RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07577843

Registry updated: 2026-10-14

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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).

Interventions

JNJ-78934804 (Drug)
JNJ-78934804 will be administered subcutaneously.
Guselkumab (Drug)
Guselkumab will be administered subcutaneously.

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

Conditions

Crohn Disease

Locations

Clinnova Research — Anaheim, California, United States
Gastro SB Clinic — Chula Vista, California, United States
United Medical Doctors — Los Alamitos, California, United States
Medical Associates Research Group, Inc. — San Diego, California, United States
Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
Florida Research Center Inc. — Lakewood Rch, Florida, United States
Sanchez Clinical Research, Inc — Miami, Florida, United States
GCP Clinical Research — Tampa, Florida, United States
Atlanta Gastroenterology Specialists — Suwanee, Georgia, United States
Tri-State Gastroenterology Assoc — Crestview Hills, Kentucky, United States
Gastroenterology Clinic of Acadiana — Lafayette, Louisiana, United States
GIA Metairie — Metairie, Louisiana, United States
Michigan Center of Medical Research — Farmington Hills, Michigan, United States
GIA Kansas City — Lee's Summit, Missouri, United States
New York Gastroenterology Associates — New York, New York, United States
University of North Carolina Hospital — Chapel Hill, North Carolina, United States
Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
Digestive Disease Specialists Inc — Oklahoma City, Oklahoma, United States
The Oregon Clinic — Portland, Oregon, United States
Gastro One — Cordova, Tennessee, United States
Tyler Research Institute, LLC — Tyler, Texas, United States
GI Alliance Tacoma — Tacoma, Washington, United States
GEDYT — AAI, Argentina
Sanatorio Duarte Quiroz — Córdoba, Argentina
Globalpsy — La Plata, Argentina
HIGEA — Mendoza, Argentina
Cer Instituto Medico — Quilmes, Argentina
Hospital Provincial del Centenario — Rosario, Argentina
Banksia Trials SA — Adelaide, Australia
Royal Prince Alfred Hospital — Camperdown, Australia
Monash Medical Centre — Clayton, Australia
The Melbourne Gut Clinic Epworth Hospital — East Melbourne, Australia
SA Gastrointestinal Services IBD SA — Kurralta Park, Australia
Macquarie University — Macquarie University, Australia
Fiona Stanley Hospital — Murdoch, Australia
John Hunter Hospital — New Lambton Heights, Australia
Mater Misericordiae Hospital — South Brisbane, Australia
Kepler Universitatsklinikum GmbH — Linz, Austria
Krankenhaus der Barmherzigen Brüder — Vienna, Austria
Klinikum Wels Grieskirchen — Wels, Austria
O L V Ziekenhuis — Aalst, Belgium
Cliniques Universitaires Saint Luc — Brussels, Belgium
Universitair Ziekenhuis Antwerpen — Edegem, Belgium
Ghent University Hospital — Ghent, Belgium
Universitair Ziekenhuis Leuven — Leuven, Belgium
Algemeen Ziekenhuis Delta — Roeselare, Belgium
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu — Botucatu, Brazil
CDC - Centro Digestivo de Curitiba — Curitiba, Brazil
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda — Jaú, Brazil
Galileo Medical Research Ltda — Juiz de Fora, Brazil
Cliged — Macaé, Brazil
Complexo Hospitalar de Niteroi — Niterói, Brazil
Hospital De Clinicas De Porto Alegre — Porto Alegre, Brazil
Hospital Ernesto Dornelles — Porto Alegre, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto — Ribeirão Preto, Brazil
Pesquisare Saude — Santo André, Brazil
BR Trials — São Paulo, Brazil
Solare Trials — São Paulo, Brazil
Rocco And Nazato Servicos Medicos Ltda — São Paulo, Brazil
INTEGRAL Pesquisa e Ensino — Votuporanga, Brazil
South Edmonton Gastroenterology Research Clinic — Edmonton, Alberta, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI) — Edmonton, Alberta, Canada
GI Research Institute (G.I.R.I.) — Vancouver, British Columbia, Canada
Nova Scotia Health Victoria General Site — Halifax, Nova Scotia, Canada
Viable Clinical Research — Kentville, Nova Scotia, Canada
London Digestive Disease Institute — London, Ontario, Canada
West GTA Research Inc — Mississauga, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc — Toronto, Ontario, Canada
Toronto Digestive Disease Associates Inc — Vaughan, Ontario, Canada
CHUM - Centre hospitalier universitaire de Montreal — Montreal, Quebec, Canada
Clinique IMD — Montreal, Quebec, Canada
Peking University Third Hospital — Beijing, China
The second Xiangya Hospital of Central South University — Changsha, China
Changzhou No 2 Peoples Hospital — Changzhou, China
Chongqing General Hospital — Chongqing, China
The First People's Hospital of Foshan — Foshan, China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital — Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China
The First Affiliated Hospital of Anhui Medical University — Hefei, China
Huai'an 1st Hospital — Huai'an, China
Lanzhou University Second Hospital — Lanzhou, China
Ningbo medical center lihuili hospital — Ningbo, China
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
The Central Hospital of Wuhan — Wuhan, China
Wuxi People s Hospital — Wuxi, China
Zhongshan Hospital, Xiamen University — Xiamen, China
ZhuZhou Central Hospital — Zhuzhou, China
Hepato-gastroenterologie HK, s.r.o. — Hradec Králové, Czechia
Oblastni nemocnice Kladno a.s. — Kladno, Czechia
Fakultni Nemocnice Ostrava — Ostrava-Poruba, Czechia
Fakultni Thomayerova nemocnice — Prague, Czechia
ISCARE a.s. — Prague, Czechia
Hopital Jean Minjoz — Besançon, France
Hopital Beaujon — Clichy, France
Hopital de Bicetre — Le Kremlin-Bicêtre, France
CHU de Lille Hopital Claude Huriez — Lille, France
CHU de Montpellier Hopital Saint Eloi — Montpellier, France
CHU de Nantes hotel Dieu — Nantes, France
CHU de Nice Hopital de l Archet 2 — Nice, France
Hopital Haut Leveque CHU de Bordeaux — Pessac, France
CHU de Reims — Reims, France
Centre Hospitalier Universitaire de Saint Etienne Hopital Nord — Saint-Priest-en-Jarez, France
CHU Toulouse — Toulouse, France
CHRU de Nancy - Hopitaux de Brabois — Vandœuvre-lès-Nancy, France
Praxis Fur Gastroenteroligie — Berlin, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF) — Berlin, Germany
Krankenhaus Waldfriede Mitte — Berlin, Germany
Medizinisches Versorgungszentrum (MVZ) Dachau — Dachau, Germany
Universitatsklinikum Carl Gustav Carus Dresden — Dresden, Germany
Universitaetsklinik Erlangen — Erlangen, Germany
Studiengesellschaft Mitteldeutschland GmbH — Halle, Germany
Medizinische Hochschule Hannover — Hanover, Germany
Gastroenterologische Spezialpraxis - Berlin-Karlshorst — Karlshorst, Germany
Universitatsklinikum Schleswig Holstein Kiel — Kiel, Germany
Eugastro GmbH — Leipzig, Germany
Universitaetsklinikum Mannheim — Mannheim, Germany
Klinik und Poliklinik für Innere Medizin II Klinikum rechts an der Isar der TU Muenchen — München, Germany
Universitaetsmedizin Rostock — Rostock, Germany
Universitatsklinikum Ulm — Ulm, Germany
General Hospital of Athens Evaggelismos — Athens, Greece
Thoracic General Hospital Of Athens I Sotiria — Athens, Greece
Semmelweis Egyetem 1 — Budapest, Hungary
Semmelweis Egyetem — Budapest, Hungary
Semmelweis Egyetem 2 — Budapest, Hungary
Pannónia Magánorvosi Centrum Kft — Budapest, Hungary
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Hungary
Sushruta Multispecialty Hospital and Research Centre — Hubballi, India
Asian Institute Of Gastroenterology — Hyderabad, India
S. R. Kalla Memorial General Hospital — Jaipur, India
Lisie Hospital — Kochi, India
P D Hinduja National Hospital and Medical Research Center — Mumbai, India
Yashoda Super Speciality Hospitals — Secunderabad, India
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre — Surat, India
Gujarat Gastro and Vascular Hospital — Surat, India
Assuta Medical center — Ashdod, Israel
Bnai Zion Medical Center — Haifa, Israel
Rambam Medical Center — Haifa, Israel
Wolfson Medical Center — Holon, Israel
Shaare Zedek Medical Center — Jerusalem, Israel
Meir Medical Center — Kfar Saba, Israel
Galilee Medical Center — Nahariya, Israel
Rabin Medical Center — Petah Tikva, Israel
Sheba Medical Center — Ramat Gan, Israel
Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano — Milan, Italy
Ospedale San Raffaele di Milano — Milan, Italy
Ospedale Sacro Cuore Negrar-Verona — Negrar-Verona, Italy
Azienda Ospedaliera San Camillo-Forlanini — Roma, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS — Roma, Italy
Fatebenefratelli Isola Tiberina - Gemelli Isola — Roma, Italy
Istituto Clinico Humanitas — Rozzano, Italy
Institute of Science Tokyo Hospital — Bunkyō City, Japan
Hamamatsu University Hospital — Hamamatsu, Japan
National Hospital Organization Hirosaki National Hospital — Hirosaki, Japan
Kagoshima IBD Gastroenterology Clinic — Kagoshima, Japan
Tsujinaka Hospital Kashiwanoha — Kashiwa, Japan
Kobe University Hospital — Kobe, Japan
Kumamoto University Hospital — Kumamoto, Japan
Japanese Red Cross Kumamoto Hospital — Kumamoto, Japan
Takano Hospital — Kumamoto, Japan
Kitasato University Kitasato Institute Hospital — Minatoku, Japan
Kyorin University Hospital — Mitaka, Japan
Nagoya City University Hospital — Nagoya, Japan
Hyogo Medical University Hospital — Nishinomiya Shi, Japan
National Hospital Organization Osaka National Hospital — Osaka, Japan
Japanese Red Cross Osaka Hospital — Osaka, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital — Sapporo, Japan
Sapporo Medical University Hospital — Sapporo, Japan
Sapporo Higashi Tokushukai Hospital — Sapporo, Japan
National Hospital Organization Shizuoka Medical Center — Shimizu, Japan
Takamatsu Red Cross Hospital — Takamatsu, Japan
The Jikei University Hospital — Tokyo, Japan
Yamanashi Prefectural Central Hospital — Yamanashi, Japan
Hospital Ampang — Ampang, Malaysia
Sultan Idris Shah Hospital — Kajang, Malaysia
Hospital Queen Elizabeth — Kota Kinabalu, Malaysia
Hospital Sultanah Nur Zahirah — Kuala, Malaysia
University Malaya Medical Centre — Petaling Jaya, Malaysia
Vrije Universiteit Medisch Centrum — Amsterdam, Netherlands
Radboud Umcn — Nijmegen, Netherlands
St. Elisabeth Ziekenhuis — Tilburg, Netherlands
Alesund sjukehus — Ålesund, Norway
Sykehuset Innlandet HF Gjøvik — Gjøvik, Norway
Akershus Universitetssykehus — Lorenskog, Norway
Sykehuset Ostfold — Moss, Norway
Universitetssykehuset Nord-Norge HF — Tromsø, Norway
St. Olavs Hospital — Trondheim, Norway
Centrum Medyczne Medis ManerMed Sp Z O O — Bydgoszcz, Poland
Centrum Medyczne Plejady — Krakow, Poland
Centrum Medyczne Promed — Krakow, Poland
Medrise Sp. z o.o. — Lublin, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie — Lublin, Poland
Medicus Zaniewski i Bilski — Olsztyn, Poland
Twoja Przychodnia Opolskie Centrum Medyczne — Opole, Poland
Centrum Medyczne 'Medyk' Sp. z o.o. K. — Rzeszów, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne — Szczecin, Poland
Sonomed Sp. z o.o. — Szczecin, Poland
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii — Torun, Poland
H-T Centrum Medyczne — Tychy, Poland
Medical Network — Warsaw, Poland
Centrum Medyczne Oporow — Wroclaw, Poland
EMC Instytut Medyczny S A Penta Hospitals Przychodnie — Wroclaw, Poland
ETG Zamosc — Zamość, Poland
Uls Braga - Hosp. Braga — Braga, Portugal
Uls Santa Maria - Hosp. Santa Maria — Lisbon, Portugal
Uls Algarve Hosp Portimao — Portimão, Portugal
Uls Arrabida - Hosp. Sao Bernardo — Setúbal, Portugal
Ulsam - Hosp. Santa Luzia — Viana do Castelo, Portugal
Baneasa Tumor Center Hospital — Bucharest, Romania
Spitalul Clinic Colentina — Bucharest, Romania
Institutul Clinic Fundeni — Bucharest, Romania
Gastro Med S R L — Cluj-Napoca, Romania
Oncohelp Medical Center — Timișoara, Romania
FNsP F. D. Roosevelta Banska Bystrica — Banská Bystrica, Slovakia
Cliniq s.r.o. — Bratislava, Slovakia
ENDOMED s.r.o — Košice, Slovakia
KM Management spol. s r.o. — Nitra, Slovakia
GASTRO I. s.r.o. — Prešov, Slovakia
Gastro LM s.r.o. — Prešov, Slovakia
Ustredna Vojenska Nemocnica SNP Ruzomberok- Fakultna Nemocnica — Ružomberok, Slovakia
Inje University Haeundae Paik Hospital — Busan, South Korea
The Catholic University of Korea Daejeon St Mary's Hospital — Daejeon, South Korea
Samsung Medical Center — Gangnam Gu, South Korea
Severance Hospital Yonsei University Health System — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Kyung Hee University Hospital — Seoul, South Korea
Hosp. Arquitecto Marcide — Ferrol, Spain
Hosp. de Cabuenes — Gijón, Spain
Hosp. Univ. Infanta Leonor — Madrid, Spain
Hosp. Virgen Macarena — Seville, Spain
Hosp. Univ. I Politecni La Fe — Valencia, Spain
Hosp. Alvaro Cunqueiro — Vigo, Spain
Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern — Bern, Switzerland
National Cheng Kung University Hospital — Tainan, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
NTU Biomedical Park Hospital — Zhubei, Taiwan
Antalya Training And Research Hospital — Antalya, Turkey (Türkiye)
Bezmialem University Medical Faculty — Istanbul, Turkey (Türkiye)
Marmara University Pendik Training Hospital — Istanbul, Turkey (Türkiye)
Izmir Sehir Hastanesi — Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty — Kocaeli, Turkey (Türkiye)
Mersin University Medical Faculty — Mersin, Turkey (Türkiye)
Izmir Katip Celebi University Ataturk Training and Research Hospital — Turkey, Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
Cardiff and Vale UHB - University Hospital of Wales — Cardiff, United Kingdom
Ninewells Hospital — Dundee, United Kingdom
Glasgow Royal Infirmary — Glasgow, United Kingdom
Kings College Hospital — London, United Kingdom
Chelsea And Westminster Hospital — London, United Kingdom
St Georges Healthcare NHS Trust — London, United Kingdom
Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom

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