Living with celiac disease?
You may qualify for this phase 2 clinical trial.
This study is evaluating a potential new treatment for celiac disease. Eligible participants will receive compensation for time and study-related travel.
Requirements
18 – 70 years old
Diagnosed with biopsy-confirmed celiac disease for 12+ months
On a gluten-free diet for 12+ months
About
In this study, Forte Biosciences is exploring whether FB102 can safely and effectively help adults with celiac disease. FB102 is an investigational antibody designed to block the immune responses that cause intestinal damage and symptoms when people with celiac disease ingest gluten.
Participation Includes:
Screening (up to 45 days; 1 visit)
Eligibility assessment, medical record review, physical exam, lab tests, ECG (heart test), and upper endoscopy with biopsy.
Treatment (11 weeks)
- Receive 8 infusions of either FB102 or placebo
- During an 8-week gluten challenge, consume 8 grams of gluten daily for 2 weeks, then 3 grams of gluten daily for 6 weeks, and record symptoms in a daily diary.
- Undergo a second endoscopy with biopsy.
Safety Follow-Up (15 weeks)
Health monitoring through physical exams, lab tests, and ECGs (heart tests).
FAQs
FB102 is an antibody designed to block interleukin-2 (IL-2) and interleukin-15 (IL-15). In celiac disease patients, gluten consumption results in the production of IL-2 and IL-15 which triggers intestinal inflammation, leading to destruction of intestinal cells. The goal of FB102 is to reduce intestinal damage and symptoms attributed to celiac disease after gluten consumption.
FB102 is administered as an intravenous induction (IV placed into vein), which takes 1 hour to administer. You will remain at the clinic for 1 hour following each dose for observation. You will receive a total of 8 doses of the study drug or placebo.
Yes. FB102 has been tested in healthy people and in a small number of patients with celiac disease in previous studies, and the drug was shown to be safe and well-tolerated.
A placebo is an inactive substance with no therapeutic effect that is used to help determine whether results are due to the study drug.
A clinical trial is a study that helps researchers determine if a new treatment is safe and effective. All medications must go through multiple phases of clinical trials before they can be approved for the public.
You will be assigned to the study site nearest to you. For more information about the study site locations, please complete the screening survey to see if you may qualify.
Participating in a clinical trial is a way to help develop alternative treatment options for celiac disease. You will be part of advancing celiac disease research, while receiving study-related medical care at no cost to you.
If you pre-qualify through the online screening survey and live near a study clinic, you will be invited to schedule a phone call with a study representative to discuss your eligibility and potential participation. If you are interested, you will be contacted by the study clinic to schedule a screening visit. At this visit, you will speak to the study doctor and receive all the information you need to decide if you want to participate.
Yes. Your participation is completely voluntary. You can change your mind and withdraw from the study at any time.
In this study, participants will be randomly assigned (by chance, like flipping a coin) to receive the study drug or placebo. You will have an 80% chance of receiving the study drug and a 20% chance of receiving placebo. To make sure the results are not influenced by anyone, neither you nor the study team will know which group you are in, unless there is an urgent medical need.
You will be in the study for about 8 months.
No. All study tests, procedures, and medication will be provided to you at no cost.
Compensation for your time and travel will be available. The study team at your location will provide additional details about this before you agree to participate.
Contact the Forte Biosciences Celiac Disease Study Team at [email protected].
Questions?
Contact the Forte Biosciences Celiac Disease Study Team at [email protected].