AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - anyAllJanssen Research & Development, LLC
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. * Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy * An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy * Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies Exclusion criteria: * Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD * Has a history of or ongoing chronic or recurrent infectious disease * Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab * Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention
๐Ÿ’Š

What it tests

  • JNJ-78934804
  • Guselkumab
๐Ÿ“

Where

279 sites
Clinnova Research
Anaheim, United States
Gastro SB Clinic
Chula Vista, United States
United Medical Doctors
Los Alamitos, United States
Medical Associates Research Group, Inc.
San Diego, United States
Peak Gastroenterology Associates
Colorado Springs, United States
Florida Research Center Inc.
Lakewood Rch, United States
Sanchez Clinical Research, Inc
Miami, United States
GCP Clinical Research
Tampa, United States

โ€ฆand 271 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy