NCT06982963

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
10mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Aug 2025Feb 2027

First Submitted

Initial submission to the registry

May 13, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

May 13, 2025

Last Update Submit

November 17, 2025

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the VCIEL

    Vh:Cd and IEL Composite Scale (VCIEL)

    78 Days

Study Arms (3)

A

EXPERIMENTAL

FB102

Biological: FB102

B

EXPERIMENTAL

FB102

Biological: FB102

C

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

FB102BIOLOGICAL

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.

AB
PlaceboOTHER

Placebo

C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Melbourne Hospital

Melbourne, Australia

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 21, 2025

Study Start

August 4, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

AU(1)