Compares JNJ-78934804 with guselkumab in people with Crohn's disease
Tests JNJ-78934804 against guselkumab in adults with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Bunkyō City, Hamamatsu, Hirosaki, Kagoshima, Kashiwa, Kobe, Kumamoto, Minatoku, Mitaka, Nagoya, Nishinomiya, Osaka, Sapporo, Sendai, Shimizu, Takamatsu, Tokyo, Yamanashi, and Yokohama, JapanSee the 24 sites
- Phase
- Phase 3
Where in Japan
- Institute of Science Tokyo HospitalBunkyō City, JapanTaking people
- Hamamatsu University HospitalHamamatsu, JapanTaking people
- National Hospital Organization Hirosaki National HospitalHirosaki, JapanTaking people
- Kagoshima IBD Gastroenterology ClinicKagoshima, JapanTaking people
- Tsujinaka Hospital KashiwanohaKashiwa, JapanTaking people
- Kobe University HospitalKobe, JapanTaking people
- Japanese Red Cross Kumamoto HospitalKumamoto, JapanTaking people
- Kumamoto University HospitalKumamoto, JapanTaking people
- Takano HospitalKumamoto, JapanTaking people
- Kitasato University Kitasato Institute HospitalMinatoku, JapanTaking people
- Kyorin University HospitalMitaka, JapanTaking people
- Nagoya City University HospitalNagoya, JapanTaking people
- Hyogo Medical University HospitalNishinomiya, JapanTaking people
- Japanese Red Cross Osaka HospitalOsaka, JapanTaking people
- National Hospital Organization Osaka National HospitalOsaka, JapanTaking people
- Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalSapporo, JapanTaking people
- Sapporo Higashi Tokushukai HospitalSapporo, JapanTaking people
- Sapporo Medical University HospitalSapporo, JapanTaking people
- Tohoku University HospitalSendai, JapanTaking people
- National Hospital Organization Shizuoka Medical CenterShimizu, JapanTaking people
- Takamatsu Red Cross HospitalTakamatsu, JapanTaking people
- The Jikei University HospitalTokyo, JapanTaking people
- Yamanashi Prefectural Central HospitalYamanashi, JapanTaking people
- Yokohama City University Medical CenterYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07577843EU 2026-525922-39-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
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: Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study; 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; Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC; Presence of draining (that is, functioning) stoma or ostomy; Currently has or is suspected of having an abscess.