RecruitingPhase 3

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

CO

FL

GA

KY

LA

MI

MO

NC

NY

OH

OK

OR

PA

TN

TX

WA