A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
78934804UCO3001: A Phase 3 Randomized, Double-blind, and Active Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well JNJ-78934804 works and how safe it is compared with guselkumab after 48 weeks. It is for people with moderate to severe ulcerative colitis (UC), a long-term disease that causes swelling and sores in the large intestine.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You were diagnosed with UC at least 12 weeks before screening. The diagnosis must be supported by a scope exam of the bowel and a report on a tissue sample.
- Your UC is moderate to severe at the start of the study, with a modified Mayo score of 5 to 9. This score measures how active UC is.
- Your screening scope exam has an inflammation score of at least 2, confirmed by the study review team.
- Past approved medicines that act throughout the body did not work well enough, stopped working, or caused side effects you could not tolerate.
Who can't join
- Your UC affects only the rectum, the last part of the large intestine, or less than 20 centimeters from the anal opening.
- You have another type of bowel inflammation: an unclear type, one seen only under a microscope, one caused by low blood flow, or Crohn’s disease. Signs of Crohn’s disease also exclude you.
- You have or have had a long-lasting infection or infections that keep coming back.
- Guselkumab or golimumab did not work well enough, stopped working, or caused an allergic reaction or side effects you could not tolerate.
- You are pregnant or breastfeeding, or plan to become pregnant or father a child during the study or within 6 months after the last dose.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (24)
CA
- Clinnova Research · Anaheim, CA 92805More trials in Anaheim
- Gastro SB Clinic · Chula Vista, CA 91910More trials in Chula Vista
- United Medical Doctors · Los Alamitos, CA 90720More trials in Los Alamitos
- Medical Associates Research Group, Inc. · San Diego, CA 92123More trials in San Diego
CO
- Peak Gastroenterology Associates · Colorado Springs, CO 80907More trials in Colorado Springs
FL
- Florida Research Center Inc. · Lakewood Rch, FL 34211More trials in Lakewood Rch
- Sanchez Clinical Research, Inc · Miami, FL 33157-6575More trials in Miami
- GCP Clinical Research · Tampa, FL 33609More trials in Tampa
GA
- Atlanta Gastroenterology Specialists · Suwanee, GA 30024More trials in Suwanee
KY
- Tri-State Gastroenterology Assoc · Crestview Hills, KY 41017More trials in Crestview Hills
LA
- Gastroenterology Clinic of Acadiana · Lafayette, LA 70503More trials in Lafayette
- GIA Metairie · Metairie, LA 70006More trials in Metairie
MI
- Michigan Center of Medical Research · Farmington Hills, MI 48334More trials in Farmington Hills
MO
- GIA Kansas City · Lee's Summit, MO 64086More trials in Lee's Summit
NC
- University of North Carolina Hospital · Chapel Hill, NC 27599-7080More trials in Chapel Hill
NY
- New York Gastroenterology Associates · New York, NY 10075More trials in New York
OH
- Great Lakes Gastroenterology Research, LLC · Mentor, OH 44060More trials in Mentor
OK
- Digestive Disease Specialists Inc · Oklahoma City, OK 73114More trials in Oklahoma City
OR
- The Oregon Clinic · Portland, OR 97220More trials in Portland
PA
- Frontier Clinical Research · Uniontown, PA 15401More trials in Uniontown
TN
- Gastro One · Cordova, TN 38018More trials in Cordova
TX
- Southern Star Research Institute, LLC · San Antonio, TX 78229More trials in San Antonio
- Tyler Research Institute, LLC · Tyler, TX 75701More trials in Tyler
WA
- GI Alliance Tacoma · Tacoma, WA 98405More trials in Tacoma