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Monoclonal Antibodies

Guselkumab 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 weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Awards & highlights

Study Summary

This study is evaluating whether a drug can reduce the number of polyps in people with familial adenomatous polyposis.

Eligible Conditions
  • Adenomatous Polyposis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48 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 Rectal/pouch Polyp Burden at Week 24
Secondary outcome measures
Antibodies
Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Stage
Change in Spigelman Stage Score
+11 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
8%
Upper respiratory tract infection
5%
Nasopharyngitis
1%
Endometrial cancer stage iv
1%
Injection site reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guselkumab
Ixekizumab
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Guselkumab Dose 2Experimental Treatment1 Intervention
Participants 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.
Group II: Guselkumab Dose 1Experimental Treatment1 Intervention
Participants 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.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo SC, 6 doses every 4 weeks from Week 0 to Week 20.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,615 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,960,201 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
2018. "A Study of Guselkumab in Participants With Familial Adenomatous Polyposis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03649971.
~12 spots leftby Apr 2025
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