Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease
ConditionCeliac Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorForte Biosciences, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FB102
Biological/VaccineFB102 (10 mg/kg induction doses and 3 mg/kg or 5 mg/kg maintenance doses) or placebo arms in a 2:2:1 ratio.
Placebo
Other interventionPlacebo
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: AExperimental treatment 1 intervention
Group B: BExperimental treatment 1 intervention
Group C: CPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the VCIEL
Vh:Cd and IEL Composite Scale (VCIEL)
Time frame
78 DaysSponsors and contacts
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Source ClinicalTrials.gov