RecruitingPhase 3NCT07577856

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis


Sponsor

Janssen Research & Development, LLC

Enrollment

644 participants

Start Date

May 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Guselkumab and a drug called JNJ-78934804 for people with colitis ulcerative. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-78934804

JNJ-78934804 will be administered subcutaneously.

DRUGGuselkumab

Guselkumab will be administered subcutaneously.


Locations(6)

Clinnova Research

Anaheim, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

GCP Clinical Research

Tampa, Florida, United States

New York Gastroenterology Associates

New York, New York, United States

Southern Star Research Institute, LLC

San Antonio, Texas, United States

Kagoshima IBD Gastroenterology Clinic

Kagoshima, Japan

View Full Details on ClinicalTrials.gov

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NCT07577856


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