A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Status: Recruiting
Location: See all (165) 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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
• Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
• An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy
• Have had an inadequate initial response, loss of response, or intolerance to previous 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
Michigan
Michigan Center of Medical Research
RECRUITING
Farmington Hills
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
Southern Star Research Institute, LLC
RECRUITING
San Antonio
Tyler Research Institute, LLC
RECRUITING
Tyler
Washington
GI Alliance Tacoma
RECRUITING
Tacoma
Other Locations
Argentina
GEDYT
RECRUITING
Aai
Instituto Medico De Alta Complejidad (IMAC)
RECRUITING
Buenos Aires
Globalpsy
RECRUITING
La Plata
HIGEA
RECRUITING
Mendoza
Instituto de Investigaciones Clinicas Quilmes
RECRUITING
Quilmes
MR Medicina Reumatologica
RECRUITING
San Fernando
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
RECRUITING
Kurralta Park
Fiona Stanley Hospital
RECRUITING
Murdoch
John Hunter Hospital
RECRUITING
New Lambton Heights
Mater Misericordiae Hospital
RECRUITING
South Brisbane
Belgium
Imelda Bonheiden
RECRUITING
Bonheiden
AZ Sint-Lucas
RECRUITING
Bruges
ULB Erasme Ziekenhuis
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
AZ Maria Middelares
RECRUITING
Ghent
Ghent University Hospital
RECRUITING
Ghent
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Brazil
CDC - Centro Digestivo de Curitiba
RECRUITING
Curitiba
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
INTEGRAL Pesquisa e Ensino
RECRUITING
Votuporanga
Bulgaria
MHAT Sv. Karidad EAD
RECRUITING
Plovdiv
Diagnostic Consultative Center Neoclinic EAD
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
RECRUITING
Sofia
Canada
Barrie GI Associates
RECRUITING
Barrie
Gastroenterology and Internal Medicine Research Institute (GIRI)
RECRUITING
Edmonton
South Edmonton Gastroenterology Research Clinic
RECRUITING
Edmonton
Charlton Digestive Disease Centre
RECRUITING
Hamilton
Viable Clinical Research
RECRUITING
Kentville
London Digestive Disease Institute
RECRUITING
London
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
China
Beijing Friendship Hospital Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
Chongqing General Hospital
RECRUITING
Chongqing
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital Sun Yat sen University
RECRUITING
Guangzhou
Huai'an 1st Hospital
RECRUITING
Huai'an
Ningbo medical center lihuili hospital
RECRUITING
Ningbo
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
ZhuZhou Central Hospital
RECRUITING
Zhuzhou
Denmark
Herlev Hospital
RECRUITING
Herlev
Hvidovre Hospital
RECRUITING
Hvidovre
Odense University Hospital
RECRUITING
Odense
France
CHU de Lille Hopital Claude Huriez
RECRUITING
Lille
CHU de Nantes hotel Dieu
RECRUITING
Nantes
CHU de Reims
RECRUITING
Reims
Germany
Krankenhaus Waldfriede Mitte
RECRUITING
Berlin
Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitatsklinikum Schleswig Holstein Kiel
RECRUITING
Kiel
Eugastro GmbH
RECRUITING
Leipzig
Universitaetsklinikum Mannheim
RECRUITING
Mannheim
Universitaetsmedizin Rostock
RECRUITING
Rostock
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
Yashoda Super Speciality Hospitals
RECRUITING
Secunderabad
Gujarat Gastro and Vascular Hospital
RECRUITING
Surat
SIDS Hospital & 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
Japan
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Matsuda Hospital
RECRUITING
Hamamatsu
National Hospital Organization Mito Medical Center
RECRUITING
Higashi-ibaraki
Kagoshima IBD Gastroenterology Clinic
RECRUITING
Kagoshima
Tsujinaka Hospital Kashiwanoha
RECRUITING
Kashiwa
Kumamoto University Hospital
RECRUITING
Kumamoto
Takano Hospital
RECRUITING
Kumamoto
Kitasato University Kitasato Institute Hospital
RECRUITING
Minatoku
Aichi Medical University Hospital
RECRUITING
Nagakute
Oita Red Cross Hospital
RECRUITING
Ōita
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Saga University Hospital
RECRUITING
Saga
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
RECRUITING
Sapporo
Sapporo Higashi Tokushukai Hospital
RECRUITING
Sapporo
National Hospital Organization Shizuoka Medical Center
RECRUITING
Shimizu
Center Hospital of the National Center for Global Health and Medicine
RECRUITING
Shinjuku Ku
Tokyo Metropolitan Bokutoh Hospital
RECRUITING
Sumida Ku
Yamanashi Prefectural Central Hospital
RECRUITING
Yamanashi
Malaysia
Hospital Ampang
RECRUITING
Ampang
Sultan Idris Shah Hospital
RECRUITING
Kajang
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Sultanah Nur Zahirah
RECRUITING
Kuala Terengganu
Netherlands
Radboud Umcn
RECRUITING
Nijmegen
Norway
Alesund sjukehus
RECRUITING
Ålesund
Sykehuset Innlandet HF Gjøvik
RECRUITING
Gjøvik
Universitetssykehuset Nord-Norge HF
RECRUITING
Tromsø
St. Olavs Hospital
RECRUITING
Trondheim
Poland
Centrum Medyczne Medis ManerMed Sp Z O O
RECRUITING
Bydgoszcz
Centrum Medyczne Promed
RECRUITING
Krakow
Medrise Sp. z o.o.
RECRUITING
Lublin
Centrum Medyczne Medyk
RECRUITING
Rzeszów
Sonomed Sp. z o.o.
RECRUITING
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
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
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
Seoul National University Hospital
RECRUITING
Seoul
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
Spain
Hosp. Gral. Univ. Dr. Balmis
RECRUITING
Alicante
Hosp. Univ. Infanta Leonor
RECRUITING
Madrid
Taiwan
Taipei Mackay Memorial Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Turkey
Antalya Training And Research Hospital
RECRUITING
Antalya
Sanko Universitesi Hastanesi
RECRUITING
Gaziantep
Bezmialem University Medical Faculty
RECRUITING
Istanbul
Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Istanbul
Izmir Sehir Hastanesi
RECRUITING
Izmir
Kocaeli University Medical Faculty
RECRUITING
Kocaeli
Mersin University Medical Faculty
RECRUITING
Mersin
United Kingdom
Kings College Hospital
RECRUITING
London
St Georges Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-05-23
Estimated Completion Date: 2030-10-16
Participants
Target number of participants: 644
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 (DB) treatment phase (Week 48) and 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 with moderately to severely active UC 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 DB treatment phase (Week 48) and 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