A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (DUET-CD)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
- If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion Criteria:
- Complications of CD that may be anticipated to require surgery
- Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
- Has a draining (example, functioning) stoma or ostomy
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
Sites / Locations
- University of Alabama Liver CenterRecruiting
- Del Sol Research Management, LLCRecruiting
- Moore Clinical Trials, LLCRecruiting
- Om Research LLCRecruiting
- Valley Gastroenterology Medical GroupRecruiting
- Southern California Research CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- Hoag Memorial HospitalRecruiting
- Medical Associates Research Group, Inc.Recruiting
- University of ColoradoRecruiting
- Medical Research Center of ConnecticutRecruiting
- MedStar Georgetown University HospitalRecruiting
- Pioneer Research Solutions Inc.Recruiting
- Homestead Associates in Research, IncRecruiting
- Florida Research Center Inc.Recruiting
- Gastroenterology Group Of NaplesRecruiting
- Omega Research ConsultantsRecruiting
- Synergy Clinical ResearchRecruiting
- University of Mississippi Medical CenterRecruiting
- Gastroenterolgy Associates of Central GARecruiting
- Gastrointestinal Specialists of GeorgiaRecruiting
- IU Health University HospitalRecruiting
- Gastroenterology of Southern IndianaRecruiting
- Cotton O'Neil Digestive Health CenterRecruiting
- Ascension via Christi ResearchRecruiting
- Univ. of KS School of MedRecruiting
- Tri-State Gastroenterology AssocRecruiting
- University of KentuckyRecruiting
- Gastroenterology Clinic of AcadianaRecruiting
- Tandem Clinical ResearchRecruiting
- Ochsner Medical CenterRecruiting
- Chevy Chase Clinical ResearchRecruiting
- Brigham & Women's HospitalRecruiting
- FC Research, LLCRecruiting
- Detroit Clinical Research Center
- Gastrointestinal Associates LLPRecruiting
- Care Access Las Vegas
- A1 Clinical ResearchRecruiting
- Weill Cornell Medical CollegeRecruiting
- Lenox Hill HospitalRecruiting
- Mohawk Valley Endoscopy Center
- University of North CarolinaRecruiting
- Tryon Medical GroupRecruiting
- PMG Research of Winston-SalemRecruiting
- University Hospitals Case Medical CenterRecruiting
- Northshore Gastroenterology Research, LLCRecruiting
- The Oregon ClinicRecruiting
- Susquehanna Gastroenterology AssociatesRecruiting
- Medical University of South CarolinaRecruiting
- Digestive Disease AssociatesRecruiting
- Saint Francis HospitalRecruiting
- Galen Medical GroupRecruiting
- Etsu Quillen College Of MedicineRecruiting
- Amel Med LLC. ResearchRecruiting
- Accurate Clinical ResearchRecruiting
- Gastroenterology Clinic Of San Antonio P ARecruiting
- Texas Digestive Disease ConsultantsRecruiting
- Digestive Health SpecialistsRecruiting
- Care Access Research- Salt Lake CityRecruiting
- University of VirginiaRecruiting
- Hunter Holmes McGuire Veterans Affairs Medical CenterRecruiting
- Washington Gastroenterology, PLLCRecruiting
- Swedish Medical CenterRecruiting
- University of Washington Digestive Disease CenterRecruiting
- Digestive Health SpecialistsRecruiting
- Marshall Health Clinical Research CenterRecruiting
- Akh WienRecruiting
- Algemeen Ziekenhuis DeltaRecruiting
- VitazRecruiting
- UMHAT 'Aleksandrovska' EADRecruiting
- MHAT Tzaritza JoannaRecruiting
- Foothills HospitalRecruiting
- Gastroenterology and Internal Medicine Research Institute (GIRI)Recruiting
- University of Alberta HospitalRecruiting
- Fraser Clinical Trials Inc.Recruiting
- GIRI Gastrointestinal Research InstituteRecruiting
- Winnipeg Health Sciences CentreRecruiting
- Viable Clinical ResearchRecruiting
- Nova Scotia Health AuthorityRecruiting
- Barrie GI AssociatesRecruiting
- London Health Sciences CentreRecruiting
- Toronto Immune & Digestive Health Institute Inc.Recruiting
- CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-RosemontRecruiting
- McGill University - Health Centre - Montreal General HospitalRecruiting
- St. Jerome Medical ResearchRecruiting
- CMIIM, Centre médical L'EnjeuRecruiting
- Royal University HospitalRecruiting
- Viable Clinical ResearchRecruiting
- Hopital ChicoutimiRecruiting
- China-Japan Friendship HospitalRecruiting
- The second Xiangya Hospital of Central South UniversityRecruiting
- Changzhou No.2 People's HospitalRecruiting
- West China Hospital, Sichuan UniversityRecruiting
- Chongqing Medical UniversityRecruiting
- The First People's Hospital of FoshanRecruiting
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal HospitalRecruiting
- Guangzhou First Municipal People's HospitalRecruiting
- Nanfang Hospital of Southern Medical HospitalRecruiting
- Hainan General HospitalRecruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
- Jinhua municipal central hospitalRecruiting
- The First Affiliated Hospital of NanChang UniversityRecruiting
- Zhongda Hospital,Southeast UniversityRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Shanghai East HospitalRecruiting
- Ruijin Hospital, Shanghai Jiao Tong UniversityRecruiting
- The Central Hospital of WuhanRecruiting
- Wuhan Union HospitalRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- Wuxi People's HospitalRecruiting
- Zhongshan Hospital, Xiamen UniversityRecruiting
- Yangzhou First People's HospitalRecruiting
- ZhuZhou Central HospitalRecruiting
- Opca bolnica BjelovarRecruiting
- Vojenska nemocnice BrnoRecruiting
- ISCARE a.s.Recruiting
- Aarhus University HospitalRecruiting
- Bispebjerg Og Frederiksberg HospitalRecruiting
- Herlev Hospital, University of CopenhagenRecruiting
- Odense UniversitetshospitalRecruiting
- West Tallinn Central HospitalRecruiting
- Tallinn Children's HospitalRecruiting
- Tartu University HospitalRecruiting
- CHU Amiens - Hopital SudRecruiting
- Centre Hospitalier Universitaire(CHU) - Hopital Henri MondorRecruiting
- Hopital Nord - MarseilleRecruiting
- CHU de Nantes hotel-DieuRecruiting
- Clinique Ambroise PareRecruiting
- CHU de Nice Hopital de l ArchetRecruiting
- Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude VellefauxRecruiting
- Centre Hospitalier Lyon SudRecruiting
- Centre hospitalier universitaire de St EtienneRecruiting
- CHU RangueilRecruiting
- CHRU Nancy-BraboisRecruiting
- Gastroenterologische Spezialpraxis - Berlin-KarlshorstRecruiting
- Praxis Für GastroenteroligieRecruiting
- Charite Campus Benjamin FranklinRecruiting
- Medizinisches Versorgungszentrum (MVZ) DachauRecruiting
- University Hospital DresdenRecruiting
- Universitaetsklinik ErlangenRecruiting
- JWG-University HospitalRecruiting
- Martin-Luther-Universitaet Halle-Wittenberg - UniversitaetskRecruiting
- Medizinische Hochschule HannoverRecruiting
- Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. HemstädRecruiting
- Universitätsklinikum JenaRecruiting
- Praxisgemeinschaft JerichowRecruiting
- Gastroenterologie OpernstrasseRecruiting
- Evangelisches Krankenhaus KalkRecruiting
- Eugastro GmbHRecruiting
- Medizinische Fakultät Mannheim der Universität HeidelbergRecruiting
- Gastroenterologische Gemeinschaftspraxis MindenRecruiting
- Universitätsklinikum MünsterRecruiting
- MVZ Portal 10Recruiting
- Medius Klinik NürtingenRecruiting
- Universitaetsmedizin RostockRecruiting
- Universitätsklinikum TübingenRecruiting
- Universitätsklinikum WürzburgRecruiting
- General Hospital of Athens 'Ippokrateion'Recruiting
- Sotiria General State Hospital of Chest DiseasesRecruiting
- Hippokration HospitalRecruiting
- Obudai Egeszsegugyi Centrum Kft.Recruiting
- Semmelweis EgyetemRecruiting
- Semmelweis Egyetem I.Belgyogyaszati KlinikaRecruiting
- Bugat Pal KorhazRecruiting
- Szegedi TudomanyegyetemRecruiting
- Markusovszky Egyetemi OktatokorhazRecruiting
- AOU Policlinico G.MartinoRecruiting
- Ospedale Specializzato in Gastroenterologia Saverio de BellisRecruiting
- Ospedale Classificato Equiparato Sacro Cuore Don Calabria di NegrarRecruiting
- Catholic University of Sacred HearthRecruiting
- Asahikawa Medical University HospitalRecruiting
- Tokyo Medical and Dental University HospitalRecruiting
- Fukuoka University Chikushi HospitalRecruiting
- Fukuoka University HospitalRecruiting
- Tokai University Hachioji HospitalRecruiting
- Hamamatsu University HospitalRecruiting
- Hirosaki University HospitalRecruiting
- Hitachi General HospitalRecruiting
- Hospital of the University of Occupational and Environmental HealthRecruiting
- The Hospital of Hyogo College of MedicineRecruiting
- Kagoshima University HospitalRecruiting
- Kagoshima IBD Gastroenterology ClinicRecruiting
- Ofuna Chuo HospitalRecruiting
- Tsujinaka Hospital KashiwanohaRecruiting
- Saitama Medical University Saitama Medical CenterRecruiting
- Kyushu Rosai HospitalRecruiting
- Kobe University HospitalRecruiting
- Japanese Red Cross Kumamoto HospitalRecruiting
- Kurume University HospitalRecruiting
- University Hospital Kyoto Perfectural University of MedicineRecruiting
- Kyorin University HospitalRecruiting
- Iwate Medical University HospitalRecruiting
- Nagaoka Red Cross HospitalRecruiting
- Nagasaki University HospitalRecruiting
- Nagoya University HospitalRecruiting
- Niigata University Medical & Dental HospitalRecruiting
- Okayama University HospitalRecruiting
- Kinshukai Infusion ClinicRecruiting
- Osaka City University HospitalRecruiting
- Japan Community Health Care Organization Osaka HospitalRecruiting
- Shiga University of Medical Science HospitalRecruiting
- Saga University HospitalRecruiting
- Tokitokai Tokito Clinic Coloproctology CenterRecruiting
- Sapporo Tokushukai HospitalRecruiting
- Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalRecruiting
- Sapporo Medical University HospitalRecruiting
- Sapporo Higashi Tokushukai HospitalRecruiting
- Tohoku University HospitalRecruiting
- Dokkyo Medical University HospitalRecruiting
- Jichi Medical University HospitalRecruiting
- Tokyo Metropolitan Bokutoh HospitalRecruiting
- Takamatsu Red Cross HospitalRecruiting
- The Jikei University HospitalRecruiting
- Kitasato University Kitasato Institute HospitalRecruiting
- National Center for Global Health and MedicineRecruiting
- Toyama Prefectural Central HospitalRecruiting
- Ieda HospitalRecruiting
- Mie University HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
- Inje University Haeundae Paik HospitalRecruiting
- Kosin University Gospel HospitalRecruiting
- Kyungpook National University HospitalRecruiting
- Yeungnam University HospitalRecruiting
- Dongguk University Ilsan HospitalRecruiting
- Chosun university hospitalRecruiting
- Hallym University Dongtan Sacred Heart HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Kyung Hee University HospitalRecruiting
- Kangbuk Samsung HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Asan Medical CenterRecruiting
- Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
- The Catholic University of Korea, Seoul St.Mary's HospitalRecruiting
- The Catholic University of Korea, Seoul St.Mary's HospitalRecruiting
- Ajou University HospitalRecruiting
- Hospital Sultanah BahiyahRecruiting
- Hospital AmpangRecruiting
- Hospital Pulau PinangRecruiting
- University Malaya Medical CentreRecruiting
- Academisch Medisch Centrum Universiteit van AmsterdamRecruiting
- Albert Schweitzer ZiekenhuisRecruiting
- Leiden University Medical CenterRecruiting
- Maastricht Universitair Medisch CentrumRecruiting
- Erasmus MCRecruiting
- UMC UtrechtRecruiting
- Alesund sjukehusRecruiting
- Akershus UniversitetssykehusRecruiting
- Oslo University Hospital HF Ullevål sykehusRecruiting
- Universitetssykehuset Nord-Norge HFRecruiting
- Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w BydgoszczyRecruiting
- Centrum Medyczne PlejadyRecruiting
- Centrum Medyczne PromedRecruiting
- AmiCare Centrum MedyczneRecruiting
- Gastromed ZOZRecruiting
- Twoja PrzychodniaRecruiting
- Synexus Polska Sp. z o.o.Recruiting
- Centrum Medyczne MedykRecruiting
- Endoskopia Sp z o.o.Recruiting
- Sonomed Sp. z o.o.Recruiting
- GASTROMED Sp. z o.o.Recruiting
- Centrum Zdrowia Matki, Dziecka i MłodzieżyRecruiting
- Centralny Szpital Kliniczny MswiaRecruiting
- Reumatika-Centrum Reumatologii, NZOZRecruiting
- NZOZ VivamedRecruiting
- Wojskowy Instytut MedycznyRecruiting
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny BarskaRecruiting
- Melita Medical Sp. z o.o.Recruiting
- Centrum Medyczne OporowRecruiting
- ETG ZamoscRecruiting
- Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa MariaRecruiting
- Centro Hospitalar Vila Nova de GaiaRecruiting
- KL Ling Gastroenterology and Liver ClinicRecruiting
- Splosna bolnisnica CeljeRecruiting
- Worthwhile Clinical Trials Lakeview HospitalRecruiting
- Inspired GI CareRecruiting
- Clinical Research Centre University of Cape TownRecruiting
- Groote Schur HospitalRecruiting
- Hillcrest privateRecruiting
- Hosp. Univ. La PazRecruiting
- Hosp. de NavarraRecruiting
- Hosp. MonteceloRecruiting
- Corporacio Sanitari Parc TauliRecruiting
- Hosp. Univ. Marques de ValdecillaRecruiting
- Hosp. Univ. de TorrejonRecruiting
- Universitetssjukhuset OrebroRecruiting
- Karolinska University HospitalRecruiting
- INSELSPITAL, Universitätsspital BernRecruiting
- Gastroenterologische Praxis Balsiger und SeiboldRecruiting
- Chang-Hua Christian HospitalRecruiting
- China Medical University HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Glasgow Royal InfirmaryRecruiting
- Queen Elizabeth University HospitalRecruiting
- Velocity Clinical ResearchRecruiting
- Whipps Cross University HospitalRecruiting
- St George's Healthcare NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1: Placebo
Group 2: Guselkumab
Group 3: Golimumab
Group 4: JNJ-78934804 (High-dose)
Group 5: JNJ-78934804 (Mid-dose)
Group 6: JNJ-78934804 (Low-dose)
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.