Is celiac disease holding you back? If so, consider joining the FB102-301 study for people who have celiac disease who are currently on a gluten-free diet. The phase 2 FB102-301 study is researching a potential new drug for celiac disease.
Who can join the study?
Study participants may be able to join 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.
What does study participation involve?
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.
Participation in the study lasts up to 33 weeks (approximately 7.5 months). Study participants can expect the following:
| Review & Sign the Informed Consent Form | The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests and procedures. |
| Screening Period (up to 7 weeks) | Receive study health assessments including an upper endoscopy to confirm if you qualify for the study. |
| Study Treatment Period (11 Weeks) | Receive 8 infusions of the study drug or placebo administered intravenously. For the first 5 weeks of the study treatment period, you will receive a weekly infusion. For the next 6 weeks, you will receive the infusion every other week. |
| Follow-up Period (15 Weeks) | Visit the site 2 times to receive safety assessments, physical examinations and bloodwork. |
What is the study drug?
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.
Will I receive the study drug?
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.
Pre-qualify today
Join the FB102-301 study and help progress research for a potential new celiac disease treatment. Visit fortebiostudy.celiac.org to take the pre-screening questionnaire.
To learn more, visit fortebiostudy.celiac.org
Now enrolling patients in the FB102-301 study investigating a potential new celiac drug