Overview

A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

Status:
Active, not recruiting
Trial end date:
2022-03-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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