Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis
January 31, 2025 updated by: Janssen Research & Development, LLC
Post-Trial Access for Guselkumab in Patients With Familial Adenomatous Polyposis Who Are Experiencing Clinical Benefit After Completing 48 Weeks of Treatment in CNTO1959COR1001
The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study CNTO1959COR1001.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 24, 2021
First Submitted That Met QC Criteria
June 24, 2021
First Posted (Actual)
July 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 31, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Neoplasms by Site
- Neoplasms
- Genetic Diseases, Inborn
- Intestinal Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Colonic Diseases
- Adenoma
- Otorhinolaryngologic Diseases
- Neoplastic Syndromes, Hereditary
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Adenomatous Polyps
- Intestinal Polyposis
- Colorectal Neoplasms
- Nasopharyngeal Neoplasms
- Adenomatous Polyposis Coli
Other Study ID Numbers
- CR108964
- CNTO1959APC4001 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.