If you could say anything to someone designing a drug trial for Celiac disease, what would you say?
With the stopping of the Nexvax trial and the upcoming Phase 3 trial of Larazotide acetate (INN-202), these are two completely different trials with completely different information being gathered.
Nexvax had lots of blood tests, daily surveys regarding symptoms, gluten challenges, and an optional arm to the trial with endoscopic biopsy at the beginning and end of the study. Lots and lots of tests along the way to determine how the body was responding to the drug and what was going on.
The phase 3 of Larazotide acetate study is only evaluating the outcome of daily surveys. According to the clinicaltrials.gov website that is what they are looking at, this might change but for right now, that is what the website says.
Granted Phase 2 studies are not as far along in the process as Phase 3 studies. With the less than stellar results from Larazotide’s phase 2 study, I would like to see a little more testing done. I want to see that you improved someone’s TTG IGA or stopped damage to the villi if I’m going to take a drug every day for the rest of my life.
Hence, my question – how would you design a study to evaluate the efficacy of a new Celiac drug?
I know what I want to see, but we are all smart people. What would you want to know about a drug before taking it? What data would help you make a decision about taking a drug?