I was doing research on another drug today – Vedolizumab. It is a drug currently used in Cystic Fibrosis and showed some promise in Phase 1 clinical trials. Great!
They opened Phase 2 clinical trials in October 2016. They closed trials in October 2018 due to a lack of patient enrollment. They had one location in Maryland for the trial and one participant.
We know from the Nexvax trial that only about 1/3 of people that contacted a location actually got into the trial for one reason or another, but the inclusion criteria were pretty easy. One had to provide the biopsy and blood work results from diagnosis, confirm a gluten free diet for >12 months, and pass a basic physical.
This is where this study gets a little harder to get into – one of the exclusion criteria was “Abnormal MARSH score on enrollment histopathology.” I have to tell you, I’m fairly certain I have an abnormal MARSH score even 7 years into a gluten free diet with negative blood work for over 4 years. I’m also fairly certain that most Celiac sufferers still have abnormal MARSH scores too. So, this criteria and many others may have been too strict for a study.
But in 18 months, they were only able to find 1, just one, participant. Even with the significant exclusion criteria – only 1 participant.
I also had never heard of this trial until I looked it up and started this research. I know the Nexvax and Latiglutenase people have done a great job of getting the word out about their studies. Maybe the Vedolizumab people can take a lesson and re-launch their study with a little more marketing push to get people interested.
I think there are ways they could improve participation but….
We as a community have to do better. If we want science to advance and provide us more, we have to do more. If you are healthy enough and live near a clinical trial location, I encourage you to participate in a clinical trial. Don’t get me wrong. It is scary not knowing what is going on in your body. We are so attuned to what is wrong in our bodies due to the constant onslaught of gluten in our environment that it is scary to think we might purposefully make ourselves sick for the sake of science. But that is just it. We can’t move forward without some risk and clinical trial risk is scary, but manageable.
Call a location and ask about criteria and if you can help. If you can’t or don’t like the drug, don’t do the study. That’s fine, but at least you tried.
Also, there are clinical trials going on that do not involve interventional medications. One wants to study immunological response to gluten challenges – that one is in Dallas and Seattle. That one will probably suck, but it is important. Here’s the link. There are 41 actively recruiting studies available for your participation according to ClinicalTrials.gov. Find one you like and do it!!!
My bottom line is – if you can participate, please do. Also, I’ll keep you in the loop on studies as I come across them.