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NCT07577843

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~460 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:JNJ-78934804Guselkumab

At a glance

Recruiting sites
55 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Co-Primary: Percentage of Participants with Clinical Remission at Week 48
Measured over At Week 48
+1 more outcome measured

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

55 sites across 20 states
Japan13
Israel10
Turkey (Türkiye)6
California3
Australia3
Ontario3
Malaysia3
Florida2

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Co-Primary: Percentage of Participants with Clinical Remission at Week 48At Week 48

    Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

  • Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48At Week 48

    Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (\>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.