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Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease
Sponsor: Forte Biosciences, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-08-04
Completion Date
2027-02-28
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
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.
Placebo
Placebo
Locations (1)
The Royal Melbourne Hospital
Melbourne, Australia