A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

Conditions

• Adenomatous Polyposis Coli

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Guselkumab — DRUG
  Guselkumab SC will be administered every 4 weeks.
• Placebo — DRUG
  Placebo SC will be administered every 4 weeks.

Study Details

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.

Key Dates

Start date

Nov 19, 2018

Status verified

Jan 2025

Primary completion

Sep 13, 2021

Completion

Mar 23, 2022

Study Design

Enrollment

77 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Guselkumab Dose 1
  Participants will receive guselkumab Dose 1 subcutaneous (SC), 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48.
• Experimental: Guselkumab Dose 2
  Participants will receive guselkumab Dose 2 SC, 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48.
• Placebo Comparator: Placebo
  Participants will receive placebo SC, 6 doses every 4 weeks from Week 0 to Week 20.

Primary Outcome Measure

Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (18)

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