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

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

This will test whether taking FB102 can prevent symptoms and immune reactions in adults with well-controlled celiac disease after a planned small gluten challenge.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Forte Biosciences, Inc. (Industry-sponsored)
• Locations: 1 site (Melbourne)
• Trial ID: NCT06982963 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults age 18–70 with biopsy-confirmed celiac disease who have followed a strict gluten-free diet for at least 12 months, have BMI 16–40 kg/m2, and are willing to undergo a brief controlled gluten challenge are ideal candidates.

Not a fit: People with uncontrolled or active celiac disease or those with neuropsychiatric problems related to gluten exposure are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, FB102 could reduce symptoms and immune damage after accidental or small gluten exposures for people with celiac disease.

How similar studies have performed: Some early-phase programs targeting gluten degradation or immune modulation in celiac disease have shown promise, but there are no widely approved drugs yet to prevent gluten-triggered damage.

Eligibility criteria

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 this trial is running

Melbourne

• The Royal Melbourne Hospital — Melbourne, Australia (Recruiting)

Conditions Celiac Disease