A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis (DUET ENCORE-UC)
August 27, 2026 updated by: Janssen Research & Development, LLC
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
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
644
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Study Locations
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AAI, Argentina, C1425BGC
- Recruiting
- GEDYT
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Buenos Aires, Argentina, B1643CRO
- Recruiting
- Instituto Medico De Alta Complejidad (IMAC)
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La Plata, Argentina, 1896
- Recruiting
- Globalpsy
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Mendoza, Argentina, M5500DPS
- Recruiting
- HIGEA
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Quilmes, Argentina, B1878GEG
- Recruiting
- Instituto de Investigaciones Clinicas Quilmes
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San Fernando, Argentina, B1646
- Recruiting
- MR Medicina Reumatologica
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Adelaide, Australia, 5000
- Recruiting
- Banksia Trials SA
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Camperdown, Australia, 2050
- Recruiting
- Royal Prince Alfred Hospital
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Clayton, Australia, 3168
- Recruiting
- Monash Medical Centre
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East Melbourne, Australia, 3002
- Recruiting
- The Melbourne Gut Clinic Epworth Hospital
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Kurralta Park, Australia, 5037
- Recruiting
- SA Gastrointestinal Services
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Murdoch, Australia, 6150
- Recruiting
- Fiona Stanley Hospital
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New Lambton Heights, Australia, 2305
- Recruiting
- John Hunter Hospital
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South Brisbane, Australia, 4101
- Recruiting
- Mater Misericordiae Hospital
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Bonheiden, Belgium, 2820
- Recruiting
- Imelda Bonheiden
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Bruges, Belgium, 8310
- Recruiting
- AZ Sint-Lucas
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Brussels, Belgium, 1090
- Recruiting
- UZ Brussel
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Brussels, Belgium, 1070
- Recruiting
- ULB Erasme Ziekenhuis
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Ghent, Belgium, 9000
- Recruiting
- Ghent University Hospital
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Ghent, Belgium, 9000
- Recruiting
- AZ Maria Middelares
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Leuven, Belgium, 3000
- Recruiting
- Universitair Ziekenhuis Leuven
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Curitiba, Brazil, 80430 180
- Recruiting
- CDC - Centro Digestivo de Curitiba
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Porto Alegre, Brazil, 90035-903
- Recruiting
- Hospital de Clínicas de Porto Alegre
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Porto Alegre, Brazil, 90160-092
- Recruiting
- Hospital Ernesto Dornelles
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Ribeirão Preto, Brazil, 14051140
- Recruiting
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Santo André, Brazil, 09080-110
- Recruiting
- Pesquisare Saude
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São Paulo, Brazil, 01236 030
- Recruiting
- BR Trials
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São Paulo, Brazil, 04077-020
- Recruiting
- Rocco And Nazato Servicos Medicos Ltda
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Votuporanga, Brazil, 15500-269
- Recruiting
- INTEGRAL Pesquisa e Ensino
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Plovdiv, Bulgaria, 4004
- Recruiting
- MHAT Sv. Karidad EAD
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Sofia, Bulgaria, 1407
- Recruiting
- Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
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Sofia, Bulgaria, 1408
- Recruiting
- Diagnostic Consultative Center Neoclinic EAD
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Alberta
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Edmonton, Alberta, Canada, T5R 1W2
- Recruiting
- Gastroenterology and Internal Medicine Research Institute (GIRI)
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Edmonton, Alberta, Canada, Code: T6K 4B2
- Recruiting
- South Edmonton Gastroenterology Research Clinic
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
- Recruiting
- GI Research Institute (G.I.R.I.)
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Nova Scotia
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Kentville, Nova Scotia, Canada, B4N 0A3
- Recruiting
- Viable Clinical Research
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Recruiting
- Barrie GI Associates
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Hamilton, Ontario, Canada, L8N1Y2
- Recruiting
- Charlton Digestive Disease Centre
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London, Ontario, Canada, N6K 1M6
- Recruiting
- London Digestive Disease Institute
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Toronto, Ontario, Canada, M6A 3B4
- Recruiting
- Toronto Immune and Digestive Health Institute Inc
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Quebec
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Montreal, Quebec, Canada, H2X 0C1
- Recruiting
- CHUM - Centre hospitalier universitaire de Montreal
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Montreal, Quebec, Canada, H3H1E3
- Recruiting
- Clinique IMD
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Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
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Beijing, China, 100050
- Recruiting
- Beijing Friendship Hospital Capital Medical University
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Changzhou, China, 213000
- Recruiting
- Changzhou No 2 Peoples Hospital
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Chongqing, China, 400014
- Recruiting
- Chongqing General Hospital
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Guangzhou, China, 510655
- Recruiting
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
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Guangzhou, China, 510080
- Recruiting
- The First Affiliated Hospital Sun Yat sen University
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Huai'an, China, 223300
- Recruiting
- Huai'an 1st Hospital
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Ningbo, China, 315000
- Recruiting
- Ningbo medical center lihuili hospital
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Shijiazhuang, China, 050000
- Recruiting
- The Second Hospital of Hebei Medical University
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Zhuzhou, China, 412007
- Recruiting
- ZhuZhou Central Hospital
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Hradec Kralova, Czechia, 500 02
- Recruiting
- Gastroenterologie, s.r.o., Hradec Kralove
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Hradec Králové, Czechia, 500 12
- Recruiting
- Hepato-gastroenterologie HK, s.r.o.
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Prague, Czechia, 190 00
- Recruiting
- ISCARE a.s.
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Prague, Czechia, 14000
- Recruiting
- Fakultni Thomayerova nemocnice
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České Budějovice, Czechia, 37001
- Recruiting
- Nemocnice Ceske Budejovice a s
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Herlev, Denmark, 2730
- Recruiting
- Herlev Hospital
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Hvidovre, Denmark, 2650
- Recruiting
- Hvidovre Hospital
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Odense, Denmark, 5000
- Recruiting
- Odense University Hospital
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Lille, France, 59037
- Recruiting
- CHU de Lille Hopital Claude Huriez
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Nantes, France, 44000
- Recruiting
- CHU de Nantes hotel Dieu
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Reims, France, 51100
- Recruiting
- CHU de Reims
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Berlin, Germany, 14163
- Recruiting
- Krankenhaus Waldfriede Mitte
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Dresden, Germany, 01307
- Recruiting
- Universitätsklinikum Carl Gustav Carus Dresden
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Hanover, Germany, 30625
- Recruiting
- Medizinische Hochschule Hannover
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Kiel, Germany, 24105
- Recruiting
- Universitatsklinikum Schleswig Holstein Kiel
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Leipzig, Germany, 04103
- Recruiting
- EUGASTRO GmbH
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Mannheim, Germany, 68167
- Recruiting
- Universitaetsklinikum Mannheim
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Rostock, Germany, 18057
- Recruiting
- Universitaetsmedizin Rostock
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Hubballi, India, 580021
- Recruiting
- Sushruta Multispecialty Hospital and Research Centre
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Hyderabad, India, 500032
- Recruiting
- Asian Institute of Gastroenterology
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Jaipur, India, 302006
- Recruiting
- S. R. Kalla Memorial General Hospital
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Kochi, India, 682018
- Recruiting
- Lisie Hospital
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Secunderabad, India, 500003
- Recruiting
- Yashoda Super Speciality Hospitals
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Surat, India, 395002
- Recruiting
- SIDS Hospital & Research Centre
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Surat, India, 395009
- Recruiting
- Gujarat Gastro and Vascular Hospital
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Ashdod, Israel, 7747629
- Recruiting
- Assuta Medical center
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Haifa, Israel, 3109601
- Recruiting
- Rambam Medical Center
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Haifa, Israel, 60910
- Recruiting
- Bnai Zion Medical Center
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Holon, Israel, 5822012
- Recruiting
- Wolfson Medical Center
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Jerusalem, Israel, 9103102
- Recruiting
- Shaare Zedek Medical Center
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Kfar Saba, Israel, 4428164
- Recruiting
- Meir Medical Center
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Nahariya, Israel, 2210001
- Recruiting
- Galilee Medical Center
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Petah Tikva, Israel, 4941492
- Recruiting
- Rabin Medical Center
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Ramat Gan, Israel, 52621
- Recruiting
- Sheba Medical Center
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Tel Aviv, Israel, 64239
- Recruiting
- Tel Aviv Sourasky Medical Center
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Hamamatsu, Japan, 431-3192
- Recruiting
- Hamamatsu University Hospital
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Hamamatsu, Japan, 432-8061
- Recruiting
- Matsuda Hospital
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Higashi-Ibaraki, Japan, 311-3193
- Recruiting
- National Hospital Organization Mito Medical Center
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Kagoshima, Japan, 892-0843
- Recruiting
- Kagoshima IBD Gastroenterology Clinic
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Kashiwa, Japan, 277-0871
- Recruiting
- Tsujinaka Hospital Kashiwanoha
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Kumamoto, Japan, 860-8556
- Recruiting
- Kumamoto University Hospital
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Kumamoto, Japan, 862-0971
- Recruiting
- Takano Hospital
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Minatoku, Japan, 108-8642
- Recruiting
- Kitasato University Kitasato Institute Hospital
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Nagakute, Japan, 480-1195
- Recruiting
- Aichi Medical University Hospital
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Osaka, Japan, 540-0006
- Recruiting
- National Hospital Organization Osaka National Hospital
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Osaka, Japan, 545-8585
- Recruiting
- Osaka Metropolitan University Hospital
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Saga, Japan, 849-8501
- Recruiting
- Saga University Hospital
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Sapporo, Japan, 065-0033
- Recruiting
- Sapporo Higashi Tokushukai Hospital
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Sapporo, Japan, 060-0033
- Recruiting
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
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Shimizu, Japan, 411-8611
- Recruiting
- National Hospital Organization Shizuoka Medical Center
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Shinjuku Ku, Japan, 162 8655
- Recruiting
- Center Hospital of the National Center for Global Health and Medicine
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Sumida Ku, Japan, 130 8575
- Recruiting
- Tokyo Metropolitan Bokutoh Hospital
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Yamanashi, Japan, 400-8506
- Recruiting
- Yamanashi Prefectural Central Hospital
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Ōita, Japan, 870-0033
- Recruiting
- Oita Red Cross Hospital
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Ampang, Malaysia, 68000
- Recruiting
- Hospital Ampang
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Kajang, Malaysia, 43000
- Recruiting
- Sultan Idris Shah Hospital
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Kuala Lumpur, Malaysia, 59100
- Recruiting
- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 50586
- Recruiting
- Hospital Kuala Lumpur
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Kuala Terengganu, Malaysia, 20400
- Recruiting
- Hospital Sultanah Nur Zahirah
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Nijmegen, Netherlands, 6525 GA
- Recruiting
- Radboud Umcn
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Gjøvik, Norway, 2819
- Recruiting
- Sykehuset Innlandet HF Gjøvik
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Tromsø, Norway, 9038
- Recruiting
- Universitetssykehuset Nord-Norge HF
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Trondheim, Norway, 7030
- Recruiting
- St. Olavs Hospital
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Ålesund, Norway, 6017
- Recruiting
- Alesund sjukehus
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Bydgoszcz, Poland, 85 229
- Recruiting
- Centrum Medyczne Medis ManerMed Sp Z O O
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Krakow, Poland, 31-513
- Recruiting
- Centrum Medyczne Promed
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Lublin, Poland, 20 582
- Recruiting
- Medrise Sp. z o.o.
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Rzeszów, Poland, 35-326
- Recruiting
- Centrum Medyczne Medyk
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Szczecin, Poland, 71-434
- Recruiting
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Szczecin, Poland, 71-685
- Recruiting
- Sonomed Sp. z o.o.
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Wroclaw, Poland, 54-239
- Recruiting
- EMC Instytut Medyczny S A Penta Hospitals Przychodnie
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Zamość, Poland, 22 400
- Recruiting
- ETG Zamosc
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Braga, Portugal, 4710 243
- Recruiting
- Uls Braga - Hosp. Braga
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Lisbon, Portugal, 1649 028
- Recruiting
- Uls Santa Maria - Hosp. Santa Maria
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Banská Bystrica, Slovakia, 975 17
- Recruiting
- FNsP F. D. Roosevelta Banska Bystrica
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Bratislava, Slovakia, 811 09
- Recruiting
- Cliniq s.r.o.
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Košice, Slovakia, 040 13
- Recruiting
- ENDOMED s.r.o
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Nitra, Slovakia, 949 01
- Recruiting
- KM Management spol. s r.o.
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Prešov, Slovakia, 080 01
- Recruiting
- GASTRO I. s.r.o.
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Prešov, Slovakia, 080 01
- Recruiting
- Gastro LM s.r.o.
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Busan, South Korea, 48108
- Recruiting
- Inje University Haeundae Paik Hospital
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Daejeon, South Korea, 34943
- Recruiting
- The Catholic University of Korea Daejeon St Mary's Hospital
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Gangnam Gu, South Korea, 06351
- Recruiting
- Samsung Medical Center
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Seoul, South Korea, 05505
- Recruiting
- Asan Medical Center
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Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
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Alicante, Spain, 03010
- Recruiting
- Hosp. Gral. Univ. Dr. Balmis
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Madrid, Spain, 28031
- Recruiting
- Hosp. Univ. Infanta Leonor
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Taipei, Taiwan, 10449
- Recruiting
- Taipei Mackay Memorial Hospital
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Taoyuan, Taiwan, 333
- Recruiting
- Linkou Chang Gung Memorial Hospital
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Antalya, Turkey (Türkiye), 07100
- Recruiting
- Antalya Training And Research Hospital
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Gaziantep, Turkey (Türkiye), 27090
- Recruiting
- Sanko Universitesi Hastanesi
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Istanbul, Turkey (Türkiye), 34098
- Recruiting
- Istanbul University Cerrahpasa Medical Faculty
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Istanbul, Turkey (Türkiye), 34093
- Recruiting
- Bezmialem University Medical Faculty
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Izmir, Turkey (Türkiye), 35540
- Recruiting
- Izmir Sehir Hastanesi
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Kocaeli, Turkey (Türkiye), 41001
- Recruiting
- Kocaeli University Medical Faculty
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Mersin, Turkey (Türkiye), 33343
- Recruiting
- Mersin University Medical Faculty
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London, United Kingdom, SE5 9RS
- Recruiting
- Kings College Hospital
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London, United Kingdom, SW17 0QT
- Recruiting
- St Georges Healthcare NHS Trust
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California
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Anaheim, California, United States, 92805
- Recruiting
- Clinnova Research
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Chula Vista, California, United States, 91910
- Recruiting
- Gastro SB Clinic
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Los Alamitos, California, United States, 90720
- Recruiting
- United Medical Doctors
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San Diego, California, United States, 92123
- Recruiting
- Medical Associates Research Group, Inc.
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Recruiting
- Peak Gastroenterology Associates
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Florida
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Lakewood Rch, Florida, United States, 34211
- Recruiting
- Florida Research Center Inc.
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Miami, Florida, United States, 33157-6575
- Recruiting
- Sanchez Clinical Research, Inc
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Tampa, Florida, United States, 33609
- Recruiting
- GCP Clinical Research
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Georgia
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Suwanee, Georgia, United States, 30024
- Recruiting
- Atlanta Gastroenterology Specialists
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Kentucky
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Crestview Hills, Kentucky, United States, 41017
- Recruiting
- Tri-State Gastroenterology Assoc
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Louisiana
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Lafayette, Louisiana, United States, 70503
- Recruiting
- Gastroenterology Clinic of Acadiana
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Michigan
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Farmington Hills, Michigan, United States, 48334
- Recruiting
- Michigan Center of Medical Research
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New York
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New York, New York, United States, 10075
- Recruiting
- New York Gastroenterology Associates
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Ohio
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Mentor, Ohio, United States, 44060
- Recruiting
- Great Lakes Gastroenterology Research, LLC
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73114
- Recruiting
- Digestive Disease Specialists Inc
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Oregon
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Portland, Oregon, United States, 97220
- Recruiting
- The Oregon Clinic
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Tennessee
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Cordova, Tennessee, United States, 38018
- Recruiting
- Gastro One
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Texas
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San Antonio, Texas, United States, 78229
- Recruiting
- Southern Star Research Institute, LLC
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Tyler, Texas, United States, 75701
- Recruiting
- Tyler Research Institute, LLC
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Washington
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Tacoma, Washington, United States, 98405
- Recruiting
- GI Alliance Tacoma
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
JNJ-78934804 will be administered subcutaneously.
Other Names:
|
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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.
|
Guselkumab will be administered subcutaneously.
Other Names:
JNJ-78934804 will be administered subcutaneously.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants in Clinical Remission at Week 48
Time Frame: At Week 48
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Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.
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At Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants with Endoscopic Improvement at Week 48
Time Frame: At Week 48
|
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
|
At Week 48
|
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Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48
Time Frame: At Week 48
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Corticosteroid-free (90 day) clinical remission is defined as clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.
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At Week 48
|
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Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48
Time Frame: At Week 48
|
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Histologic remission is defined as an absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.
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At Week 48
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Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48
Time Frame: At Week 48
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Fatigue response is defined as a greater than or equal to (>=) 7- point reduction in the patient-reported outcomes measurement information system (PROMIS) fatigue short form 7a total score from baseline.
The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).
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At Week 48
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Percentage of Participants with Sustained Mayo SF Less Than or Equal to (<=) 1 and RB=0
Time Frame: At Weeks 12, 24, and 48
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Percentage of participants with a SF subscore of 0 or 1 and RB subscore of 0 at three assessment time points of Week 12, Week 24, and Week 48 will be reported.
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At Weeks 12, 24, and 48
|
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Percentage of Participants in Abdominal Pain Remission at Week 48
Time Frame: At Week 48
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Percentage of participants in abdominal pain remission at week 48 will be reported.
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At Week 48
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Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48
Time Frame: At Week 48
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IBDQ response is defined as improvement from baseline in the total IBDQ score of >= 16 points.
The IBDQ is a 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
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At Week 48
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Percentage of Participants with PROMIS-29 Mental Component Summary (MCS) Response at Week 48
Time Frame: At Week 48
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PROMIS 29 MCS response is defined as a >= 7-point improvement from baseline in PROMIS 29 MCS response at Week 48.
The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).
The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression/anxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.
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At Week 48
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Percentage of Participants in Clinical Remission at Week 12
Time Frame: At Week 12
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Clinical remission is defined as an SF subscore of 0 or 1, RB subscore of 0, and an endoscopy subscore of 0 or 1.
|
At Week 12
|
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Percentage of Participants with Endoscopic Improvement at Week 12
Time Frame: At Week 12
|
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
|
At Week 12
|
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Percentage of Participants with Mayo SF/RB Response at Week 2
Time Frame: At Week 2
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Mayo SF/RB response is defined as a decrease from baseline in the sum of the SF and the RB subscores by >=30 percent (%) and >= 1 point, with either a >= 1 point decrease from baseline in the RB subscore or an RB subscore of 0 or 1.
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At Week 2
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Percentage of Participants with Adverse Events (AE) and Serious AEs (SAEs)
Time Frame: Up to approximately 3 years
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
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Up to approximately 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2026
Primary Completion (Estimated)
August 11, 2028
Study Completion (Estimated)
October 16, 2030
Study Registration Dates
First Submitted
May 5, 2026
First Submitted That Met QC Criteria
May 5, 2026
First Posted (Actual)
May 11, 2026
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 27, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 78934804UCO3001
- 2026-525923-26-00 (Registry Identifier: EUCT number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.