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

NCT07577843

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Crohn Disease

Interventions: JNJ-78934804, Guselkumab

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

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (55)
  • 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
  • Suwanee, Georgia, 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
  • Adelaide, Australia
  • Kurralta Park, Australia
  • South Brisbane, Australia
  • São Paulo, Brazil
  • Vancouver, British Columbia, Canada
  • Kentville, Nova Scotia, Canada
  • London, Ontario, Canada
  • Mississauga, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Ashdod, Israel
  • Haifa, Israel
  • Haifa, Israel
  • Holon, Israel
  • Jerusalem, Israel
  • Kfar Saba, Israel
  • Nahariya, Israel
  • Petah Tikva, Israel
  • + 25 more on CT.gov