← Back to Search

Wnt Pathway Inhibitor

JNJ-64251330 for Adenomatous Polyposis

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 32 weeks

Awards & highlights

Study Summary

This trial will test if a new drug can help reduce the size of polyps in people with a genetic disorder that causes them to grow.

Eligible Conditions

Familial Adenomatous Polyposis (FAP)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage Change from Baseline in Colorectal Polyp Burden for Polyps >=2 mm at Week 24

Percentage Change from Baseline in Colorectal Polyp Burden for all Polyps at Week 24

Secondary outcome measures

Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Polyposis Stage (with and Without Colon)

Change in Spigelman Stage Score

Levels of JAK/STAT Pathway Signaling Effector Proteins including pSTAT-3 Relative to Baseline Levels in Colorectal Polyps

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: JNJ-64251330Experimental Treatment1 Intervention

Participants will receive oral dose of JNJ-64251330 twice daily for 24 Weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-64251330

2021

Completed Phase 1

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,266 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,863 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is JNJ-64251330 a risk-free therapy for individuals?

"The safety rating of JNJ-64251330 is a 1 because this clinical trial is in its first phase, so there are limited data points to assess both efficacy and security concerns."

Answered by AI

What is the objective of this investigation?

"This trial will measure the Percentage Change from Baseline in Colorectal Polyp Burden for all Polyps at Week 24 as its primary objective. Secondary outcomes include a report on the Percentage Change in Number of Rectal Polyps, the Change in Spigelman Stage Score (a classification system to assess risk of developing duodenal cancer), and Percentage Change in Number of Duodenal Polyps."

Answered by AI

What is the aggregate headcount for participants in this research project?

"In order to fully commence this medical study, 40 participants that meet the predetermined qualifications must join in. Potential candidates can be found at City of Hope situated in Duarte or Mayo Clinic located in Phoenix."

Answered by AI

At what number of locations is this experimental endeavor taking place?

"6 medical facilities are participating in this trial, including City of Hope in Duarte, Mayo Clinic in Phoenix and University of Miami located also at Miami. Additionally, there are 6 other clinical sites that are partaking."

Answered by AI

Are there still opportunities to participate in the research?

"Clinicaltrials.gov has revealed that this medical test is actively seeking participants since its inception on November 10th 2021. The trial was most recently updated on December 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis

2021. "A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05014360.