JNJ-78934804 in Crohn’s disease: a comparison to guselkumab for moderate to severe cases

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 is a phase 3 interventional study assessing the efficacy and safety of JNJ-78934804 versus guselkumab in participants with moderately to severely active Crohn’s disease. Eligible adults have a confirmed Crohn’s diagnosis and a CDAI score between 220 and 450, with active ileal and/or colonic disease. Participants must have had an inadequate response or intolerance to prior systemic therapies. The study compares two biologic approaches, using centralized endoscopic assessments to confirm disease activity, with treatment over a 48-week period. Locations include several sites in Arizona and California, led by Janssen Research & Development.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
* Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \>= 220 but less than or equal to (\<=) 450 and either: a. Mean daily stool frequency (SF) count \>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
* Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
* Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies

Exclusion criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
* Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
* Presence of draining (that is, functioning) stoma or ostomy
* Has a history of short bowel syndrome, is missing greater than (\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
* Currently has or is suspected of having an abscess

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

+237 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.