JNJ-78934804 for Colitis, Ulcerative

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Colitis, Ulcerative+2 More
JNJ-78934804 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of a new drug, JNJ-78934804, to existing treatments for ulcerative colitis.

Eligible Conditions
  • Colitis, Ulcerative

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Week 48

Up to Week 48
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Antibodies to Golimumab
Percentage of Participants with Antibodies to Guselkumab
Percentage of Participants with Neutralizing Antibodies to Golimumab
Percentage of Participants with Neutralizing Antibodies to Guselkumab
Percentage of Participants with Serious Adverse Events (SAEs)
Serum Concentrations of Golimumab Over Time
Serum Concentrations of Guselkumab Over Time
Titers of Antibodies to Golimumab
Titers of Antibodies to Guselkumab
Week 24
Percentage of Participants with Clinical Remission at Week 24
Week 48
Percentage of Participants with Clinical Remission at Week 48
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Percentage of Participants with Endoscopic Improvement at Week 48
Percentage of Participants with Symptomatic Remission at Week 48

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

11 Treatment Groups

Group 5: JNJ-78934804 (Low-dose)
1 of 11
Group 1: Guselkumab
1 of 11
Group 3: JNJ-78934804 (High-dose)
1 of 11
Group 4: JNJ-78934804 (High-dose)
1 of 11
Group 6: JNJ-78934804 (Low-dose)
1 of 11
Group 4: JNJ-78934804 (Mid-dose)
1 of 11
Group 2: Golimumab
1 of 11
Group 2: Guselkumab
1 of 11
Group 5: JNJ-78934804 (Mid-dose)
1 of 11
Group 3: Golimumab
1 of 11
Group 1: Placebo
1 of 11

Experimental Treatment

Non-Treatment Group

550 Total Participants · 11 Treatment Groups

Primary Treatment: JNJ-78934804 · Has Placebo Group · Phase 2

Group 5: JNJ-78934804 (Low-dose)
Biological
Experimental Group · 1 Intervention: JNJ-78934804 · Intervention Types: Biological
Group 1: Guselkumab
Biological
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: Biological
Group 3: JNJ-78934804 (High-dose)
Biological
Experimental Group · 1 Intervention: JNJ-78934804 · Intervention Types: Biological
Group 4: JNJ-78934804 (High-dose)
Biological
Experimental Group · 1 Intervention: JNJ-78934804 · Intervention Types: Biological
Group 6: JNJ-78934804 (Low-dose)
Biological
Experimental Group · 1 Intervention: JNJ-78934804 · Intervention Types: Biological
Group 4: JNJ-78934804 (Mid-dose)
Biological
Experimental Group · 1 Intervention: JNJ-78934804 · Intervention Types: Biological
Group 2: Golimumab
Biological
Experimental Group · 1 Intervention: Golimumab · Intervention Types: Biological
Group 2: Guselkumab
Biological
Experimental Group · 1 Intervention: Guselkumab · Intervention Types: Biological
Group 5: JNJ-78934804 (Mid-dose)
Biological
Experimental Group · 1 Intervention: JNJ-78934804 · Intervention Types: Biological
Group 3: Golimumab
Biological
Experimental Group · 1 Intervention: Golimumab · Intervention Types: Biological
Group 1: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5280
Golimumab
2014
Completed Phase 4
~3750

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 48

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,326,335 Total Patients Enrolled
16 Trials studying Colitis, Ulcerative
6,545 Patients Enrolled for Colitis, Ulcerative
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,899,313 Total Patients Enrolled
15 Trials studying Colitis, Ulcerative
6,145 Patients Enrolled for Colitis, Ulcerative

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female and of childbearing potential.
You have a confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline.
You have moderate to severe active UC.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.