Test of JNJ-78934804 vs guselkumab in moderately to severely active ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares the efficacy and safety of JNJ-78934804 to guselkumab in adults with moderately to severely active ulcerative colitis. Eligible participants have documentation of UC with a Mayo score indicating active disease and endpoint endoscopy confirming inflammation, after inadequate response to prior therapies. Participants are randomized to receive either JNJ-78934804 or guselkumab and are followed for 48 weeks to assess outcomes. The study is conducted at sites in Arizona and California and is sponsored by Janssen Research & Development, LLC. Primary goals include efficacy at Week 48 and safety profiles for the two treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• GIA Sun City
  Sun City, Arizona, United States Recruiting
• Clinnova Research
  Anaheim, California, United States Recruiting
• Gastro SB Clinic
  Chula Vista, California, United States Recruiting
• United Medical Doctors
  Los Alamitos, California, United States Recruiting
• Medical Associates Research Group, Inc.
  San Diego, California, United States Recruiting

+268 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.