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
More Inclusion & Exclusion Criteria

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).
Adenomatous polyps must be removed before the first administration of the study intervention - 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 - Initiation of total (complete) or partial (supplemental) parenteral nutrition administered through any indwelling catheter less than (<) 3 weeks before baseline or anticipated to require parenteral nutrition administered through an indwelling catheter during enrollment in the study

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 & Interventions

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.

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80920

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33756

Atlanta Gastroenterology Associates, Atlanta, Georgia

Status

Not yet recruiting

Address

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342

Macon, Georgia

Status

Recruiting

Address

Gastroenterology Associates of Central GA

Macon, Georgia, 31201

CroNOLA, LLC, Houma, Louisiana

Status

Recruiting

Address

CroNOLA, LLC

Houma, Louisiana, 70360

Washington University, Saint Louis, Missouri

Status

Not yet recruiting

Address

Washington University

Saint Louis, Missouri, 63110

Great Neck, New York

Status

Not yet recruiting

Address

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, 11021

Columbia University Medical Center, New York, New York

Status

Not yet recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Great Lakes Medical Research, LLC, Beachwood, Ohio

Status

Recruiting

Address

Great Lakes Medical Research, LLC

Beachwood, Ohio, 44122

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Great Lakes Medical Research, LLC, Westlake, Ohio

Status

Recruiting

Address

Great Lakes Medical Research, LLC

Westlake, Ohio, 44145

Digestive Disease Specialists Inc, Oklahoma City, Oklahoma

Status

Recruiting

Address

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73112

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Dallas, Texas

Status

Withdrawn

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9020

Baylor College of Medicine, Houston, Texas

Status

Not yet recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Houston Methodist Hospital, Houston, Texas

Status

Not yet recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030

Gastroenterology Research of San Antonio, San Antonio, Texas

Status

Recruiting

Address

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229

University of Washington Medical Center, Seattle, Washington

Status

Not yet recruiting

Address

University of Washington Medical Center

Seattle, Washington, 98195

International Sites

Buenos Aires, Argentina

Status

Withdrawn

Address

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Buenos Aires, , 1431

Cer Instituto Medico, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Cer Instituto Medico

Buenos Aires, , 1878

Clinica Privada Dim, Buenos Aires, Argentina

Status

Withdrawn

Address

Clinica Privada Dim

Buenos Aires, , B1704ETD

Fundacion Favaloro, Buenos Aires, Argentina

Status

Withdrawn

Address

Fundacion Favaloro

Buenos Aires, , C1093AAS

Hospital Aleman, Buenos Aires, Argentina

Status

Withdrawn

Address

Hospital Aleman

Buenos Aires, , C1118AAT

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

Status

Withdrawn

Address

Hospital Italiano de Buenos Aires

Buenos Aires, , C1199ABH

Caba, Argentina

Status

Not yet recruiting

Address

Cinme - Centro De Investigaciones Metabolicas

Caba, , C1027AAP

Caba, Argentina

Status

Withdrawn

Address

Cinme - Centro De Investigaciones Metabolicas

Caba, , C1056ABJ

Clínica Adventista Belgrano, Ciudad De Buenos Aires, Argentina

Status

Not yet recruiting

Address

Clínica Adventista Belgrano

Ciudad De Buenos Aires, , C1430EGF

Instituto Médico Elsa Pérez I.M.E.P, Ciudadela, Argentina

Status

Withdrawn

Address

Instituto Médico Elsa Pérez I.M.E.P

Ciudadela, , B1702BLP

Sanatorio Duarte Quiroz, Cordoba, Argentina

Status

Not yet recruiting

Address

Sanatorio Duarte Quiroz

Cordoba, , X5002AOQ

Clinica Universitaria Reina Fabiola, Cordoba, Argentina

Status

Withdrawn

Address

Clinica Universitaria Reina Fabiola

Cordoba, , X5004FHP

Mar Del Plata, Argentina

Status

Not yet recruiting

Address

Centro de Investigaciones Medicas Mar Del Plata

Mar Del Plata, , B7600FYK

Fundación de Estudios Clínicos, Rosario, Argentina

Status

Not yet recruiting

Address

Fundación de Estudios Clínicos

Rosario, , 2000

Sanatorio de la Mujer, Rosario, Argentina

Status

Withdrawn

Address

Sanatorio de la Mujer

Rosario, , 2000

Sanatorio 9 de Julio, San Miguel de Tucuman, Argentina

Status

Withdrawn

Address

Sanatorio 9 de Julio

San Miguel de Tucuman, , 4000

Sanatorio Vicente Lopez - La Torre, Vicente Lopez, Argentina

Status

Withdrawn

Address

Sanatorio Vicente Lopez - La Torre

Vicente Lopez, , B1602BWT

CHU Amiens, Amiens, France

Status

Withdrawn

Address

CHU Amiens

Amiens, , 80054

Hôpital Beaujon, Clichy, France

Status

Withdrawn

Address

Hôpital Beaujon

Clichy, , 92110

Hopital Henri Mondor, Creteil, France

Status

Withdrawn

Address

Hopital Henri Mondor

Creteil, , 94000

CHRU de Lille - Hôpital Claude Huriez, Lille, France

Status

Withdrawn

Address

CHRU de Lille - Hôpital Claude Huriez

Lille, , 59037

Hopital Saint-Louis, Paris, France

Status

Withdrawn

Address

Hopital Saint-Louis

Paris, , 75010

Hospices Civils de Lyon HCL, Pierre Bénite, France

Status

Withdrawn

Address

Hospices Civils de Lyon HCL

Pierre Bénite, , 69495

Hôpital Robert Debré, Reims, France

Status

Withdrawn

Address

Hôpital Robert Debré

Reims, , 51092

CHU Nancy Brabois, Vandoeuvre-Les -nancy, France

Status

Withdrawn

Address

CHU Nancy Brabois

Vandoeuvre-Les -nancy, , 54511

Berlin, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Charite, Campus Virchow Klinikum

Berlin, , 13353

Kiel, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , 24105

Eugastro GmbH, Leipzig, Germany

Status

Not yet recruiting

Address

Eugastro GmbH

Leipzig, , 04103

Universitatsklinikum Leipzig, Leipzig, Germany

Status

Withdrawn

Address

Universitatsklinikum Leipzig

Leipzig, , 04103

Universitatsklinikum Mannheim, Mannheim, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Mannheim

Mannheim, , 68167

Ulm, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Ulm, Klinik für Innere Medizin II

Ulm, , 89081

Bari, Italy

Status

Not yet recruiting

Address

Policlinico di Bari Ospedale Giovanni XXIII

Bari, ,

Policlinico Sant'Orsola Malpighi, Bologna, Italy

Status

Not yet recruiting

Address

Policlinico Sant'Orsola Malpighi

Bologna, , 40138

Azienda Ospedaliera G. Brotzu, Cagliari, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera G. Brotzu

Cagliari, , 09134

Firenze, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Careggi

Firenze, , 50134

Ospedale Policlinico San Martino IRCCS, Genova, Italy

Status

Not yet recruiting

Address

Ospedale Policlinico San Martino IRCCS

Genova, , 16132

AOU Policlinico di Modena, Modena, Italy

Status

Withdrawn

Address

AOU Policlinico di Modena

Modena, , 41124

Negrar ( Ve), Italy

Status

Not yet recruiting

Address

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

Negrar ( Ve), , 37024

Ospedale Maggiore della Carità, Novara, Italy

Status

Recruiting

Address

Ospedale Maggiore della Carità

Novara, , 28100

Azienda Ospedaliera di Padova, Padova, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera di Padova

Padova, , 35128

Pavia, Italy

Status

Not yet recruiting

Address

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, , 27100

Azienda Ospedaliera Universitaria Pisana, Pisa, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Pisana

Pisa, , 56124

RHO, Italy

Status

Recruiting

Address

Azienda Ospedaliera G.Salvini Ospedale di Rho

RHO, ,

Policinico A Gemelli, Roma, Italy

Status

Recruiting

Address

Policinico A Gemelli

Roma, , 00168

Istituto Clinico Humanitas, Rozzano, Italy

Status

Not yet recruiting

Address

Istituto Clinico Humanitas

Rozzano, , 20089

Torino, Italy

Status

Not yet recruiting

Address

A.O.Citta della Salute e della Scienza di Torino

Torino, , 10126

AO Ordine Mauriziano, Torino, Italy

Status

Withdrawn

Address

AO Ordine Mauriziano

Torino, , 10128

AOU di Circolo -Fondazione Macchi, Varese, Italy

Status

Withdrawn

Address

AOU di Circolo -Fondazione Macchi

Varese, , 21100

Bialystok, Poland

Status

Not yet recruiting

Address

Gastromed Kralisz Romatowski Stachurska Sp. j.

Bialystok, , 15-322

SP ZOZ MSWiA Gdansk, Gdansk, Poland

Status

Withdrawn

Address

SP ZOZ MSWiA Gdansk

Gdansk, , 80-104

Malopolskie Centrum Medyczne, Krakow, Poland

Status

Withdrawn

Address

Malopolskie Centrum Medyczne

Krakow, , 30-510

Lodz, Poland

Status

Withdrawn

Address

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

Lodz, , 90-153

Lodz, Poland

Status

Withdrawn

Address

SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

Lodz, , 90-302

Centrum Medyczne AMED oddzial w Lodzi, Lodz, Poland

Status

Withdrawn

Address

Centrum Medyczne AMED oddzial w Lodzi

Lodz, , 91-363

Lublin, Poland

Status

Withdrawn

Address

Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.

Lublin, , 20-583

Endoskopia Sp z o.o., Sopot, Poland

Status

Recruiting

Address

Endoskopia Sp z o.o.

Sopot, , 81-756

Szczecin, Poland

Status

Withdrawn

Address

Pomorski Uniwersytet Medyczny w Szczecinie

Szczecin, , 71-252

Centralny Szpital Kliniczny Mswia, Warsaw, Poland

Status

Recruiting

Address

Centralny Szpital Kliniczny Mswia

Warsaw, , 02-507

NZOZ Vivamed Zespol Lekarzy Specjalistow, Warsaw, Poland

Status

Withdrawn

Address

NZOZ Vivamed Zespol Lekarzy Specjalistow

Warsaw, , 03-580

WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland

Status

Recruiting

Address

WIP Warsaw IBD Point Profesor Kierkus

Warszawa, , 00-728

Centrum Badawcze Wspolczesnej Terapii, Warszawa, Poland

Status

Withdrawn

Address

Centrum Badawcze Wspolczesnej Terapii

Warszawa, , 02-679

Warszawa, Poland

Status

Withdrawn

Address

Centrum Onkologii Klinika Gastroenterologii Onkologicznej

Warszawa, , 02-781

Wojskowy Instytut Medyczny, Warszawa, Poland

Status

Not yet recruiting

Address

Wojskowy Instytut Medyczny

Warszawa, , 04-349

Melita Medical Sp. z o.o., Wroclaw, Poland

Status

Withdrawn

Address

Melita Medical Sp. z o.o.

Wroclaw, , 50-449

LLC Evimed, Chelyabinsk, Russian Federation

Status

Not yet recruiting

Address

LLC Evimed

Chelyabinsk, , 454048

Medical Center Meditsinskie Tekhnologii, Ekaterinburg, Russian Federation

Status

Not yet recruiting

Address

Medical Center Meditsinskie Tekhnologii

Ekaterinburg, , 620075

Immanuel Kant Baltic Federal University, Kaliningrad, Russian Federation

Status

Not yet recruiting

Address

Immanuel Kant Baltic Federal University

Kaliningrad, , 236016

Kemerovo Region Clinical Hospital, Kemerovo, Russian Federation

Status

Not yet recruiting

Address

Kemerovo Region Clinical Hospital

Kemerovo, , 650066

City Hospital #13 of Avtozavodsky, Nizhniy Novgorod, Russian Federation

Status

Recruiting

Address

City Hospital #13 of Avtozavodsky

Nizhniy Novgorod, , 603018

Medical Center 'SibNovoMed' LLC, Novosibirsk, Russian Federation

Status

Not yet recruiting

Address

Medical Center 'SibNovoMed' LLC

Novosibirsk, , 630005

Republican Hospital n.a.V.A.Baranov, Petrozavodsk, Russian Federation

Status

Not yet recruiting

Address

Republican Hospital n.a.V.A.Baranov

Petrozavodsk, , 185019

Rostov State Medical University, Rostov-On-Don, Russian Federation

Status

Withdrawn

Address

Rostov State Medical University

Rostov-On-Don, , 344022

Rostov-on-Don, Russian Federation

Status

Not yet recruiting

Address

Rostov State Medical University (RSMU) based on City Hospital No. 20

Rostov-on-Don, , 344091

Saint-Petersburg, Russian Federation

Status

Not yet recruiting

Address

City Hospital named after St. Martyr Elizabeth

Saint-Petersburg, , 195257

Samara, Russian Federation

Status

Not yet recruiting

Address

Non State Healthcare Inst. Railway Clinical Hospital at Samara station JSC 'Russian Railways'

Samara, , 443029

International Medical Centre SOGAZ, St-Petersburg, Russian Federation

Status

Not yet recruiting

Address

International Medical Centre SOGAZ

St-Petersburg, , 191186

Tyumen, Russian Federation

Status

Withdrawn

Address

Consultative and Diagnostic Center 'Endos'

Tyumen, , 625026

Ufa, Russian Federation

Status

Not yet recruiting

Address

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

Ufa, , 450005

Ulyanovsk Regional Clinical Hospital, Ul'yanovsk, Russian Federation

Status

Not yet recruiting

Address

Ulyanovsk Regional Clinical Hospital

Ul'yanovsk, , 432017

Primorskaya Regional Clinical Hospital#1, Vladivostok, Russian Federation

Status

Withdrawn

Address

Primorskaya Regional Clinical Hospital#1

Vladivostok, , 690091

Medical diagnostic centre LTD 'MDC', Yaroslavl, Russian Federation

Status

Recruiting

Address

Medical diagnostic centre LTD 'MDC'

Yaroslavl, , 150062

Bukovinian State Medical University, Chernivtsi, Ukraine

Status

Not yet recruiting

Address

Bukovinian State Medical University

Chernivtsi, , 58001

Kharkiv, Ukraine

Status

Not yet recruiting

Address

MNCE'City Clinical Hospital №2 named after prof. O.O. Shalimov' of the Kharkiv City Council

Kharkiv, , 61037

Kharkiv, Ukraine

Status

Not yet recruiting

Address

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

Kharkiv, , 61039

Kherson, Ukraine

Status

Withdrawn

Address

KZ Khersonska Miska Klinichna Likarnia Im. Ye.Ie.Karabelesha

Kherson, , 73000

Kyivska miska klinichna likarnia 18, Kyiv, Ukraine

Status

Not yet recruiting

Address

Kyivska miska klinichna likarnia 18

Kyiv, , 01030

Kyiv, Ukraine

Status

Not yet recruiting

Address

Limited Liability Company 'International Institute of Clinical Research'

Kyiv, , 02000

Kyiv City Clinical Hospital #6, Kyiv, Ukraine

Status

Withdrawn

Address

Kyiv City Clinical Hospital #6

Kyiv, , 03126

Lviv, Ukraine

Status

Not yet recruiting

Address

Danylo Halytsky Lviv National Medical University

Lviv, , 79010

Odesa, Ukraine

Status

Not yet recruiting

Address

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odesa, , 65025

Ternopil, Ukraine

Status

Not yet recruiting

Address

Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council

Ternopil, , 46002

Uzhgorod, Ukraine

Status

Not yet recruiting

Address

MNCE 'Zakarpatska Regional Clinical Hospital named after A. Novak' of Zakarpatska Regional Council

Uzhgorod, , 88000

Health Clinic Limited Liability Company, Vinnytsya, Ukraine

Status

Not yet recruiting

Address

Health Clinic Limited Liability Company

Vinnytsya, , 21021

Vinnytsya, Ukraine

Status

Not yet recruiting

Address

VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

Vinnytsya, ,

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