Demise of a clinical trial

Yesterday brought some sad news: ImmusanT decided to discontinue the RESET CeD clinical trial.

This was the trial of the Nexvax2 vaccine for coeliac disease, which I have been participating in and previously wrote about. In fact I was also participating in several sub-studies involving gastroscopies along with extra blood draws to measure things like the behaviour of the immune system as the treatment progressed.

With almost 150 participants around the world, some had already completed their involvement, and some of us were still going. I have been having injections twice-weekly for several months and had about one month of treatment left to run (with followup after that).

But was it working?

I have heard from some other participants that they’d got to the stage of having no noticeable symptoms after ingesting gluten, and it isn’t surprising that some people would get positive responses (or it wouldn’t have got as far as a Phase 2 trial). But apparently statistical analysis across the population indicated that not enough people had good results. They stressed that there were no safety issues, it was just a question of efficacy.

For myself I’m not sure if it was working for me. But then I don’t yet know if I was on the placebo or active-drug arm of the trial! I did not have a huge physical reaction to the “gluten challenge” test at the start of the trial (although I don’t know what the immune response or the gut damage was). I’ve only had one of the three blinded challenges towards the end of the protocol before it was cancelled, and again I did not have a huge physical reaction. But then I still had a month of treatment to go, and all we know is that at least one of those three challenges would contain gluten.

What now?

For me at this point I get to skip another gastroscopy, two gluten challenges, more blood tests, as well as the daily task of updating a symptom diary on a PDA (which fed back via the mobile network to the researchers).
I do have one more blood draw this week to finish off one of the sub-studies, and a final “safety debrief” meeting later.

It’s very sad that they decided the trial wasn’t worth continuing with, but I sincerely hope that all the data we participants have been able to provide gives the researchers evidence to help them make changes and find a future avenue of investigation.

A vaccine for coeliac disease has been a cherished dream for thousands of families around the world, and this vaccine getting to a Phase 2 trial generated a lot of excitement.

Most of that excitement and hope has been dashed by this announcement, and there’s a lot of sadness in the community at the moment.

Personally I now just have to get on with life and coping with an intrusive chronic disease. But I suppose I’ve been doing that for over 36 years so far anyway. We’ll have to wait and see what the next development will be in terms of treatment/management for coeliac disease.