Spots Global Cancer Trial Database for A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
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Trial Identification
Brief Title: A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
Official Title: A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis
Study ID: NCT03649971
Conditions
Study Description
Brief 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.
Detailed Description: Familial adenomatous polyposis (FAP) is the most common polyposis syndrome. It is autosomal dominant inherited disorder characterized by early onset of hundreds to thousands of adenomatous polyps throughout colon. If left untreated, this syndrome may develop colorectal cancer (CRC). Polyps from individuals with FAP display inflammatory features associated with activation of interleukin (IL) 23/IL 17/JAK/STAT3 pathway. This inflammation is thought to contribute to further mutagenesis, culminating in tumor development. Specifically, IL-23 is linked to tumor growth and progression in CRC. Guselkumab is a human immunoglobulin monoclonal antibody directed against p19 subunit of IL-23, specifically targets IL-23 and inhibits its interaction with IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent cell activation and cytokine production, which result in less inflammation and reduce tumor development. The clinical hypothesis of this study is that treatment with guselkumab will reduce rectal/pouch polyp burden compared with baseline in active arms compared with placebo. The study is designed to determine if guselkumab has clinical activity in colorectum and duodenum, by reducing number of polyps over a period of 24 weeks. Participants will be randomized to 1 of 3 treatment arms (Guselkumab 100 mg \[milligram\] SC \[subcutaneous\], Guselkumab 300 mg SC, and placebo SC). Efficacy evaluations include rectal/pouch polyp burden assessment, biomarker analysis include discrete IL-23 signaling effector proteins (IL-23R, pSTAT3, Il-17A) and safety evaluations will include monitoring of adverse events, laboratory tests, vital sign measurements, and physical examination. Safety will be monitored throughout study (up to Week 60).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
Universitätsklinikum Ulm, Ulm, , Germany
Sourasky MC, Tel Aviv, , Israel
Academisch Medisch Centrum Universiteit van Amsterdam, Amsterdam, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po, Poznan, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warszawa, , Poland
Pan American Center for Oncology Trials LLC, Río Piedras, , Puerto Rico
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Clinic I Provincial de Barcelona, Madrid, , Spain
Karolinska Universitetssjukhuset, Stockholm, , Sweden
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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