The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05242471 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
Principal Investigator Affiliation | Janssen Research & Development, LLC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Belgium, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Estonia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Poland, Slovenia, Spain, Sweden, Taiwan, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Crohn's Disease |
Placebo Comparator: Group 1: Placebo
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.
Experimental: Group 2: Guselkumab
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.
Experimental: Group 3: Golimumab
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.
Experimental: Group 4: JNJ-78934804 (High-dose)
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.
Experimental: Group 5: JNJ-78934804 (Mid-dose)
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.
Experimental: Group 6: JNJ-78934804 (Low-dose)
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.
Biological: - Guselkumab
Guselkumab will be administered as subcutaneous injection.
Biological: - Golimumab
Golimumab will be administered as subcutaneous injection.
Biological: - JNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Drug: - Placebo
Placebo will be administered as subcutaneous injection.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama Liver Center
Birmingham, Alabama, 35233
Status
Recruiting
Address
Del Sol Research Management, LLC
Tucson, Arizona, 85715
Status
Recruiting
Address
Moore Clinical Trials, LLC
Little Rock, Arkansas, 72205
Status
Recruiting
Address
Om Research LLC
Apple Valley, California, 92307
Status
Recruiting
Address
Valley Gastroenterology Medical Group
Arcadia, California, 91006
Status
Recruiting
Address
Southern California Research Center
Coronado, California, 92118
Status
Recruiting
Address
Hoag Memorial Hospital
Newport Beach, California, 92658
Status
Recruiting
Address
Medical Associates Research Group, Inc.
San Diego, California, 92123
Status
Recruiting
Address
University of Colorado
Aurora, Colorado, 80045
Status
Recruiting
Address
Medical Research Center of Connecticut
Hamden, Connecticut, 06518
Status
Recruiting
Address
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
Status
Recruiting
Address
Pioneer Research Solutions Inc.
Coconut Creek, Florida, 33066
Status
Recruiting
Address
Homestead Associates in Research, Inc
Homestead, Florida, 33032
Status
Recruiting
Address
Florida Research Center Inc.
Lakewood Ranch, Florida, 34211
Status
Recruiting
Address
Gastroenterology Group Of Naples
Naples, Florida, 34102
Status
Recruiting
Address
Omega Research Consultants
Orlando, Florida, 32808
Status
Recruiting
Address
Synergy Clinical Research
Saint Petersburg, Florida, 33705
Status
Recruiting
Address
University of Mississippi Medical Center
Atlanta, Georgia, 30342
Status
Recruiting
Address
Gastroenterolgy Associates of Central GA
Macon, Georgia, 31201
Status
Recruiting
Address
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Status
Recruiting
Address
IU Health University Hospital
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606
Status
Recruiting
Address
Ascension via Christi Research
Wichita, Kansas, 67208
Status
Recruiting
Address
Univ. of KS School of Med
Wichita, Kansas, 67214-3124
Status
Recruiting
Address
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017
Status
Recruiting
Address
University of Kentucky
Lexington, Kentucky, 40536
Status
Recruiting
Address
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, 70503
Status
Recruiting
Address
Tandem Clinical Research
Marrero, Louisiana, 70072
Status
Recruiting
Address
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Status
Recruiting
Address
Detroit Clinical Research Center
Livonia, Michigan, 48152
Status
Recruiting
Address
Gastrointestinal Associates LLP
Flowood, Mississippi, 39232
Status
Recruiting
Address
Care Access Las Vegas
Las Vegas, Nevada, 89148
Status
Recruiting
Address
A1 Clinical Research
Jackson Heights, New York, 11372
Status
Recruiting
Address
Lenox Hill Hospital
New York, New York, 10075
Status
Recruiting
Address
Mohawk Valley Endoscopy Center
Utica, New York, 13502-6313
Status
Recruiting
Address
University of North Carolina
Chapel Hill, North Carolina, 27599-7080
Status
Recruiting
Address
Tryon Medical Group
Charlotte, North Carolina, 28210
Status
Recruiting
Address
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Status
Recruiting
Address
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145
Status
Recruiting
Address
The Oregon Clinic
Portland, Oregon, 97220-9428
Status
Recruiting
Address
Susquehanna Gastroenterology Associates
Harrisburg, Pennsylvania, 17110-3673
Status
Recruiting
Address
Digestive Disease Associates
Rock Hill, South Carolina, 29732
Status
Recruiting
Address
Galen Medical Group
Hixson, Tennessee, 37343
Status
Recruiting
Address
Etsu Quillen College Of Medicine
Johnson City, Tennessee, 37604
Status
Recruiting
Address
Amel Med LLC. Research
Austin, Texas, 78750
Status
Recruiting
Address
Accurate Clinical Research
Houston, Texas, 77034
Status
Recruiting
Address
Gastroenterology Clinic Of San Antonio P A
San Antonio, Texas, 78229
Status
Recruiting
Address
Digestive Health Specialists
Tyler, Texas, 75701
Status
Recruiting
Address
Care Access Research- Salt Lake City
Salt Lake City, Utah, 84124
Status
Recruiting
Address
University of Virginia
Charlottesville, Virginia, 22908
Status
Recruiting
Address
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
Status
Recruiting
Address
Washington Gastroenterology, PLLC
Bellevue, Washington, 98004
Status
Recruiting
Address
Swedish Medical Center
Seattle, Washington, 98104
Status
Recruiting
Address
University of Washington Digestive Disease Center
Seattle, Washington, 98195
Status
Recruiting
Address
Marshall Health Clinical Research Center
Huntington, West Virginia, 25701
Status
Recruiting
Address
Algemeen Ziekenhuis Delta
Roeselare, , 8800
Status
Recruiting
Address
Vitaz
Sint-Niklaas, ,
Status
Recruiting
Address
MHAT Tzaritza Joanna
Sofia, , 1527
Status
Recruiting
Address
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2
Status
Recruiting
Address
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5
Status
Recruiting
Address
Barrie GI Associates
Barrie, Ontario, L4M 7G1
Status
Recruiting
Address
London Health Sciences Centre
London, Ontario, N6A 5A5
Status
Recruiting
Address
Toronto Immune & Digestive Health Institute Inc.
Toronto, Ontario, M6A 3B4
Status
Recruiting
Address
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Status
Recruiting
Address
Viable Clinical Research
Bridgewater, , B4V 3N2
Status
Recruiting
Address
Changzhou No.2 People's Hospital
Changzhou City, , 213004
Status
Recruiting
Address
West China Hospital, Sichuan University
Chengdu, , 610041
Status
Recruiting
Address
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, , 310016
Status
Recruiting
Address
Shanghai East Hospital
Shanghai, , 200120
Status
Recruiting
Address
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, ,
Status
Recruiting
Address
Zhongshan Hospital, Xiamen University
Xiamen, , 361004
Status
Recruiting
Address
Yangzhou First People's Hospital
Yangzhou, , 225001
Status
Recruiting
Address
ZhuZhou Central Hospital
ZhuZhou, , 412007
Status
Recruiting
Address
Opca bolnica Bjelovar
Bjelovar, , 43000
Status
Recruiting
Address
ISCARE a.s.
Praha 9, , 190 00
Status
Recruiting
Address
Bispebjerg Og Frederiksberg Hospital
Copenhagen, , 2400
Status
Recruiting
Address
West Tallinn Central Hospital
Tallinn, , 10617
Status
Recruiting
Address
Hôpital Nord - Marseille
Marseille, , 13915
Status
Recruiting
Address
CHU de Nice Hopital de l Archet
Nice, , 06202
Status
Recruiting
Address
Centre Hospitalier Lyon Sud
Pierre-Bénite, , 69495
Status
Recruiting
Address
Centre hospitalier universitaire de St Etienne
Saint-Etienne, , 42055
Status
Recruiting
Address
CHU Rangueil
Toulouse, , 31059
Status
Recruiting
Address
Praxis Für Gastroenteroligie
Berlin, , 10825
Status
Recruiting
Address
University Hospital Dresden
Dresden, , 1307
Status
Recruiting
Address
Universitaetsklinik Erlangen
Erlangen, , 91054
Status
Recruiting
Address
Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
Halle Saale, , 06120
Status
Recruiting
Address
Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
Heidelberg, , 69115
Status
Recruiting
Address
Universitätsklinikum Jena
Jena, , 07747
Status
Recruiting
Address
Gastroenterologie Opernstrasse
Kassel, , 34117
Status
Recruiting
Address
Eugastro GmbH
Leipzig, , 04103
Status
Recruiting
Address
MVZ Portal 10
Münster, , 48155
Status
Recruiting
Address
Medius Klinik Nürtingen
Nürtingen, , 72622
Status
Recruiting
Address
Obudai Egeszsegugyi Centrum Kft.
Budapest, , 1036
Status
Recruiting
Address
Semmelweis Egyetem
Budapest, , 1082
Status
Recruiting
Address
Semmelweis Egyetem I.Belgyogyaszati Klinika
Budapest, , 1088
Status
Recruiting
Address
Bugat Pal Korhaz
Gyongyos, , 3200
Status
Recruiting
Address
Szegedi Tudomanyegyetem
Szeged, , H-6720
Status
Recruiting
Address
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , H-9700
Status
Recruiting
Address
Catholic University of Sacred Hearth
Roma, , 00168
Status
Recruiting
Address
Asahikawa Medical University Hospital
Asahikawa, , 078-8510
Status
Recruiting
Address
Fukuoka University Hospital
Fukuoka-shi, , 814-0180
Status
Recruiting
Address
Tokai University Hachioji Hospital
Hachioji, , 192-0032
Status
Recruiting
Address
Hamamatsu University Hospital
Hamamatsu, , 431-3192
Status
Recruiting
Address
National Hospital Organization Hirosaki General Medical Center
Hirosaki, , 036-8545
Status
Recruiting
Address
Hitachi General Hospital
Hitachi, , 317-0077
Status
Recruiting
Address
Hospital of the University of Occupational and Environmental Health
Hukuoka, , 807-8555
Status
Recruiting
Address
Kagoshima IBD Gastroenterology Clinic
Kagoshima, , 892-0843
Status
Recruiting
Address
Tsujinaka Hospital Kashiwanoha
Kashiwa, , 277-0871
Status
Recruiting
Address
Japanese Red Cross Kumamoto Hospital
Kumamoto, , 861-8520
Status
Recruiting
Address
University Hospital Kyoto Perfectural University of Medicine
Kyoto, , 602-8566
Status
Recruiting
Address
Iwate Medical University Hospital
Morioka, , 020-8505
Status
Recruiting
Address
Nagasaki University Hospital
Nagasaki, , 852-8501
Status
Recruiting
Address
Nagoya University Hospital
Nagoya, , 466-8560
Status
Recruiting
Address
Niigata University Medical & Dental Hospital
Niigata, , 951-8520
Status
Recruiting
Address
Kinshukai Infusion Clinic
Osaka, , 530-0011
Status
Recruiting
Address
Saga University Hospital
Saga-shi, , 849-0937
Status
Recruiting
Address
Tokitokai Tokito Clinic Coloproctology Center
Saitama, , 336-0963
Status
Recruiting
Address
Sapporo Tokushukai Hospital
Sapporo, , 004-0041
Status
Recruiting
Address
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, , 060-0033
Status
Recruiting
Address
Sapporo Higashi Tokushukai Hospital
Sapporo, , 065-0033
Status
Recruiting
Address
Tohoku University Hospital
Sendai, , 980-8574
Status
Recruiting
Address
Takamatsu Red Cross Hospital
Takamatsu, , 760-0017
Status
Recruiting
Address
National Center for Global Health and Medicine
Tokyo, , 162-8655
Status
Recruiting
Address
Mie University Hospital
Tsu, , 514-8507
Status
Recruiting
Address
Yokohama City University Medical Center
Yokohama, , 232-0024
Status
Recruiting
Address
Kosin University Gospel Hospital
Busan, , 48108
Status
Recruiting
Address
Kyungpook National University Hospital
Daegu, , 41944
Status
Recruiting
Address
Yeungnam University Hospital
Daegu, , 42415
Status
Recruiting
Address
Dongguk University Ilsan Hospital
Goyang-si, , 10326
Status
Recruiting
Address
Chosun university hospital
Gwangju, , 61453
Status
Recruiting
Address
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , 18450
Status
Recruiting
Address
Kangbuk Samsung Hospital
Seoul, , 03181
Status
Recruiting
Address
Severance Hospital, Yonsei University Health System
Seoul, , 03722
Status
Recruiting
Address
Asan Medical Center
Seoul, , 05505
Status
Recruiting
Address
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , 06273
Status
Recruiting
Address
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, , 06591
Status
Recruiting
Address
Kyung Hee University Hospital
Seoul, , 2447
Status
Recruiting
Address
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, , 6591
Status
Recruiting
Address
Ajou University Hospital
Suwon, , 16499
Status
Recruiting
Address
Hospital Sultanah Bahiyah
Alor Setar, , 5460
Status
Recruiting
Address
Hospital Ampang
Ampang, , 68000
Status
Recruiting
Address
Hospital Pulau Pinang
George Town, , 10990
Status
Recruiting
Address
University Malaya Medical Centre
Kuala Lumpur, , 59100
Status
Recruiting
Address
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, , 1105 AZ
Status
Recruiting
Address
Albert Schweitzer Ziekenhuis
Dordrecht, , 3318 AT
Status
Recruiting
Address
Leiden University Medical Center
Leiden, , 2333 ZA
Status
Recruiting
Address
Erasmus MC
Rotterdam, , 3015 GD
Status
Recruiting
Address
UMC Utrecht
Utrecht, , 3508 GA
Status
Recruiting
Address
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, , 85-168
Status
Recruiting
Address
Centrum Medyczne Plejady
Krakow, , 30-363
Status
Recruiting
Address
Centrum Medyczne Promed
Krakow, , 31-513
Status
Recruiting
Address
AmiCare Centrum Medyczne
Lodz, , 90-644
Status
Recruiting
Address
Gastromed ZOZ
Lublin, , 20-583
Status
Recruiting
Address
Twoja Przychodnia
Poznan, , 61-293
Status
Recruiting
Address
Synexus Polska Sp. z o.o.
Poznan, , 61-441
Status
Recruiting
Address
Centrum Medyczne Medyk
Rzeszow, , 35-326
Status
Recruiting
Address
Sonomed Sp. z o.o.
Szczecin, , 71-685
Status
Recruiting
Address
GASTROMED Sp. z o.o.
Torun, , 87-100
Status
Recruiting
Address
Centrum Zdrowia Matki, Dziecka i Młodzieży
Warszawa, , 00-632
Status
Recruiting
Address
Wojskowy Instytut Medyczny
Warszawa, , 04-141
Status
Recruiting
Address
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Wloclawek, , 87-800
Status
Recruiting
Address
Melita Medical Sp. z o.o.
Wroclaw, , 50-449
Status
Recruiting
Address
Centrum Medyczne Oporow
Wrocław, , 52-416
Status
Recruiting
Address
ETG Zamosc
Zamosc, , 22-400
Status
Recruiting
Address
Splosna bolnisnica Celje
Celje, , 3000
Status
Recruiting
Address
Hosp. Univ. La Paz
Madrid, , 28046
Status
Recruiting
Address
Hosp. de Navarra
Pamplona, , 31008
Status
Recruiting
Address
Hosp. Montecelo
Pontevedra, , 36071
Status
Recruiting
Address
Corporacio Sanitari Parc Tauli
Sabadell, , 8208
Status
Recruiting
Address
Hosp. Univ. Marques de Valdecilla
Santander, , 39008
Status
Recruiting
Address
Hosp. Univ. de Torrejon
Torrejón de Ardoz, , 28850
Status
Recruiting
Address
Universitetssjukhuset Orebro
Orebro, ,
Status
Recruiting
Address
Karolinska University Hospital
Solna, , 17176
Status
Recruiting
Address
China Medical University Hospital
Taichung, , 40447
Status
Recruiting
Address
National Cheng Kung University Hospital
Tainan, , 70403
Status
Recruiting
Address
National Taiwan University Hospital
Taipei, , 100
Status
Recruiting
Address
St George's Healthcare NHS Trust
London, , SW19 0QT
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The Crohn's & Colitis Foundation is a 501(c)(3) non-profit organization dedicated to finding cures for Crohn's disease and ulcerative colitis and improving the quality of life of children and adults affected by these diseases.
Crohn’s & Colitis Foundation es una organización sin fines de lucro 501(c)(3) dedicada a encontrar la cura de la enfermedad de Crohn y la colitis ulcerosa y a mejorar la calidad de vida de las personas afectadas por estas enfermedades.