A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis
3 other identifiers
interventional
77
9 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2018
Typical duration for phase_1
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedStudy Start
First participant enrolled
November 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2022
CompletedFebruary 3, 2025
January 1, 2025
2.8 years
August 27, 2018
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24
Percentage change from baseline in rectal/pouch polyp burden (sum of the polyp diameters) at Week 24 will be determined through endoscopy.
Baseline, Week 24
Secondary Outcomes (14)
Percentage Change from Baseline in Number of Colorectal Polyps
Baseline, Weeks 24 and 52
Percentage Change from Baseline in Number of J-pouch Polyps
Baseline, Weeks 24 and 52
Percentage Change from Baseline in J-pouch Polyp Burden
Baseline, Weeks 24 and 52
Percentage Change from Baseline in Number of Duodenal Polyps
Baseline, Weeks 24 and 52
Percentage Change from Baseline in Duodenal Polyp Burden
Baseline, Weeks 24 and 52
- +9 more secondary outcomes
Study Arms (3)
Guselkumab Dose 1
EXPERIMENTALParticipants will receive guselkumab Dose 1 subcutaneous (SC), 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48.
Guselkumab Dose 2
EXPERIMENTALParticipants will receive guselkumab Dose 2 SC, 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48.
Placebo
PLACEBO COMPARATORParticipants will receive placebo SC, 6 doses every 4 weeks from Week 0 to Week 20.
Interventions
Guselkumab SC will be administered every 4 weeks.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Mayo Clinic
Phoenix, Arizona, 85054, United States
City of Hope
Duarte, California, 91010, United States
Yale University
New Haven, Connecticut, 06519, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
University of South Florida
Tampa, Florida, 33606, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Wexner Medical Center at the Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84132, United States
University of Washington
Seattle, Washington, 98195, United States
Hopital Edouard Herriot - CHU Lyon
Lyon, 69437, France
APHM Hopital Timone
Marseille, 13385, France
Universitatsklinikum Bonn
Bonn, 53127, Germany
Universitatsklinikum Ulm
Ulm, 89070, Germany
Sourasky MC
Tel Aviv, 64239, Israel
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, 1105 AZ, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Po
Poznan, 60 355, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Pan American Center for Oncology Trials LLC
Rio Piedras, 00935, Puerto Rico
Hosp Univ Vall D Hebron
Barcelona, 8035, Spain
Hosp Clinic de Barcelona
Barcelona, 8036, Spain
Karolinska Universitetssjukhuset
Stockholm, 171 76, Sweden
Related Publications (1)
Stone JK, Mehta NA, Singh H, El-Matary W, Bernstein CN. Endoscopic and chemopreventive management of familial adenomatous polyposis syndrome. Fam Cancer. 2023 Oct;22(4):413-422. doi: 10.1007/s10689-023-00334-3. Epub 2023 Apr 29.
PMID: 37119510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 28, 2018
Study Start
November 19, 2018
Primary Completion
September 13, 2021
Study Completion
March 23, 2022
Last Updated
February 3, 2025
Record last verified: 2025-01