A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

Completed · Phase 1 · Has a placebo group

Conditions studied: Adenomatous Polyposis Coli

In brief

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 facts

Study ID

NCT03649971

Run by

Janssen Research & Development, LLC

People needed

77

Starts

2018-11-19

Expected to finish

2022-03-23

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectum by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than (>)100 adenomas in large intestine and a family history of FAP, attenuated FAP is allowed. FAP phenotype post colectomy for polyposis with a family history of FAP may be allowed
• Post-colectomy or subtotal colectomy
• Polyps with a sum of diameters greater than or equal to (>=)10 millimeter (mm) in the rectum or pouch on biopsy at screening
• A woman of childbearing potential must agree not to get pregnant during the study and at least 12 weeks after the last dose of study administration
• A woman must agree not to breast feed or donate eggs (ova, oocytes) during the study and for a period of 12 weeks after the last administration of study drug

You may not qualify if…

• Prior use of any biologic therapy targeting interleukin (IL)-12/23, IL-17, or IL-23 receptor
• Use of non-steroidal anti-inflammatory drugs other than aspirin during the study. The use 100 milligram (mg) of aspirin a day or 700 mg of aspirin per week is allowed
• Treatment with other FAP-directed drug therapy (including NSAID [Nonsteroidal anti-inflammatory drug] drugs), unless completes a 4-week washout period prior to randomization
• High grade dysplasia or cancer on biopsy at screening in GI tract (including stomach, duodenum, and colon/rectum/pouch)
• Duodenal, colorectal, or pouch polyp: >2 centimeter (cm) unless excised at the screening evaluation; and 1 to 2 cm with evidence of high-grade dysplasia upon biopsy unless excised

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• City of Hope — Duarte, California, United States
• Yale University — New Haven, Connecticut, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Wexner Medical Center at the Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania - Perelman School of Medicine — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States
• Hopital Edouard Herriot - CHU Lyon — Lyon, France
• APHM Hopital Timone — Marseille, France
• Universitatsklinikum Bonn — Bonn, Germany
• Universitatsklinikum Ulm — Ulm, Germany
• Sourasky MC — Tel Aviv, Israel
• Academisch Medisch Centrum Universiteit van Amsterdam — Amsterdam, Netherlands
• Leiden University Medical Center — Leiden, Netherlands

Full record on ClinicalTrials.gov

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