A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

Official Title

A Phase 1b, Multicentre, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis

Summary:

The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden.

Trial Description

Primary Outcome:

  • Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24
Secondary Outcome:
  • Percentage Change from Baseline in Number of Colorectal Polyps
  • Percentage Change from Baseline in Number of J-pouch Polyps
  • Percentage Change from Baseline in J-pouch Polyp Burden
  • Percentage Change from Baseline in Number of Duodenal Polyps
  • Percentage Change from Baseline in Duodenal Polyp Burden
  • Change in International Society for Gastrointestinal Hereditary Tumours (InSiGHT) Stage
  • Change in Spigelman Stage Score
  • Trough Concentration of Guselkumab
  • Number of Participants with Anti-guselkumab Antibodies
  • Anti-guselkumab Antibodies Serum Titers
  • Number of Participants with Adverse Events as a Measure of Safety
  • Number of Participants with Vital Sign Abnormalities as a Measure of Safety and Tolerability
  • Number of Participants with Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability
  • Relative Changes to Baseline in Levels of Interleukin (IL)-23 Effector Proteins in Biopsy Tissue

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society