ACeD Study Safety: Gluten Challenge and Covid-19

ACeD Study launched second part of clinical trial last month

by Kate Avery, MPH

Kanyos Bio, Inc (a wholly owned subsidiary of Anokion SA) launched their Phase 1 trial of KAN-101 in early 2020. The ACeD Study (Assessment of KAN-101 in Celiac Disease) has two parts, both evaluating the safety and tolerability of KAN-101, a treatment designed to modify the body’s immune response to gluten. In the first part, participants received one dose of KAN-101 and then were monitored. The second part of the trial launched last month. 

In the second part of the trial, participants are divided into three groups where each group will receive a different dose of KAN-101.  The study will begin with the lowest dose and assess two additional, higher, dose levels. Each participant in in their individual group will receive 3 doses of either KAN-101 or placebo, followed by a short gluten challenge. 

People with celiac disease may be most familiar with a gluten challenge in the context of their celiac disease diagnosis, where they may have had to eat gluten every day for at least 4-6 weeks in order to have an accurate biopsy of the small intestine. Gluten challenges as part of clinical trials do not always follow this same format. 

For the second part of the ACeD Study, participants complete a physician-supervised short gluten challenge. The gluten is given as a drink, so that each participant consumes the same amount. The goal of the gluten challenge is to assess the body’s immune response to gluten without causing intestinal damage. The gluten challenge may also cause celiac disease symptoms, so a physician supervises the challenge to ensure any symptoms experienced are appropriately treated. By taking blood samples after the gluten challenge, the study team can see if KAN-101 is modifying the immune response. Without the gluten challenge, it would be impossible for the study team to understand if KAN-101 is biologically active. 

Understandably, there can be concern about participating in a clinical trial with a gluten challenge. It is important to know that these challenges are always conducted under medical supervision. If you have very severe symptoms after consuming gluten, a trial with a gluten challenge may not be right for you. Other clinical trials without a gluten challenge may be a better fit. 

Clinical Trials and COVID-19

The COVID-19 pandemic has posed some challenges to clinical trials, which are being addressed by adopting specific measures to protect participants from any increased risk of COVID-19. In the ACeD Study, each site is following COVID-19 precautions, including mask-wearing, physical distancing, and increased sanitation. The sites have also reduced the number of trial participants present at one time. Since the pandemic has been going on since March 2020 in the United States, sites are well versed in the correct procedures to follow and have been following them since trials restarted.  

“We work hand in hand with our clinical sites to make sure we’re doing as much as can be done to minimize the risk to each participant.”

Dr. Simon Cooper, Anokion’s chief medical officer, explains, “We work hand in hand with our clinical sites to make sure we’re doing as much as can be done to minimize the risk to each participant. We have thought through each touchpoint with participants and introduced new protocols, including remote visits where it was possible. We want participants to feel as comfortable as possible.”

The study team has made changes to the protocol to reduce the amount of time participants must be physically present at the study site, including substituting remote visits and home blood draws where possible. 

COVID-19 safety is also a key consideration during participants’ travel to the site. Since participants may not be comfortable with public transportation, the ACeD Study offers a travel service to participants so they can get to the site without public transportation.

Participant safety is a key component of all clinical trials. If you’re considering participating in any study and have specific questions about safety, you will always have the opportunity to ask questions before you sign up. 

If you are interested in the ACeD Study, you can learn more about the study and find contact information here. If you have specific questions about the study, or want more information, contact the study team at [email protected].

Beyond Celiac is helping Kanyos Bio recruit for this study as a part of our commitment to accelerating research.