MedTrace Logo

A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

NCT03649971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

  • Adenomatous Polyposis Coli

Interventions

DRUG

Guselkumab

Guselkumab SC will be administered every 4 weeks.

DRUG

Placebo

Placebo SC will be administered every 4 weeks.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2021-09-13
Completion
2022-03-23
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Israel
  • Netherlands
  • Poland
  • Puerto Rico
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649971 on ClinicalTrials.gov