RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FB102 IN ADULT WITH CELIAC DISEASE

Launched by FORTE BIOSCIENCES, INC. · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called FB102 for adults with celiac disease, a condition where eating gluten (a protein found in wheat, barley, and rye) causes serious health issues. The study aims to find out if FB102 is safe and effective for people who have been following a strict gluten-free diet (GFD) and will be asked to eat gluten for a short time as part of the study. The trial is not currently recruiting participants, but it will include men and women aged 18 to 70 years who have been diagnosed with celiac disease and have been on a gluten-free diet for at least a year.

To join the study, participants must have a confirmed diagnosis of celiac disease and meet specific health criteria, including a certain body weight range. However, individuals with uncontrolled celiac disease or serious neurological problems related to gluten exposure cannot participate. Those who join the trial can expect to receive either the treatment or a placebo (a harmless sugar pill) without knowing which one they have received. This helps researchers determine if FB102 really works. Overall, this study is an important step in finding better options for managing celiac disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and women aged 18 to 70 years at Screening.
• • 2. Has documented diagnosis of CeD confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening (intestinal biopsy and serology do not have to be performed concurrently).
• • 3. Body mass index (BMI) between 16.0 and 40.0 kg/m2, inclusive.
• • 4. Self-reported to be on a GFD for at least 12 months prior to Screening and must be willing to remain on a GFD for the duration of study participation, with the exception of the oral gluten challenge administered as a study procedure. Prior acute and resolved accidental exposures are not exclusionary.
• Exclusion Criteria:
• • 1. Uncontrolled CeD and/or active signs/symptoms of CeD, in the opinion of the Investigator.
• • 2. History of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression.