If you’ve ever considered participating in a clinical trial, what have you pictured?
It can be hard to imagine the specific place you would have your study visits and the study team you would interact with. To provide a more complete picture of clinical trial participation, we met with Dr. Amelie Therrien, a gastroenterologist at Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA. Dr. Therrien is an adult gastroenterology specialist and serves as a study doctor for the Solutions for Celiac study.
Dr. Therrien became involved as a study doctor for the Solutions for Celiac study because she “thinks it is important for the advancement of new therapeutics in celiac disease.”
One of the unique features of BIDMC is that many of the clinical staff also have celiac disease. Because of this, Dr. Therrien says, the staff “have a deeper understanding” of what it means to have celiac disease and the burdens of the gluten-free diet.
As a study doctor, Dr. Therrien directly interacts with potential trial participants to make sure the study is right for them. She and her team at the BIDMC review participants’ medical histories and current symptoms to make sure they match study requirements. Study doctors and the clinic staff follow the health and safety of participants throughout the trial.
Dr. Therrien explained that all study visits for enrolled participants take place at the BIDMC Celiac Center, which is in the GI Clinic. Clinic staff ask participants health and study-related questions at each visit and a trained phlebotomist performs a blood draw if the visit requires it. Study participants also meet with Dr. Therrien at most of their visits.
According to Dr. Therrien, the Solutions for Celiac study is unique because all participants receive the study medication latiglutenase at some point during the study (instead of some participants receiving only the placebo). There are also no endoscopy or biopsy procedures required as part of the trial.
Participation in clinical trials is important for the development of new therapies for celiac disease. Dr. Therrien explained that when people with celiac disease are “motivated to invest time and effort” in treatments beyond the gluten-free diet by participating in a trial, they are demonstrating to the pharmaceutical industry, the FDA and others that people with celiac disease do want a treatment. This can encourage more research into celiac disease and accelerates the development of more treatments.
Dr. Therrien acknowledged that clinical trial participation is not for everyone, and that each person should do “what they are comfortable with” and what fits into their schedule. She noted that an advantage to participating in a study is that “you gain lots of information regarding your disease throughout the study visits,” which can be helpful for people who do not have regular follow-up visits with a GI doctor, especially one who specializes in celiac disease.
The Solutions for Celiac study is a Phase 2 clinical trial testing the investigational medication latiglutenase as a potential treatment for celiac disease. You can read more about the study design and about Jennifer Sealey-Voyksner, a co-founder and Chief Scientific Officer of ImmunogenX. Latiglutenase has been studied for a number of years, with recent positive results presented at the 2022 Digestive Disease Week conference. BIDMC is one of multiple locations across the US where the Solutions for Celiac study is taking place.
Beyond Celiac is helping to recruit for this study as part of our commitment to accelerating research. For more general information about clinical trial participation, you can view the replay of our May Town Hall.
To learn more about the Solutions for Celiac Study and to see if you qualify, visit SolutionsforCeliac.com.
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