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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06982963

Enrollment

100

Registered

2025-05-21

Start date

2025-08-04

Completion date

2027-02-28

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

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 controlled (on a strict GFD) CeD following an oral gluten challenge.

Interventions

BIOLOGICALFB102

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.

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in the VCIEL	78 Days	Vh:Cd and IEL Composite Scale (VCIEL)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026