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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

NCT07577856 · Janssen Research & Development, LLC
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Official title
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
About this study
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 criteria
Inclusion criteria: * 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 Exclusion criteria: * Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD * Has a history of or ongoing chronic or recurrent infectious disease * Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab * Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention
Study design
Enrollment target: 644 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-05-23
Estimated completion: 2030-10-16
Last updated: 2026-08-28
Interventions
Drug: JNJ-78934804Drug: Guselkumab
Primary outcomes
  • Percentage of Participants in Clinical Remission at Week 48 (At Week 48)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (170)
Clinnova ResearchRecruiting
Anaheim, California, United States
Gastro SB ClinicRecruiting
Chula Vista, California, United States
United Medical DoctorsRecruiting
Los Alamitos, California, United States
Medical Associates Research Group, Inc.Recruiting
San Diego, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Florida Research Center Inc.Recruiting
Lakewood Rch, Florida, United States
Sanchez Clinical Research, IncRecruiting
Miami, Florida, United States
GCP Clinical ResearchRecruiting
Tampa, Florida, United States
Atlanta Gastroenterology SpecialistsRecruiting
Suwanee, Georgia, United States
Tri-State Gastroenterology AssocRecruiting
Crestview Hills, Kentucky, United States
Gastroenterology Clinic of AcadianaRecruiting
Lafayette, Louisiana, United States
Michigan Center of Medical ResearchRecruiting
Farmington Hills, Michigan, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
Great Lakes Gastroenterology Research, LLCRecruiting
Mentor, Ohio, United States
Digestive Disease Specialists IncRecruiting
Oklahoma City, Oklahoma, United States
The Oregon ClinicRecruiting
Portland, Oregon, United States
Gastro OneRecruiting
Cordova, Tennessee, United States
Southern Star Research Institute, LLCRecruiting
San Antonio, Texas, United States
Tyler Research Institute, LLCRecruiting
Tyler, Texas, United States
GI Alliance TacomaRecruiting
Tacoma, Washington, United States
GEDYTRecruiting
AAI, Argentina
Instituto Medico De Alta Complejidad (IMAC)Recruiting
Buenos Aires, Argentina
GlobalpsyRecruiting
La Plata, Argentina
HIGEARecruiting
Mendoza, Argentina
Instituto de Investigaciones Clinicas QuilmesRecruiting
Quilmes, Argentina
MR Medicina ReumatologicaRecruiting
San Fernando, Argentina
Banksia Trials SARecruiting
Adelaide, Australia
Royal Prince Alfred HospitalRecruiting
Camperdown, Australia
Monash Medical CentreRecruiting
Clayton, Australia
The Melbourne Gut Clinic Epworth HospitalRecruiting
East Melbourne, Australia
SA Gastrointestinal ServicesRecruiting
Kurralta Park, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Australia
John Hunter HospitalRecruiting
New Lambton Heights, Australia
Mater Misericordiae HospitalRecruiting
South Brisbane, Australia
Imelda BonheidenRecruiting
Bonheiden, Belgium
AZ Sint-LucasRecruiting
Bruges, Belgium
ULB Erasme ZiekenhuisRecruiting
Brussels, Belgium
UZ BrusselRecruiting
Brussels, Belgium
AZ Maria MiddelaresRecruiting
Ghent, Belgium
Ghent University HospitalRecruiting
Ghent, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
CDC - Centro Digestivo de CuritibaRecruiting
Curitiba, Brazil
Hospital De Clinicas De Porto AlegreRecruiting
Porto Alegre, Brazil
Hospital Ernesto DornellesRecruiting
Porto Alegre, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao PretoRecruiting
Ribeirão Preto, Brazil
Pesquisare SaudeRecruiting
Santo André, Brazil
BR TrialsRecruiting
São Paulo, Brazil
Rocco And Nazato Servicos Medicos LtdaRecruiting
São Paulo, Brazil
INTEGRAL Pesquisa e EnsinoRecruiting
Votuporanga, Brazil
MHAT Sv. Karidad EADRecruiting
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'Recruiting
Sofia, Bulgaria
Diagnostic Consultative Center Neoclinic EADRecruiting
Sofia, Bulgaria
South Edmonton Gastroenterology Research ClinicRecruiting
Edmonton, Alberta, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)Recruiting
Edmonton, Alberta, Canada
GI Research Institute (G.I.R.I.)Recruiting
Vancouver, British Columbia, Canada
Viable Clinical ResearchRecruiting
Kentville, Nova Scotia, Canada
Barrie GI AssociatesRecruiting
Barrie, Ontario, Canada
Charlton Digestive Disease CentreRecruiting
Hamilton, Ontario, Canada
London Digestive Disease InstituteRecruiting
London, Ontario, Canada
Toronto Immune and Digestive Health Institute IncRecruiting
Toronto, Ontario, Canada
CHUM - Centre hospitalier universitaire de MontrealRecruiting
Montreal, Quebec, Canada
Clinique IMDRecruiting
Montreal, Quebec, Canada
Beijing Friendship Hospital Capital Medical UniversityRecruiting
Beijing, China
Peking University Third HospitalRecruiting
Beijing, China
Changzhou No 2 Peoples HospitalRecruiting
Changzhou, China
Chongqing General HospitalRecruiting
Chongqing, China
The First Affiliated Hospital Sun Yat sen UniversityRecruiting
Guangzhou, China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal HospitalRecruiting
Guangzhou, China
Huai'an 1st HospitalRecruiting
Huai'an, China
Ningbo medical center lihuili hospitalRecruiting
Ningbo, China
The Second Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, China
ZhuZhou Central HospitalRecruiting
Zhuzhou, China
Nemocnice Ceske Budejovice a sRecruiting
České Budějovice, Czechia
Gastroenterologie, s.r.o., Hradec KraloveRecruiting
Hradec Kralova, Czechia
Hepato-gastroenterologie HK, s.r.o.Recruiting
Hradec Králové, Czechia
Fakultni Thomayerova nemocniceRecruiting
Prague, Czechia
ISCARE a.s.Recruiting
Prague, Czechia
Herlev HospitalRecruiting
Herlev, Denmark
Hvidovre HospitalRecruiting
Hvidovre, Denmark
Odense University HospitalRecruiting
Odense, Denmark
CHU de Lille Hopital Claude HuriezRecruiting
Lille, France
CHU de Nantes hotel DieuRecruiting
Nantes, France
CHU de ReimsRecruiting
Reims, France
Krankenhaus Waldfriede MitteRecruiting
Berlin, Germany
Universitatsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Medizinische Hochschule HannoverRecruiting
Hanover, Germany
Universitatsklinikum Schleswig Holstein KielRecruiting
Kiel, Germany
Eugastro GmbHRecruiting
Leipzig, Germany
Universitaetsklinikum MannheimRecruiting
Mannheim, Germany
Universitaetsmedizin RostockRecruiting
Rostock, Germany
Sushruta Multispecialty Hospital and Research CentreRecruiting
Hubballi, India
Asian Institute Of GastroenterologyRecruiting
Hyderabad, India
S. R. Kalla Memorial General HospitalRecruiting
Jaipur, India
Lisie HospitalRecruiting
Kochi, India
Yashoda Super Speciality HospitalsRecruiting
Secunderabad, India
SIDS Hospital & Research CentreRecruiting
Surat, India
Gujarat Gastro and Vascular HospitalRecruiting
Surat, India
Assuta Medical centerRecruiting
Ashdod, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Bnai Zion Medical CenterRecruiting
Haifa, Israel
Wolfson Medical CenterRecruiting
Holon, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Galilee Medical CenterRecruiting
Nahariya, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Hamamatsu University HospitalRecruiting
Hamamatsu, Japan
Matsuda HospitalRecruiting
Hamamatsu, Japan
National Hospital Organization Mito Medical CenterRecruiting
Higashi-Ibaraki, Japan
Kagoshima IBD Gastroenterology ClinicRecruiting
Kagoshima, Japan
Tsujinaka Hospital KashiwanohaRecruiting
Kashiwa, Japan
Kumamoto University HospitalRecruiting
Kumamoto, Japan
Takano HospitalRecruiting
Kumamoto, Japan
Kitasato University Kitasato Institute HospitalRecruiting
Minatoku, Japan
Aichi Medical University HospitalRecruiting
Nagakute, Japan
National Hospital Organization Osaka National HospitalRecruiting
Osaka, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Oita Red Cross HospitalRecruiting
Ōita, Japan
Saga University HospitalRecruiting
Saga, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalRecruiting
Sapporo, Japan
Sapporo Higashi Tokushukai HospitalRecruiting
Sapporo, Japan
National Hospital Organization Shizuoka Medical CenterRecruiting
Shimizu, Japan
Center Hospital of the National Center for Global Health and MedicineRecruiting
Shinjuku Ku, Japan
Tokyo Metropolitan Bokutoh HospitalRecruiting
Sumida Ku, Japan
Yamanashi Prefectural Central HospitalRecruiting
Yamanashi, Japan
Hospital AmpangRecruiting
Ampang, Malaysia
Sultan Idris Shah HospitalRecruiting
Kajang, Malaysia
Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
University Malaya Medical CentreRecruiting
Kuala Lumpur, Malaysia
Hospital Sultanah Nur ZahirahRecruiting
Kuala Terengganu, Malaysia
Radboud UmcnRecruiting
Nijmegen, Netherlands
Alesund sjukehusRecruiting
Ålesund, Norway
Sykehuset Innlandet HF GjøvikRecruiting
Gjøvik, Norway
Universitetssykehuset Nord-Norge HFRecruiting
Tromsø, Norway
St. Olavs HospitalRecruiting
Trondheim, Norway
Centrum Medyczne Medis ManerMed Sp Z O ORecruiting
Bydgoszcz, Poland
Centrum Medyczne PromedRecruiting
Krakow, Poland
Medrise Sp. z o.o.Recruiting
Lublin, Poland
Centrum Medyczne MedykRecruiting
Rzeszów, Poland
Twoja Przychodnia - Szczecinskie Centrum MedyczneRecruiting
Szczecin, Poland
Sonomed Sp. z o.o.Recruiting
Szczecin, Poland
EMC Instytut Medyczny S A Penta Hospitals PrzychodnieRecruiting
Wroclaw, Poland
ETG ZamoscRecruiting
Zamość, Poland
Uls Braga - Hosp. BragaRecruiting
Braga, Portugal
Uls Santa Maria - Hosp. Santa MariaRecruiting
Lisbon, Portugal
FNsP F. D. Roosevelta Banska BystricaRecruiting
Banská Bystrica, Slovakia
Cliniq s.r.o.Recruiting
Bratislava, Slovakia
ENDOMED s.r.oRecruiting
Košice, Slovakia
KM Management spol. s r.o.Recruiting
Nitra, Slovakia
GASTRO I. s.r.o.Recruiting
Prešov, Slovakia
Gastro LM s.r.o.Recruiting
Prešov, Slovakia
Inje University Haeundae Paik HospitalRecruiting
Busan, South Korea
The Catholic University of Korea Daejeon St Mary's HospitalRecruiting
Daejeon, South Korea
Samsung Medical CenterRecruiting
Gangnam Gu, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Hosp. Gral. Univ. Dr. BalmisRecruiting
Alicante, Spain
Hosp. Univ. Infanta LeonorRecruiting
Madrid, Spain
Taipei Mackay Memorial HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan, Taiwan
Antalya Training And Research HospitalRecruiting
Antalya, Turkey (Türkiye)
Sanko Universitesi HastanesiRecruiting
Gaziantep, Turkey (Türkiye)
Bezmialem University Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Izmir Sehir HastanesiRecruiting
Izmir, Turkey (Türkiye)
Kocaeli University Medical FacultyRecruiting
Kocaeli, Turkey (Türkiye)
Mersin University Medical FacultyRecruiting
Mersin, Turkey (Türkiye)
Kings College HospitalRecruiting
London, United Kingdom
St Georges Healthcare NHS TrustRecruiting
London, United Kingdom
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis · TrialPath