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Wnt Pathway Inhibitor

A Study of JNJ-64251330 in Participants With Familial 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
No Placebo-Only Group

Summary

This trial tests a pill called JNJ-64251330 to reduce gut inflammation in people with Familial Adenomatous Polyposis (FAP). The drug works by blocking proteins that cause inflammation, aiming to lower the number of colon polyps. JNJ-64251330 is related to another drug that has shown effectiveness in reducing inflammation in a rat model of colitis.

Eligible Conditions
  • Familial Adenomatous Polyposis (FAP)
  • Adenomatous Polyposis

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,402,329 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,980,356 Total Patients Enrolled
~10 spots leftby Dec 2025
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