RecruitingRecruiting
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
NCT07577843 · Janssen Research & Development, LLC
In plain English
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Official title
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
About this 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).
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
Study design
Enrollment target: 460 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-05-22
Estimated completion: 2030-07-12
Last updated: 2026-07-06
Interventions
Drug: JNJ-78934804Drug: Guselkumab
Primary outcomes
- • Co-Primary: Percentage of Participants with Clinical Remission at Week 48 (At Week 48)
- • Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48 (At Week 48)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (22)
Clinnova ResearchRecruiting
Anaheim, California, United States
Gastro SB ClinicRecruiting
Chula Vista, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Sanchez Clinical Research, IncRecruiting
Miami, Florida, United States
GCP Clinical ResearchRecruiting
Tampa, Florida, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
IBD SARecruiting
Kurralta Park, Australia
GI Research Institute (G.I.R.I.)Recruiting
Vancouver, British Columbia, Canada
London Digestive Disease InstituteRecruiting
London, Ontario, Canada
Bnai Zion Medical CenterRecruiting
Haifa, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
National Hospital Organization Hirosaki National HospitalRecruiting
Hirosaki, Japan
Kagoshima IBD Gastroenterology ClinicRecruiting
Kagoshima, Japan
Japanese Red Cross Kumamoto HospitalRecruiting
Kumamoto, Japan
Japanese Red Cross Osaka HospitalRecruiting
Osaka, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalRecruiting
Sapporo, Japan
Bezmialem University Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Kocaeli University Medical FacultyRecruiting
Kocaeli, Turkey (Türkiye)
Mersin University Medical FacultyRecruiting
Mersin, Turkey (Türkiye)