A Study of Guselkumab in Participants With Familial Adenomatous Polyposis



Status:Recruiting
Conditions:Colorectal Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:November 19, 2018
End Date:February 11, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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

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.


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 81 milligram (mg) of aspirin a day or 650 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

- Duodenum or colon/rectum/pouch with high grade dysplasia or cancer on biopsy at
screening

- Duodenal or colorectal polyp >1 centimeter (cm) not excised at the screening
evaluation
We found this trial at
11
sites
Jacksonville, Florida 32216
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Chicago, Illinois 60637
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Columbus, OH
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Philadelphia, Pennsylvania 19111
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Phoenix, AZ
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