Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn’s Disease

Last Updated   April 22, 2019 - 00:00

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OVERVIEW

  • Gender
    both
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    252 sites
  • Status
    Recruiting

SUMMARY

The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn’s disease.

CONDITIONS

  • Crohn Disease

ELIGIBILITY

Inclusion Criteria:

  • • Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
  • • Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram 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, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
  • • A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
  • • Have active Crohn’s disease, defined as a baseline Crohn’s Disease Activity Index (CDAI) score of >= 220 but <= 450 Exclusion Criteria:
  • • Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
  • • Woman who is pregnant or planning pregnancy or is a man who plans to father while randomized in the study or within 16 weeks after the last administration of study agent
  • • Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
  • • Participants with a history of or ongoing chronic or recurrent infectious disease
  • • Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

DETAILS

LOCATIONS

Locations in:
Bulgaria, Germany, Romania, Ukraine, Poland, Canada, Belgium, Hungary, Serbia, Italy, France, Japan, United States, United Kingdom, Russia, South Korea, Czechia
City or Province (252) Country (17) Status
Sofia Medical centre Asklepion Bulgaria
Withdrawn
Sofia UMHAT 'Tsaritsa Yoanna' Bulgaria
Recruiting
Sofia Multiprofile Hospital for Active Treatment - Doverie Bulgaria
Recruiting
Sofia 'St. Ivan Rilski' Hospital Bulgaria
Recruiting
Sofia 2-nd MHAT Bulgaria
Recruiting
Ulm, BW Universitaetsklinikum Ulm Germany
Recruiting
Hannover, NI Medizinische Hochschule Hannover Germany
Recruiting
Kiel, SH Universitatsklinikum Schleswig-Holstein - Kiel Germany
Recruiting
Leipzig Universitatsklinikum Leipzig Germany
Recruiting
Ludwigshafen Praxis Uebel Germany
Recruiting
Hamburg, HH Asklepios Westklinikum Germany
Recruiting
Bucuresti Hyperclinica Medlife Grivita Romania
Recruiting
Oradea Cabinet Medical Dr Fratila Romania
Recruiting
Bucuresti MedLife Grivita Romania
Recruiting
Sumy Komunalnyi zaklad Sumskoi oblasnoi rady “ sumska oblasna kli Ukraine
Recruiting
Uzhgorod Transcarpathian Regional Clinical Hospital Ukraine
Recruiting
Chernivtsi Chernivtsi Regional Clinical Hospital Ukraine
Recruiting
Vinnytsia Vynnitsya City Clinical Hospital #1 Ukraine
Withdrawn
Lviv Lviv National Medical University Ukraine
Recruiting
Kyiv Kyiv City Clinical Hospital No 8 Ukraine
Recruiting
Zhaporozhia Zaporizhzhia Medical University Ukraine
Recruiting
Timisoara Cabinet Particular Policlinic Algomed Romania
Recruiting
Berlin, BE Charité Germany
Recruiting
Sopot, PM Endoskopia Sp z o.o. Poland
Recruiting
Chorzow Przychodnia Medicus sp. z o.o. Poland
Recruiting
Ivano-Frankivsk Ivano Frankivsk National Medical University Ukraine
Recruiting
Bydgoszcz Szpital Uniwersytecki No2 Poland
Recruiting
Bucuresti Euroclinic Hospital Romania
Recruiting
Kyiv BYK-Kiev Ukraine
Withdrawn
Saskatoon, SK Royal University Hospital Canada
Withdrawn
Bruxelles, BRU CHU Saint-Pierre Belgium
Recruiting
Budapest Semmelweis Egyetem Hungary
Recruiting
Leuven UZ Leuven Belgium
Withdrawn
Krakow Centrum medyczne plejady Poland
Withdrawn
Vaughan, ON Toronto Digestive Disease Associates Inc Canada
Withdrawn
Kiyv Kyiv Regional Clinical Hospital Ukraine
Recruiting
Erlangen Universitaetsklinik Erlangen Germany
Withdrawn
Zaporizhzhia KU 6 miska klinichna likarnia ZMR Ukraine
Recruiting
Dnipropetrovsk Dnipropetrovska derzhavna medychna akademiya Ukraine
Recruiting
Kharkiv Kharkiv City Clinical Hospital Ukraine
Recruiting
Hamilton, ON McMaster University Canada
Withdrawn
Bydgoszcz 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Poland
Withdrawn
Lodz Centrum Medyczne Med-Gastr Poland
Recruiting
Krakow Centrum Medyczne Promed Poland
Recruiting
Montreal, QC Montreal General Hospital Canada
Withdrawn
Kharkiv KZOZ Kharkivska miska klinichna likarnia #13 Ukraine
Recruiting
Wroclaw Centrum Medyczne Oporow Poland
Withdrawn
Poznan, WP Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. Poland
Recruiting
Ksawerów Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj Poland
Recruiting
Wloclawek Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska Poland
Recruiting
Lviv Derzhavnyi zaklad Klinichna likarnia DTHO Lvivska zaliznytsia Ukraine
Recruiting
Belgrade Clinical Hospital Center Zvezdara Serbia
Withdrawn
Udine Azienda Ospedaliero Universitaria S.Maria Della Misericordia Italy
Recruiting
Padova University of Padova Italy
Withdrawn
Firenze AOU Careggi Cardiologia Invasiva 1 Italy
Recruiting
Rome Complesso Integrato Columbus Italy
Recruiting
San Giovanni Rotondo Casa Sollievo della Sofferenza Italy
Recruiting
Rozzano Istituto Clinico Humanitas Italy
Recruiting
Torino S.C. Gastroenterologia Italy
Recruiting
Roma Universita Campus Bio Medico[UOC Gastroenterologia] Italy
Recruiting
Genova Università degli studi di Genova Italy
Recruiting
Varna, 03 MHAT 'St. Marina' EAD Bulgaria
Withdrawn
Szczecin Twoja Przychodnia Poland
Recruiting
Palermo Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Italy
Withdrawn
Montreal, QC CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont Canada
Withdrawn
Caen Centre Hospitalier Universitaire (CHU) de Caen France
Withdrawn
Tours CHRU Tours Hôpital Bretonneau France
Withdrawn
Roma Università di Roma La Sapienza Italy
Not yet recruiting
Hyôgo Hyogo College of Medicine Hospital Japan
Not yet recruiting
Lüneburg, NI Städtisches Klinikum Lüneburg Germany
Completed
Luebeck, SH Universitatsklinikum Schleswig-Holstein - Lubeck Germany
Completed
Brescia Fondazione Poliambulanza Istituto Ospedaliero Italy
Not yet recruiting
Lodz Centrum Medyczne AMED oddzial w Lodzi Poland
Completed
Bologna Policlinico Sant'Orsola Malpighi Italy
Completed
Milano Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano Italy
Completed
Trieste Azienda Ospedaliera Universitaria di Cattinara Italy
Not yet recruiting
Liège, WLG CHC-Cliniques Saint-Joseph Belgium
Completed
Bucuresti Centrul Medical SANA Romania
Completed
Gent UZ Gent Belgium
Completed
Roma A.O.U.Policlinico Tor Vergata Italy
Recruiting
Sapporo, 01 Sapporo-Kosei General Hospital Japan
Recruiting
Sendai Sendai Medical Center Japan
Withdrawn
Lille Hopital Claude Huriez France
Not yet recruiting
Marseille Hôpital Nord - Marseille France
Not yet recruiting
Paris HÔPITAL SAINT LOUIS France
Not yet recruiting
Debrecen Vasútegéstségügyi Központ Debrecen Hungary
Completed
Szombathely Markusovszky Egyetemi Oktatokorhaz Hungary
Completed
Amiens CHU Amiens France
Not yet recruiting
London, ON London Health Sciences Centre Canada
Completed
Szekszárd Tolna Megyei Balassa János Kórház Hungary
Completed
Budapest Szent János Kórház és Észak-budai Egyesített Kórházak Hungary
Completed
Osaka Kinshu-kai Infusion Clinic Japan
Recruiting
Kanagawa Matsushima Clinic Japan
Recruiting
Gunma Gunma University Hospital Japan
Recruiting
Osaka-Sayama Kindai University Hospital Japan
Recruiting
Osaka Osaka City University Hospital Japan
Recruiting
Isehara Tokai University Hospital Japan
Not yet recruiting
Essen, NW St Josef Krankenhaus Germany
Completed
Okinawa Urasoe General Hospital Japan
Recruiting
Fukushima Fukushima Medical University Hospital Japan
Not yet recruiting
Brandon, MB Brandon Medical Arts Clinic Canada
Completed
Toulouse CHU Rangueil France
Not yet recruiting
Saint-Etienne Centre hospitalier universitaire de St Etienne France
Not yet recruiting
Bruxelles, BRU HOPITAL ERASME Belgium
Completed
Asahikawa Asahikawa Medical University Hospital Japan
Recruiting
Kanazawa Kanazawa University Hospital Japan
Recruiting
Oswiecim Oswiecimskie Centrum Badan Klinicznych Poland
Recruiting
Zaporizhzhia LLC Diaservis Ukraine
Withdrawn
Kamakura Ofuna Chuo Hospital Japan
Recruiting
Wroclaw EuroMediCare Szpital Specjalistyczny z Przychodnia Poland
Recruiting
Lodz SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia Poland
Recruiting
Saga Saga University Hospital Japan
Recruiting
Ternopil Ternopil University Hospital Ukraine
Recruiting
Kropyvnytskyi PE PMC 'Acinus' Ukraine
Recruiting
Shimotsuke Jichi Medical University Hospital Japan
Recruiting
Kagoshima Kagoshima University Hospital Japan
Recruiting
Bydgoszcz NZOZ Centrum Medyczne KERmed Poland
Recruiting
Sendai Takagi Clinic Japan
Recruiting
Tokyo National Center for Global Health and Medicine Japan
Recruiting
Hamamatsu-Shi Hamamatsu Medical Center Japan
Recruiting
Debrecen Debreceni Egyetem Klinikai Kozpont Hungary
Completed
Kashiwa Medical corporation Kokikai Tsujinaka Hospital Kashiwanoha - Surgery and Coloproctological Surgery Japan
Recruiting
Sendai, 04 Tohoku University Hospital Japan
Recruiting
Nice CHU de Nice Hopital de l Archet France
Not yet recruiting
Pierre-Bénite CENTRE HOSPITALIER LYON SUD France
Not yet recruiting
Shreveport, LA Louisiana Research Center, LLC United States
Completed
London University College Hospital United Kingdom
Not yet recruiting
Coventry, WMD University Hospital Coventry & Warwickshire NHS Trust United Kingdom
Withdrawn
Cambridge, CAM Addenbrookes Hospital United Kingdom
Recruiting
Nottingham, NTT Nottingham University Hospitals NHS Trust United Kingdom
Recruiting
Sankt-Petersburg Elizavetinskaya hospital Russia
Recruiting
Moscow FSBI A.N. Ryzhikh State scientific center of coloproctology of Ministry of Health of Russia Russia
Recruiting
Irkutsk Irkutsk Regional Hospital Russia
Recruiting
St. Petersburg City Clinical Hospital #31 Russia
Withdrawn
Rostov-on-Don City Hospital #20 Russia
Recruiting
Novosibirsk Novosibirsk State Medical University Russia
Recruiting
Saint Petersburg Military Medical Academy Russia
Withdrawn
Moscov GU 'Moscow Regional Research Clinical Institute n.a. M.F.Vla Russia
Recruiting
Moscow GUZ of Moscow Central Research Institute of Gastroenterolog Russia
Completed
Doylestown, PA Central Bucks Specialists-GI United States
Terminated
Suwanee, GA Atlanta Gastroenterology Specialists PC United States
Withdrawn
Cincinnati, OH University of Cincinnati Hospital United States
Terminated
Chicago, IL Rush University Medical Center United States
Recruiting
Cincinnati, OH Consultants for Clinical Research United States
Withdrawn
Columbia, SC Consultants in Gastroenterology United States
Recruiting
Seattle, WA University of Washington United States
Withdrawn
Tyler, TX Digestive Health Specialists United States
Recruiting
Gainesville, FL Florida Research Network, LLC United States
Withdrawn
Seattle, WA Virginia Mason Medical Center United States
Recruiting
Great Neck, NY Long Island Clinical Research Associates/Peak Research LTD United States
Recruiting
Sutton In Ashfield, NTT King'S Mill Hospital United Kingdom
Recruiting
London King's College Hospital United Kingdom
Withdrawn
Nizhny Novgorod Novgorod Regional Clinical Hospital n.a. N.A. Semashko Russia
Recruiting
Suwon-si, 41 The Catholic university of Korea, ST Vincent Hospital South Korea
Terminated
Guri-si, 41 Hanyang University Guri Hospital South Korea
Terminated
Seoul Asan Medical Center South Korea
Recruiting
Seoul Yonsei University College of Medicine South Korea
Recruiting
Seoul Samsung Medical Center South Korea
Withdrawn
Southlake, TX Texas Digestive Disease Consultants United States
Recruiting
Raleigh, NC Wake Research Associates United States
Completed
Louisville, KY University of Louisville United States
Withdrawn
Cleveland, OH University Hospitals Case Medical Center United States
Recruiting
St Petersburg City Clinical Hospital # 26 Russia
Recruiting
Wroclaw Melita Medical Sp. z o.o. Poland
Recruiting
Omsk SEI of HPE “Omsk State Medical University of MinZdrav Russia Russia
Recruiting
Columbia, MD Gastro Center Of Maryland United States
Terminated
Richardson, TX DHAT Research Institute United States
Recruiting
Orlando, FL Florida Hospital United States
Recruiting
Harrow St. Mark's Hospital United Kingdom
Withdrawn
Jacksonville, FL Borland-Groover Clinic United States
Withdrawn
New York, NY Columbia University Medical Center United States
Withdrawn
Salt Lake City, UT University of Utah United States
Recruiting
Rochester, NY University of Rochester Medical Center United States
Recruiting
Gainesville, FL University of Florida United States
Withdrawn
Miami, FL A+ Research, Inc United States
Recruiting
Raleigh, NC Carolina's GI Research United States
Completed
Lone Tree, CO South Denver , PC United States
Terminated
Richmond, VA McGuire Research Institute United States
Recruiting
Madison, WI Dean & St. Mary's Outpatient Center United States
Withdrawn
Charlotte, NC Carolinas Medical Center United States
Completed
Evanston, IL Northshore Universite Healthsystem United States
Recruiting
Bristol, CT Connecticut Gastroenterology Clinical Research Foundation United States
Withdrawn
Fairfax, VA Gastroenterology Associates of Northern Virginia United States
Recruiting
Indianapolis, IN Indianapolis Gastroenterology and Hepatology United States
Completed
Seoul Kangbuk Samsung Hospital South Korea
Recruiting
Daegu Kyungpook National University Hospital South Korea
Recruiting
Busan Dong-A University Hospital South Korea
Completed
Bundang, 41 Seoul National University Bundang Hospital South Korea
Recruiting
Nashville, TN Vanderbilt University Medical Center United States
Recruiting
New York, NY NYU Langone Medical Center United States
Withdrawn
Birmingham, WMD Queen Elizabeth Hospital United Kingdom
Withdrawn
Morristown, NJ Atlantic Digestive Health Institute/ Atlantic IBD Center United States
Recruiting
New York, NY Weill Cornell Medical College United States
Not yet recruiting
New York, NY Mount Sinai Beth Israel United States
Terminated
Miramar, FL FQL Research LLC United States
Terminated
Vandoeuvre-les-Nancy CHU de Nancy_ Hôpital Brabois France
Withdrawn
Houston, TX Baylor College of Medicine United States
Recruiting
Melrose NHS Borders - Borders General Hospital United Kingdom
Withdrawn
Marietta, GA Gastrointestinal Specialists of Georgia United States
Completed
Houston, TX Houston Methodist Hospital United States
Withdrawn
Sheffield, SYK Royal Hallamshire Hospital United Kingdom
Recruiting
Cleveland, OH Cleveland Clinic United States
Withdrawn
Brooklyn, NY NY Scientific United States
Recruiting
London Guys' and St Thomas' NHS Trust United Kingdom
Withdrawn
Lafayette, CO Gastroenterology of the Rockies - Lafayatte United States
Withdrawn
Philadelphia, PA Philadelphia VA Medical Center United States
Withdrawn
Charlottesville, VA University of Virginia United States
Withdrawn
Seattle, WA UW-Harborview Medical Center United States
Withdrawn
St. Augustine, FL East Coast Institute for Research United States
Withdrawn
Greenville, SC Gastroenterology Associates P.A. United States
Recruiting
Coral Gables, FL Research Associates of South Florida,LLC United States
Recruiting
Winter Park, FL Shafran Gastroenterology Center United States
Terminated
Wonju, Gangwon-do, 42 Yonsei University Wonju Severance Christian Hospital South Korea
Withdrawn
Busan Pusan National University Hospital South Korea
Completed
Miami, FL University of Miami United States
Recruiting
St. Petersburg LLC PoliClinic EXPERT Russia
Recruiting
Busan Inje University Haeundae Paik Hospital South Korea
Recruiting
Bethesda, MD Walter Reed National Military Medical Center United States
Withdrawn
Kazan Kazan State Medical University Russia
Recruiting
Palmetto bay, FL IMIC, Inc. United States
Withdrawn
Sankt-Peterburg Northen-Western State Medical University n.a. I.I. Mechnikov Russia
Recruiting
Stanford, CA Stanford Hospital and Clinics United States
Withdrawn
Moscow GUZ of Moscow 'City Clinical Hospital #13' Russia
Recruiting
Samara Medical University Reaviz Russia
Recruiting
Athens, GA Summit Clinical Research, LLC United States
Withdrawn
Asheville, NC Asheville Gastroenterology Associates United States
Withdrawn
Krasnoyarsk KGBUZ 'Regional Clinical Hospital' Russia
Recruiting
Hermitage, TN AIG Research Services United States
Withdrawn
Lake Charles, LA Clinical Trials of SWLA United States
Recruiting
Houma, LA Houma Digestive Health Specialists LLC United States
Recruiting
Boston, MA Massachusetts General Hospital_Boston United States
Withdrawn
Rostov-na-Donu GBOU VPO Rostov State Medical University Russia
Withdrawn
San Antonio, TX Gastroenterology Research of America, LLC United States
Recruiting
Hradec Kralove Hepato-gastroenterologie HK, s.r.o. Czechia
Withdrawn
Heidelberg, BW Universitaetsklinikum Heidelberg Germany
Recruiting
Ekaterinburg Medical Association 'New Hospital' Russia
Recruiting
Saint-Petersburg GUZ CentMedical Hospital #122 n .a. L.G.Sokolov of FMBA Russia
Recruiting
Moscow Stolitsa Medikl Russia
Withdrawn
Ansan-si, 41 Korea University Ansan Hospital South Korea
Recruiting
Tosno Trans regional hospital of Tosno Russia
Recruiting
Minato-ku, 13 Kitasato University Kitasato Institute Hospital Japan
Recruiting
Shinjuku-ku, 13 Tokyo Women's Medical University Hospital Japan
Recruiting
Shinjyuku-ku, 13 Kyorin University Hospital Japan
Not yet recruiting
Sankt-Peterburg LLC BioEq Russia
Recruiting
Chikushino-shi Fukuoka University Chikushi Hospital Japan
Recruiting
Shimotsuga-gun Dokkyo Medical University Hospital Japan
Recruiting
Shinjuku-ku, 13 Tokyo Yamate Medical Center Japan
Recruiting
Seoul Korea University Anam Hospital South Korea
Recruiting
Midori-ku, 11 Tokitokai Tokito Clinic Coloproctology Center Japan
Recruiting
Kahoku-gun Kanazawa Medical University Hospital Japan
Recruiting
Niigata, 15 Niigata University Medical & Dental Hospital Japan
Not yet recruiting
Sakura Toho University Sakura Medical Center Japan
Recruiting
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