The FB102-301 clinical research study is for people who have celiac disease who are currently on a gluten-free diet. The study will test the investigational drug called FB102 to learn if it can be a potential new treatment for celiac disease.
Study participants may be able to join the study if they meet the following requirements:
18 to 70 years of age
Diagnosed with celiac disease by a provider at least 12 months prior to screening
Have maintained a gluten-free diet for at least 12 months
Other study requirements will apply
Participation in the study lasts up to 33 weeks (approximately 7.5 months). Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The study offers participants compensation for their time and a travel program to assist with arranging and reimbursing for travel to and from a site
All participants will be offered the opportunity to continue participation for up to 2 years in the optional extension period. The extension period will consist of site visits approximately every 3 months for continued data collection and monitoring.
The investigational study drug, FB102, is a monoclonal antibody. It is designed to block signals the immune system sends when it detects gluten. Blocking these signals may prevent inflammation and damage in the small intestine caused by gluten ingestion in people with celiac disease.
Approximately 4 out of every 5 participants (80%) will receive the study drug. The other 20% of participants will receive placebo, which looks like and is administered the same as the study drug but does not have active ingredients. The placebo group is important for comparing results at the end of the study.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies.
Celiac disease (CeD) is an autoimmune disorder where the consumption of gluten causes damage to the lining of the small intestines, preventing the proper absorption of nutrients. It is estimated that celiac disease affects about 1% of the world population.
Common symptoms associated with celiac disease include:
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive. A member of the study team will go through the ICF with you. You will be given time to ask questions and consider if you’d like to participate in the study.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in a clinical research study is your choice, and you may stop (or withdraw) at any time.
If you have additional questions about participating in the FB102-301 clinical trial for celiac disease, contact a study clinic near you.