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

RecruitingPhase 3

A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 460 · Started: May 22, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07577843

Locations in the U.S.

CaliforniaClinnova Research, Anaheim
Gastro SB Clinic, Chula Vista
United Medical Doctors, Los Alamitos
Medical Associates Research Group, Inc., San Diego
ColoradoPeak Gastroenterology Associates, Colorado Springs
FloridaFlorida Research Center Inc., Lakewood Rch
Sanchez Clinical Research, Inc, Miami
GCP Clinical Research, Tampa
GeorgiaAtlanta Gastroenterology Specialists, Suwanee
KentuckyTri-State Gastroenterology Assoc, Crestview Hills
LouisianaGastroenterology Clinic of Acadiana, Lafayette
MichiganMichigan Center of Medical Research, Farmington Hills
New YorkNew York Gastroenterology Associates, New York
North CarolinaUniversity of North Carolina Hospital, Chapel Hill
OhioGreat Lakes Gastroenterology Research, LLC, Mentor
OklahomaDigestive Disease Specialists Inc, Oklahoma City
OregonThe Oregon Clinic, Portland
TennesseeGastro One, Cordova
TexasTyler Research Institute, LLC, Tyler
WashingtonGI Alliance Tacoma, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.