Randomized means that it's completely random as to whether or not the patient receives the study drug or the placebo. Placebo-Controlled simply means that the control group in this experiment is the group of patients who get placebo.
There are a small number of people involved in each trial who know which patients are receiving placebo and which are receiving the study drug. That would mainly be the bio statisticians, however there will always be at least one doctor involved in the trial who knows which patients receive study drug, but it can't be a doctor involved in prescribing the medication, again to keep bias from entering into play. If need be, the investigator (doctor prescribing the meds) can be "unblinded", that is, find out whether or not his/her patient is receiving the study drug. If an adverse event occurs which can threaten their life, it would be essential for their doctor to find out if they've received placebo or study drug.
The Inclusion/Exclusion Criteria are meant merely as guidelines. If possible, everyone enrolled in the trial must meet all of those. However, there can be exceptions made. If the investigator thinks that the patient could benefit from the drug (even though they don't know whether or not the patient will actually receive the drug) an exception can be made. A small amount of paperwork, called a protocol exception, must be completed. For example, one of the inclusion criteria in this study is that the subject must have followed a gluten-free diet for at least 24 months. You have only doing it for what, 4 or 5 months? If you went to a doctor who was one of the investigators in this study and that doctor thought you could benefit from the drug, an exception could be made to allow you to enter the trial. If one of the inclusion/exclusion criteria are in place strictly for your safety, such as the subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment, an exception most likely can't be made unless the doctor has absolutely no morals!
http://www.fiercebiotech.com/special-reports/chemocentryx-top-20-vc-deals-2008
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