Crohn's Disease Clinical Trials

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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

Status: Recruiting
Location: See all (247) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Clinnova Research
RECRUITING
Anaheim
Gastro SB Clinic
RECRUITING
Chula Vista
United Medical Doctors
RECRUITING
Los Alamitos
Medical Associates Research Group, Inc.
RECRUITING
San Diego
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
Florida Research Center Inc.
RECRUITING
Lakewood Rch
Sanchez Clinical Research, Inc
RECRUITING
Miami
GCP Clinical Research
RECRUITING
Tampa
Georgia
Atlanta Gastroenterology Specialists
RECRUITING
Suwanee
Kentucky
Tri-State Gastroenterology Assoc
RECRUITING
Crestview Hills
Louisiana
Gastroenterology Clinic of Acadiana
RECRUITING
Lafayette
GIA Metairie
RECRUITING
Metairie
Michigan
Michigan Center of Medical Research
RECRUITING
Farmington Hills
Missouri
GIA Kansas City
RECRUITING
Lee's Summit
North Carolina
University of North Carolina Hospital
RECRUITING
Chapel Hill
New York
New York Gastroenterology Associates
RECRUITING
New York
Ohio
Great Lakes Gastroenterology Research, LLC
RECRUITING
Mentor
Oklahoma
Digestive Disease Specialists Inc
RECRUITING
Oklahoma City
Oregon
The Oregon Clinic
RECRUITING
Portland
Tennessee
Gastro One
RECRUITING
Cordova
Texas
Tyler Research Institute, LLC
RECRUITING
Tyler
Washington
GI Alliance Tacoma
RECRUITING
Tacoma
Other Locations
Argentina
GEDYT
RECRUITING
Aai
Sanatorio Duarte Quiroz
RECRUITING
Córdoba
Globalpsy
RECRUITING
La Plata
HIGEA
RECRUITING
Mendoza
Cer Instituto Medico
RECRUITING
Quilmes
Hospital Provincial del Centenario
RECRUITING
Rosario
Australia
Banksia Trials SA
RECRUITING
Adelaide
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Monash Medical Centre
RECRUITING
Clayton
The Melbourne Gut Clinic Epworth Hospital
RECRUITING
East Melbourne
SA Gastrointestinal Services IBD SA
RECRUITING
Kurralta Park
Macquarie University
RECRUITING
Macquarie University
Fiona Stanley Hospital
RECRUITING
Murdoch
John Hunter Hospital
RECRUITING
New Lambton Heights
Mater Misericordiae Hospital
RECRUITING
South Brisbane
Austria
Kepler Universitatsklinikum GmbH
RECRUITING
Linz
Krankenhaus der Barmherzigen Brüder
RECRUITING
Vienna
Klinikum Wels Grieskirchen
RECRUITING
Wels
Belgium
O L V Ziekenhuis
RECRUITING
Aalst
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Ghent University Hospital
RECRUITING
Ghent
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Algemeen Ziekenhuis Delta
RECRUITING
Roeselare
Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
RECRUITING
Botucatu
CDC - Centro Digestivo de Curitiba
RECRUITING
Curitiba
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
RECRUITING
Jaú
Galileo Medical Research Ltda
RECRUITING
Juiz De Fora
Cliged
RECRUITING
Macaé
Complexo Hospitalar de Niteroi
RECRUITING
Niterói
Hospital De Clinicas De Porto Alegre
RECRUITING
Porto Alegre
Hospital Ernesto Dornelles
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
RECRUITING
Ribeirão Preto
Pesquisare Saude
RECRUITING
Santo André
BR Trials
RECRUITING
São Paulo
Rocco And Nazato Servicos Medicos Ltda
RECRUITING
São Paulo
Solare Trials
RECRUITING
São Paulo
INTEGRAL Pesquisa e Ensino
RECRUITING
Votuporanga
Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
RECRUITING
Edmonton
South Edmonton Gastroenterology Research Clinic
RECRUITING
Edmonton
Nova Scotia Health Victoria General Site
RECRUITING
Halifax
Viable Clinical Research
RECRUITING
Kentville
London Digestive Disease Institute
RECRUITING
London
West GTA Research Inc
RECRUITING
Mississauga
CHUM - Centre hospitalier universitaire de Montreal
RECRUITING
Montreal
Clinique IMD
RECRUITING
Montreal
Toronto Immune and Digestive Health Institute Inc
RECRUITING
Toronto
GI Research Institute (G.I.R.I.)
RECRUITING
Vancouver
Toronto Digestive Disease Associates Inc
RECRUITING
Vaughan
China
Peking University Third Hospital
RECRUITING
Beijing
The second Xiangya Hospital of Central South University
RECRUITING
Changsha
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
Chongqing General Hospital
RECRUITING
Chongqing
The First People's Hospital of Foshan
RECRUITING
Foshan
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huai'an 1st Hospital
RECRUITING
Huai'an
Lanzhou University Second Hospital
RECRUITING
Lanzhou
Ningbo medical center lihuili hospital
RECRUITING
Ningbo
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Central Hospital of Wuhan
RECRUITING
Wuhan
Wuxi People s Hospital
RECRUITING
Wuxi
Zhongshan Hospital, Xiamen University
RECRUITING
Xiamen
ZhuZhou Central Hospital
RECRUITING
Zhuzhou
France
Hopital Jean Minjoz
RECRUITING
Besançon
Hopital Beaujon
RECRUITING
Clichy
Hopital de Bicetre
RECRUITING
Le Kremlin-bicêtre
CHU de Lille Hopital Claude Huriez
RECRUITING
Lille
CHU de Montpellier Hopital Saint Eloi
RECRUITING
Montpellier
CHU de Nantes hotel Dieu
RECRUITING
Nantes
CHU de Nice Hopital de l Archet 2
RECRUITING
Nice
Hopital Haut Leveque CHU de Bordeaux
RECRUITING
Pessac
CHU de Reims
RECRUITING
Reims
Centre Hospitalier Universitaire de Saint Etienne Hopital Nord
RECRUITING
Saint-priest-en-jarez
CHU Toulouse
RECRUITING
Toulouse
CHRU de Nancy - Hopitaux de Brabois
RECRUITING
Vandœuvre-lès-nancy
Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
RECRUITING
Berlin
Krankenhaus Waldfriede Mitte
RECRUITING
Berlin
Praxis Fur Gastroenteroligie
RECRUITING
Berlin
Medizinisches Versorgungszentrum (MVZ) Dachau
RECRUITING
Dachau
Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitaetsklinik Erlangen
RECRUITING
Erlangen
Studiengesellschaft Mitteldeutschland GmbH
RECRUITING
Halle
Medizinische Hochschule Hannover
RECRUITING
Hanover
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
RECRUITING
Karlshorst
Universitatsklinikum Schleswig Holstein Kiel
RECRUITING
Kiel
Eugastro GmbH
RECRUITING
Leipzig
Universitaetsklinikum Mannheim
RECRUITING
Mannheim
Klinik und Poliklinik für Innere Medizin II Klinikum rechts an der Isar der TU Muenchen
RECRUITING
München
Universitaetsmedizin Rostock
RECRUITING
Rostock
Universitatsklinikum Ulm
RECRUITING
Ulm
Greece
General Hospital of Athens Evaggelismos
RECRUITING
Athens
Thoracic General Hospital Of Athens I Sotiria
RECRUITING
Athens
Hungary
Pannónia Magánorvosi Centrum Kft
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Semmelweis Egyetem 1
RECRUITING
Budapest
Semmelweis Egyetem 2
RECRUITING
Budapest
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
RECRUITING
Szeged
India
Sushruta Multispecialty Hospital and Research Centre
RECRUITING
Hubballi
Asian Institute Of Gastroenterology
RECRUITING
Hyderabad
S. R. Kalla Memorial General Hospital
RECRUITING
Jaipur
Lisie Hospital
RECRUITING
Kochi
P D Hinduja National Hospital and Medical Research Center
RECRUITING
Mumbai
Yashoda Super Speciality Hospitals
RECRUITING
Secunderabad
Gujarat Gastro and Vascular Hospital
RECRUITING
Surat
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
RECRUITING
Surat
Israel
Assuta Medical center
RECRUITING
Ashdod
Bnai Zion Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Wolfson Medical Center
RECRUITING
Holon
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
RECRUITING
Milan
Ospedale San Raffaele di Milano
RECRUITING
Milan
Ospedale Sacro Cuore Negrar-Verona
RECRUITING
Negrar-verona
Azienda Ospedaliera San Camillo-Forlanini
RECRUITING
Roma
Fatebenefratelli Isola Tiberina - Gemelli Isola
RECRUITING
Roma
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō City
Hamamatsu University Hospital
RECRUITING
Hamamatsu
National Hospital Organization Hirosaki National Hospital
RECRUITING
Hirosaki
Kagoshima IBD Gastroenterology Clinic
RECRUITING
Kagoshima
Tsujinaka Hospital Kashiwanoha
RECRUITING
Kashiwa
Kobe University Hospital
RECRUITING
Kobe
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Kumamoto University Hospital
RECRUITING
Kumamoto
Takano Hospital
RECRUITING
Kumamoto
Kitasato University Kitasato Institute Hospital
RECRUITING
Minatoku
Kyorin University Hospital
RECRUITING
Mitaka
Nagoya City University Hospital
RECRUITING
Nagoya
Hyogo Medical University Hospital
RECRUITING
Nishinomiya Shi
Japanese Red Cross Osaka Hospital
RECRUITING
Osaka
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
RECRUITING
Sapporo
Sapporo Higashi Tokushukai Hospital
RECRUITING
Sapporo
Sapporo Medical University Hospital
RECRUITING
Sapporo
National Hospital Organization Shizuoka Medical Center
RECRUITING
Shimizu
Takamatsu Red Cross Hospital
RECRUITING
Takamatsu
The Jikei University Hospital
RECRUITING
Tokyo
Yamanashi Prefectural Central Hospital
RECRUITING
Yamanashi
Malaysia
Hospital Ampang
RECRUITING
Ampang
Sultan Idris Shah Hospital
RECRUITING
Kajang
Hospital Queen Elizabeth
RECRUITING
Kota Kinabalu
Hospital Sultanah Nur Zahirah
RECRUITING
Kuala
University Malaya Medical Centre
RECRUITING
Petaling Jaya
Netherlands
Vrije Universiteit Medisch Centrum
RECRUITING
Amsterdam
Radboud Umcn
RECRUITING
Nijmegen
St. Elisabeth Ziekenhuis
RECRUITING
Tilburg
Norway
Alesund sjukehus
RECRUITING
Ålesund
Sykehuset Innlandet HF Gjøvik
RECRUITING
Gjøvik
Akershus Universitetssykehus
RECRUITING
Lorenskog
Sykehuset Ostfold
RECRUITING
Moss
Universitetssykehuset Nord-Norge HF
RECRUITING
Tromsø
St. Olavs Hospital
RECRUITING
Trondheim
Poland
Centrum Medyczne Medis ManerMed Sp Z O O
RECRUITING
Bydgoszcz
Centrum Medyczne Plejady
RECRUITING
Krakow
Centrum Medyczne Promed
RECRUITING
Krakow
Medrise Sp. z o.o.
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
RECRUITING
Lublin
Medicus Zaniewski i Bilski
RECRUITING
Olsztyn
Twoja Przychodnia Opolskie Centrum Medyczne
RECRUITING
Opole
Centrum Medyczne 'Medyk' Sp. z o.o. K.
RECRUITING
Rzeszów
Sonomed Sp. z o.o.
RECRUITING
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
RECRUITING
Torun
H-T Centrum Medyczne
RECRUITING
Tychy
Medical Network
RECRUITING
Warsaw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
EMC Instytut Medyczny S A Penta Hospitals Przychodnie
RECRUITING
Wroclaw
ETG Zamosc
RECRUITING
Zamość
Portugal
Uls Braga - Hosp. Braga
RECRUITING
Braga
Uls Santa Maria - Hosp. Santa Maria
RECRUITING
Lisbon
Uls Algarve Hosp Portimao
RECRUITING
Portimão
Uls Arrabida - Hosp. Sao Bernardo
RECRUITING
Setúbal
Ulsam - Hosp. Santa Luzia
RECRUITING
Viana Do Castelo
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
The Catholic University of Korea Daejeon St Mary's Hospital
RECRUITING
Daejeon
Samsung Medical Center
RECRUITING
Gangnam Gu
Asan Medical Center
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Romania
Baneasa Tumor Center Hospital
RECRUITING
Bucharest
Institutul Clinic Fundeni
RECRUITING
Bucharest
Spitalul Clinic Colentina
RECRUITING
Bucharest
Gastro Med S R L
RECRUITING
Cluj-napoca
Oncohelp Medical Center
RECRUITING
Timișoara
Slovakia
FNsP F. D. Roosevelta Banska Bystrica
RECRUITING
Banská Bystrica
Cliniq s.r.o.
RECRUITING
Bratislava
ENDOMED s.r.o
RECRUITING
Košice
KM Management spol. s r.o.
RECRUITING
Nitra
GASTRO I. s.r.o.
RECRUITING
Prešov
Gastro LM s.r.o.
RECRUITING
Prešov
Ustredna Vojenska Nemocnica SNP Ruzomberok- Fakultna Nemocnica
RECRUITING
Ružomberok
Spain
Hosp. Arquitecto Marcide
RECRUITING
Ferrol
Hosp. de Cabuenes
RECRUITING
Gijón
Hosp. Univ. Infanta Leonor
RECRUITING
Madrid
Hosp. Virgen Macarena
RECRUITING
Seville
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
Hosp. Alvaro Cunqueiro
RECRUITING
Vigo
Switzerland
Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern
RECRUITING
Bern
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan
NTU Biomedical Park Hospital
RECRUITING
Zhubei
Turkey
Antalya Training And Research Hospital
RECRUITING
Antalya
Bezmialem University Medical Faculty
RECRUITING
Istanbul
Marmara University Pendik Training Hospital
RECRUITING
Istanbul
Izmir Sehir Hastanesi
RECRUITING
Izmir
Kocaeli University Medical Faculty
RECRUITING
Kocaeli
Mersin University Medical Faculty
RECRUITING
Mersin
Izmir Katip Celebi University Ataturk Training and Research Hospital
RECRUITING
Turkey
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Cardiff and Vale UHB - University Hospital of Wales
RECRUITING
Cardiff
Ninewells Hospital
RECRUITING
Dundee
Glasgow Royal Infirmary
RECRUITING
Glasgow
Chelsea And Westminster Hospital
RECRUITING
London
Kings College Hospital
RECRUITING
London
St Georges Healthcare NHS Trust
RECRUITING
London
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-05-22
Estimated Completion Date: 2030-07-12
Participants
Target number of participants: 460
Treatments
Experimental: JNJ-78934804
Participants will receive JNJ-78934804 induction dose, at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
Active_comparator: Guselkumab
Participants will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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