FB102 versus placebo for adults with celiac disease after a gluten challenge

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial testing FB102 in adults with biopsy-confirmed celiac disease who have been on a strict gluten-free diet. Participants will be randomly assigned to receive FB102 or placebo and then undergo a controlled oral gluten challenge while remaining on their gluten-free diet otherwise. The study will measure clinical symptoms, safety, pharmacokinetics, and pharmacodynamic markers of immune response following the gluten exposure. Results will help determine whether FB102 reduces gluten-triggered intestinal and symptom responses compared with placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women aged 18 to 70 years at Screening.
2. 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).
3. Body mass index (BMI) between 16.0 and 40.0 kg/m2, inclusive.
4. 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 Criteria:

1. Uncontrolled CeD and/or active signs/symptoms of CeD, in the opinion of the Investigator.
2. History of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression.

Where it's running

• The Royal Melbourne Hospital
  Melbourne, Australia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.