RecruitingPhase 2NCT06982963

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


Sponsor

Forte Biosciences, Inc.

Enrollment

100 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called FB102 and Placebo for people with celiac disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFB102

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.

OTHERPlacebo

Placebo


Locations(1)

The Royal Melbourne Hospital

Melbourne, Australia

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NCT06982963


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