Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06982963, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Forte Biosciences, Inc.
- Trial code
- NCT06982963
- Record updated
- 18 November 2025
- Original description
This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of FB102 in Adult Participants With Celiac Disease on a Gluten Free Diet
This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.
Inclusion: Men and women aged 18 to 70 years at Screening; 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); Body mass index (BMI) between 16.0 and 40.0 kg/m2, inclusive; 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: History of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression; Uncontrolled CeD and/or active signs/symptoms of CeD, in the opinion of the Investigator.