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

Sponsor
Forte Biosciences, Inc.
Study ID
NCT06982963
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • FB102 — BIOLOGICAL
    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.
  • Placebo — OTHER
    Placebo

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Nov 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    FB102
  • Experimental: B
    FB102
  • Placebo Comparator: C
    Placebo

Primary Outcome Measure

Change from baseline in the VCIEL [ Time Frame: 78 Days ]

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