Status:
RECRUITING
Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease
Lead Sponsor:
Forte Biosciences, Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 con...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 70 years at Screening.
- Has documented diagnosis of CeD confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening (intestinal biopsy and serology do not have to be performed concurrently).
- Body mass index (BMI) between 16.0 and 40.0 kg/m2, inclusive.
- Self-reported to be on a GFD for at least 12 months prior to Screening and must be willing to remain on a GFD for the duration of study participation, with the exception of the oral gluten challenge administered as a study procedure. Prior acute and resolved accidental exposures are not exclusionary.
Exclusion
- Uncontrolled CeD and/or active signs/symptoms of CeD, in the opinion of the Investigator.
- History of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression.
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06982963
Start Date
August 4 2025
End Date
February 28 2027
Last Update
November 18 2025
Active Locations (1)
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1
The Royal Melbourne Hospital
Melbourne, Australia