NCT06982963

Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Forte Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
BIOLOGICAL	FB102	FB102 (10 mg/kg induction doses and 3 mg/kg or 5 mg/kg maintenance doses) or placebo arms in a 2:2:1 ratio.
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-08-04
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2025-05-21
• Last updated: 2025-11-18

Locations

1 site across 1 country: Australia