NCT04948398

Brief Summary

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

First QC Date

June 24, 2021

Last Update Submit

January 31, 2025

Conditions

Adenomatous Polyposis Coli

Interventions

GuselkumabDRUG

Guselkumab 100 milligrams (mg) will be administered subcutaneously once every 8 weeks.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Adenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 2, 2021

Last Updated

February 3, 2025

Record last verified: 2025-01