Actively Recruiting
Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease
Led by Forte Biosciences, Inc. · Updated on 2025-11-18
100
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 70 years at Screening
- Documented diagnosis of celiac disease confirmed by intestinal biopsy and positive serology at least 12 months before Screening
- Body mass index (BMI) between 16.0 and 40.0 kg/m2, inclusive
- Following a gluten-free diet for at least 12 months prior to Screening and willing to continue it during the study except for the oral gluten challenge
- Prior accidental gluten exposures that have resolved are allowed
You will not qualify if you...
- Uncontrolled celiac disease or active symptoms as judged by the Investigator
- History or current neuropsychiatric problems related to gluten exposure, including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, or depression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Royal Melbourne Hospital
Melbourne, Australia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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