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

ConditionCrohn Disease

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorJanssen Research & Development, LLC

About this trial

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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

JNJ-78934804
Guselkumab

Treatment groups

460 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov