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FB102

Phase 2

Celiac Disease | Monoclonal antibody | Gastrointestinal |Forte Biosciences, Inc.|Last Updated: Nov 18, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06982963Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac DiseasePHASE2 RECRUITING 100Aug 4, 2025Feb 28, 2027Nov 18, 20251 Australia
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Study Endpoints
Primary Endpoints
Change from baseline in the VCIEL
78 Days

Vh:Cd and IEL Composite Scale (VCIEL)

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALFB102
BEXPERIMENTALFB102
CPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
FB102BIOLOGICALFB102 (10 mg/kg induction doses and 3 mg/kg or 5 mg/kg maintenance doses) or placebo arms in a 2:2:1 ratio.
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 (...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06982963primaryCompletionDate: changed
LOWMay 24, 2026NCT06982963studyFirstPostDate: changed