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
- Botucatu, Brasília, Curitiba, Jaú, Juiz de Fora, Macaé, Natal, Niterói, Porto Alegre, Ribeirão Preto, Salvador, Santo André, São Paulo, and Votuporanga, BrazilSee the 17 sites
- Phase
- Phase 3
Where in Brazil
- Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus BotucatuBotucatu, BrazilTaking people
- L2IP - Instituto de Pesquisas ClínicasBrasília, BrazilTaking people
- CDC - Centro Digestivo de CuritibaCuritiba, BrazilTaking people
- CECIP Jau - Centro de Estudos Clínicos do Interior Paulista LtdaJaú, BrazilTaking people
- Galileo Medical Research Ltda.Juiz de Fora, BrazilTaking people
- CligedMacaé, BrazilTaking people
- Liga Norte Riograndense Contra o CancerNatal, BrazilTaking people
- Complexo Hospitalar de NiteroiNiterói, BrazilTaking people
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
- Hospital Ernesto DornellesPorto Alegre, BrazilTaking people
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao PretoRibeirão Preto, BrazilTaking people
- Clinica Ibis Medicina LtdaSalvador, BrazilTaking people
- Pesquisare SaudeSanto André, BrazilTaking people
- BR TrialsSão Paulo, BrazilTaking people
- Rocco And Nazato Servicos Medicos LtdaSão Paulo, BrazilTaking people
- Solare TrialsSão Paulo, BrazilTaking people
- Integral Pesquisa e EnsinoVotuporanga, BrazilTaking 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.