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

NCT07577856

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Colitis, Ulcerative

Interventions: JNJ-78934804, Guselkumab

Countries: United States, Australia, Brazil, Canada, China, Israel, Japan, Malaysia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (63)
  • Anaheim, California, United States
  • Chula Vista, California, United States
  • San Diego, California, United States
  • Colorado Springs, Colorado, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Crestview Hills, Kentucky, United States
  • Farmington Hills, Michigan, United States
  • New York, New York, United States
  • Mentor, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • San Antonio, Texas, United States
  • Adelaide, Australia
  • Kurralta Park, Australia
  • South Brisbane, Australia
  • Santo André, Brazil
  • São Paulo, Brazil
  • Edmonton, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Kentville, Nova Scotia, Canada
  • Barrie, Ontario, Canada
  • Hamilton, Ontario, Canada
  • London, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Guangzhou, China
  • Ashdod, Israel
  • Haifa, Israel
  • Haifa, Israel
  • Holon, Israel
  • + 33 more on CT.gov