Another day, another bit about a drug in clinical trials. Today we are talking about Amlitelimab.
Amlitelimab is currently in Phase 2a/2b clinical trials for celiac disease. It is a monoclonal antibody. They are also evaluating this drug for other immune-mediated diseases, such as atopic dermatitis, asthma, and alopecia.
There are several mechanisms to make the body react in certain ways. JAK inhibitors, monoclonal antibodies, gluten degrading enzymes, and a variety of other ways. In the next couple of days, I’ll discuss each tool in the potential celiac medication toolbox. I will explain how they work.
Anyway, Sanofi, is testing Amelitelimab for people with ongoing symptoms of celiac disease. They define ongoing symptoms specifically. One gastrointestinal symptom must be moderate or greater in severity. It has to occur on at least three days out of any consecutive 7-day period. The investigator must consider this as brought on by gluten exposure.
In other words, gastrointestinal symptoms three times in a week with at least moderate to severe symptoms. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and others. For those of you that are silent celiac patients or have non-traditional celiac, this study doesn’t include you.
Note, they do say that the gastrointestinal symptoms must be brought on by gluten exposure. This is an interesting twist in this celiac research paradigm. They are acknowledging that even the most careful celiac patients are exposed to gluten unintentionally.
Researchers will perform endoscopy at the beginning of the study period. They will do another at the end to test for changes in the small intestine.
They also have an extended time optional portion of the study. They don’t mention this as a cross over period. Not sure what they are looking at there, but it’s worth a look.
This study has locations all around the country, but sadly, none in Georgia.
As I delve into reviewing all of these studies again, it brings up lots of questions. Anyway, I feel like we need a primer on clinical trials. We need to understand what they are, their phases, how to read them, and what to look for. I’ll work on that.