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

NCT06982963 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Forte Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982963 on ClinicalTrials.gov