A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
Study Purpose
The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.
Recruitment Criteria
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 - 75 Years |
Gender | All |
Inclusion Criteria:
- - Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450.
- - Have evidence of active ileocolonic Crohn's disease as assessed by an Simplified Endoscopic Score for Crohn's disease (SES-CD) score >=3 at screening by central endoscopy reading; or an elevated screening C-reactive protein (CRP) (greater than [>] 0.3 milligrams per deciliter [mg/dL] or 3.0 milligrams per liter [mg/L]) or an elevated screening fecal calprotectin (>250 micrograms per mg [mcg/mg]) - A participant with a family history of colorectal cancer, personal history of increased risk of colorectal cancer, age > 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).
- - A woman of childbearing potential must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [beta-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0.
- - Has previously demonstrated inadequate response to, loss of response to, or intolerance to an approved biologic therapy (unless otherwise specified in the JNJ-67864238 intervention cohort specific criteria, that is, anti-tumor necrosis factor (TNF) alpha agents (for example, infliximab, adalimumab, certolizumab pegol], anti- interleukin (IL)-12/23 agents [for example, ustekinumab], or anti-integrin agents [for example, vedolizumab]) or has previously demonstrated an inadequate response to or failed to tolerate corticosteroids or immunomodulators (that is, 6-mercaptopurine [6-MP], azathioprine [AZA], and methotrexate [MTX]) but not a biologic, that is, the biologic nonfailures (Bio-NF) population.
- - Therapy for the treatment of Crohn's disease must include at least 1 of the following medications, which should have been maintained at stable doses prior to the baseline (Week 0) visit: (a) Oral 5-aminosalicylic acid (5-ASA) compounds; (b) Oral corticosteroids at a prednisone-equivalent dose <= 25 milligrams per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate; (c) Antibiotics being used as a primary treatment of Crohn's disease; and (d) Conventional immunomodulators (that is, AZA, 6-MP, or MTX) if participants have been taking them for at least 12 weeks and have been at a stable dose for at least 4 weeks prior to baseline.
Exclusion Criteria:
- - Prior exposure to an anti-IL-12/23 or anti-IL-23 antibody or related compound (including ustekinumab, risankizumab, brazikumab, guselkumab, MEDI2070, LY3074828, and related compounds) - Known allergies, hypersensitivity, or intolerance to JNJ-67864238 or its excipients.
- - Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with JNJ-67864238.
- - Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline.
Trial Details
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. |
NCT04102111 |
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 | Argentina, France, Germany, Italy, Poland, Russian Federation, Ukraine, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Crohn Disease |
Study Website: | View Trial Website |
Arms
Experimental: JNJ-67864238
Participants will receive oral tablets of JNJ-67864238 twice daily for 12 weeks.
Placebo Comparator: Placebo
Participants will receive oral tablets of matching placebo twice daily for 12 weeks.
Interventions
Drug: - JNJ-67864238
Participants will receive oral tablets of JNJ-67864238 twice daily.
Drug: - Placebo
Participants will receive oral tablets of matching placebo twice daily.
Contact a Trial Team
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
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920
Status
Completed
Address
Gastro Florida
Clearwater, Florida, 33756
Status
Withdrawn
Address
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Status
Recruiting
Address
Gastroenterology Associates of Central GA
Macon, Georgia, 31201
Status
Completed
Address
CroNOLA, LLC
Houma, Louisiana, 70360
Status
Recruiting
Address
Washington University
Saint Louis, Missouri, 63110
Status
Recruiting
Address
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, 11042
Status
Recruiting
Address
Columbia University Medical Center
New York, New York, 10032
Status
Completed
Address
Great Lakes Medical Research, LLC
Beachwood, Ohio, 44122
Status
Recruiting
Address
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Status
Recruiting
Address
Great Lakes Medical Research, LLC
Westlake, Ohio, 44145
Status
Recruiting
Address
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73112
Status
Recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Status
Withdrawn
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9020
Status
Not yet recruiting
Address
Baylor College of Medicine
Houston, Texas, 77030
Status
Not yet recruiting
Address
Houston Methodist Hospital
Houston, Texas, 77030
Status
Recruiting
Address
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
Status
Withdrawn
Address
University of Washington Medical Center
Seattle, Washington, 98195
International Sites
Status
Withdrawn
Address
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires, , 1431
Status
Recruiting
Address
Cer Instituto Medico
Buenos Aires, , 1878
Status
Withdrawn
Address
Clinica Privada Dim
Buenos Aires, , B1704ETD
Status
Withdrawn
Address
Fundacion Favaloro
Buenos Aires, , C1093AAS
Status
Withdrawn
Address
Hospital Aleman
Buenos Aires, , C1118AAT
Status
Withdrawn
Address
Hospital Italiano de Buenos Aires
Buenos Aires, , C1199ABH
Status
Recruiting
Address
Cinme - Centro De Investigaciones Metabolicas
Caba, , C1027AAP
Status
Withdrawn
Address
Cinme - Centro De Investigaciones Metabolicas
Caba, , C1056ABJ
Status
Recruiting
Address
Clínica Adventista Belgrano
Ciudad De Buenos Aires, , C1430EGF
Status
Withdrawn
Address
Instituto Médico Elsa Pérez I.M.E.P
Ciudadela, , B1702BLP
Status
Recruiting
Address
Sanatorio Duarte Quiroz
Cordoba, , X5002AOQ
Status
Withdrawn
Address
Clinica Universitaria Reina Fabiola
Cordoba, , X5004FHP
Status
Recruiting
Address
Centro de Investigaciones Medicas Mar Del Plata
Mar Del Plata, , B7600FYK
Status
Recruiting
Address
Fundación de Estudios Clínicos
Rosario, , 2000
Status
Withdrawn
Address
Sanatorio de la Mujer
Rosario, , 2000
Status
Withdrawn
Address
Sanatorio 9 de Julio
San Miguel de Tucuman, , 4000
Status
Withdrawn
Address
Sanatorio Vicente Lopez - La Torre
Vicente Lopez, , B1602BWT
Status
Withdrawn
Address
Hôpital Beaujon
Clichy, , 92110
Status
Withdrawn
Address
Hopital Henri Mondor
Creteil, , 94000
Status
Withdrawn
Address
CHRU de Lille - Hôpital Claude Huriez
Lille, , 59037
Status
Withdrawn
Address
Hopital Saint-Louis
Paris, , 75010
Status
Withdrawn
Address
Hospices Civils de Lyon HCL
Pierre Bénite, , 69495
Status
Withdrawn
Address
Hôpital Robert Debré
Reims, , 51092
Status
Withdrawn
Address
CHU Nancy Brabois
Vandoeuvre-Les -nancy, , 54511
Status
Withdrawn
Address
Universitaetsklinikum Charite, Campus Virchow Klinikum
Berlin, , 13353
Status
Recruiting
Address
Universitatsklinikum Schleswig-Holstein - Kiel
Kiel, , 24105
Status
Recruiting
Address
Eugastro GmbH
Leipzig, , 04103
Status
Withdrawn
Address
Universitatsklinikum Leipzig
Leipzig, , 04103
Status
Recruiting
Address
Universitatsklinikum Mannheim
Mannheim, , 68167
Status
Not yet recruiting
Address
Universitätsklinikum Ulm, Klinik für Innere Medizin II
Ulm, , 89081
Status
Recruiting
Address
Policlinico di Bari Ospedale Giovanni XXIII
Bari, ,
Status
Recruiting
Address
Policlinico Sant'Orsola Malpighi
Bologna, , 40138
Status
Recruiting
Address
Azienda Ospedaliera G. Brotzu
Cagliari, , 09134
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Careggi
Firenze, , 50134
Status
Recruiting
Address
Ospedale Policlinico San Martino IRCCS
Genova, , 16132
Status
Withdrawn
Address
AOU Policlinico di Modena
Modena, , 41124
Status
Recruiting
Address
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
Negrar ( Ve), , 37024
Status
Recruiting
Address
Ospedale Maggiore della Carità
Novara, , 28100
Status
Recruiting
Address
Azienda Ospedaliera di Padova
Padova, , 35128
Status
Recruiting
Address
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, , 27100
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Pisana
Pisa, , 56124
Status
Recruiting
Address
Azienda Ospedaliera G.Salvini Ospedale di Rho
RHO, ,
Status
Recruiting
Address
Policinico A Gemelli
Roma, , 00168
Status
Recruiting
Address
Istituto Clinico Humanitas
Rozzano, , 20089
Status
Recruiting
Address
A.O.Citta della Salute e della Scienza di Torino
Torino, , 10126
Status
Withdrawn
Address
AO Ordine Mauriziano
Torino, , 10128
Status
Withdrawn
Address
AOU di Circolo -Fondazione Macchi
Varese, , 21100
Status
Recruiting
Address
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok, , 15-322
Status
Withdrawn
Address
SP ZOZ MSWiA Gdansk
Gdansk, , 80-104
Status
Withdrawn
Address
Malopolskie Centrum Medyczne
Krakow, , 30-510
Status
Withdrawn
Address
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
Lodz, , 90-153
Status
Withdrawn
Address
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
Lodz, , 90-302
Status
Withdrawn
Address
Centrum Medyczne AMED oddzial w Lodzi
Lodz, , 91-363
Status
Withdrawn
Address
Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
Lublin, , 20-583
Status
Recruiting
Address
Endoskopia Sp z o.o.
Sopot, , 81-756
Status
Withdrawn
Address
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, , 71-252
Status
Recruiting
Address
Centralny Szpital Kliniczny Mswia
Warsaw, , 02-507
Status
Withdrawn
Address
NZOZ Vivamed Zespol Lekarzy Specjalistow
Warsaw, , 03-580
Status
Recruiting
Address
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, , 00-728
Status
Withdrawn
Address
Centrum Badawcze Wspolczesnej Terapii
Warszawa, , 02-679
Status
Withdrawn
Address
Centrum Onkologii Klinika Gastroenterologii Onkologicznej
Warszawa, , 02-781
Status
Recruiting
Address
Wojskowy Instytut Medyczny
Warszawa, , 04-349
Status
Withdrawn
Address
Melita Medical Sp. z o.o.
Wroclaw, , 50-449
Status
Withdrawn
Address
LLC Evimed
Chelyabinsk, , 454048
Status
Recruiting
Address
Medical Center Meditsinskie Tekhnologii
Ekaterinburg, , 620075
Status
Recruiting
Address
Immanuel Kant Baltic Federal University
Kaliningrad, , 236016
Status
Recruiting
Address
Kemerovo Region Clinical Hospital
Kemerovo, , 650066
Status
Recruiting
Address
City Hospital #13 of Avtozavodsky
Nizhniy Novgorod, , 603018
Status
Recruiting
Address
Medical Center SibNovoMed LLC
Novosibirsk, , 630005
Status
Withdrawn
Address
Republican Hospital n.a.V.A.Baranov
Petrozavodsk, , 185019
Status
Withdrawn
Address
Rostov State Medical University
Rostov-On-Don, , 344022
Status
Recruiting
Address
Rostov State Medical University (RSMU) based on City Hospital No. 20
Rostov-on-Don, , 344091
Status
Recruiting
Address
City Hospital named after St. Martyr Elizabeth
Saint-Petersburg, , 195257
Status
Recruiting
Address
Non State Healthcare Inst. Railway Clinical Hospital at Samara station JSC 'Russian Railways'
Samara, , 443029
Status
Recruiting
Address
International Medical Centre SOGAZ
St-Petersburg, , 191186
Status
Withdrawn
Address
Consultative and Diagnostic Center 'Endos'
Tyumen, , 625026
Status
Recruiting
Address
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
Ufa, , 450005
Status
Withdrawn
Address
Ulyanovsk Regional Clinical Hospital
Ul'yanovsk, , 432017
Status
Withdrawn
Address
Primorskaya Regional Clinical Hospital#1
Vladivostok, , 690091
Status
Recruiting
Address
Medical diagnostic centre LTD 'MDC'
Yaroslavl, , 150062
Status
Not yet recruiting
Address
Bukovinian State Medical University
Chernivtsi, , 58001
Status
Recruiting
Address
MNCE'City Clinical Hospital №2 named after prof. O.O. Shalimov' of the Kharkiv City Council
Kharkiv, , 61037
Status
Recruiting
Address
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, , 61039
Status
Withdrawn
Address
KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha
Kherson, , 73000
Status
Recruiting
Address
Kyivska miska klinichna likarnia 18
Kyiv, , 01030
Status
Recruiting
Address
Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
Kyiv, , 02000
Status
Withdrawn
Address
Kyiv City Clinical Hospital #6
Kyiv, , 03126
Status
Recruiting
Address
Danylo Halytsky Lviv National Medical University
Lviv, , 79010
Status
Recruiting
Address
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odesa, , 65025
Status
Recruiting
Address
Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council
Ternopil, , 46002
Status
Recruiting
Address
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
Uzhgorod, , 88000
Status
Recruiting
Address
Medical Center Ltd 'Health Clinic'
Vinnytsya, , 21009
Status
Recruiting
Address
VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council
Vinnytsya, ,