Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease | NCT02877134 | Trialant

Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease | NCT02877134 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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)

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Lone Tree, Colorado, United States

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Coral Gables, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Miramar, Florida, United States

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Orlando, Florida, United States

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Winter Park, Florida, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Indianapolis, Indiana, United States

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Houma, Louisiana, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Columbia, Maryland, United States

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Morristown, New Jersey, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Doylestown, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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Southlake, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Brussels, Belgium

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Ghent, Belgium

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Liège, Belgium

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Sofia, Bulgaria

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Brandon, Manitoba, Canada

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London, Ontario, Canada

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Amiens, France

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Lille, France

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Marseille, France

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Paris, France

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Pierre-Bénite, France

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Saint-Etienne, France

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Toulouse, France

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Berlin, Germany

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Essen, Germany

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Hamburg, Germany

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Hanover, Germany

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Heidelberg, Germany

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Kiel, Germany

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Leipzig, Germany

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Ludwigshafen, Germany

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Lübeck, Germany

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Lüneburg, Germany

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Ulm, Germany

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Budapest, Hungary

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Debrecen, Hungary

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Szekszárd, Hungary

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Szombathely, Hungary

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Asahikawa, Japan

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Chikushino-shi, Japan

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Fukushima, Japan

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Gunma, Japan

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Hamamatsu, Japan

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Hirosaki, Japan

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Hitachi, Japan

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Hyôgo, Japan

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Isehara, Japan

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Kagoshima, Japan

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Kahoku-gun, Japan

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Kamakura, Japan

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Kanagawa, Japan

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Kanazawa, Japan

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Kashiwa, Japan

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Midori-ku, Japan

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Minatoku, Japan

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Niigata, Japan

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Okinawa, Japan

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Osaka, Japan

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Ōsaka-sayama, Japan

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Saga, Japan

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Sakura, Japan

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Sapporo, Japan

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Sendai, Japan

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Shimotsuga Gun, Japan

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Shimotsuke, Japan

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Shinjuku Ku, Japan

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Shinjuku-ku, Japan

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Sunto-gun, Japan

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Bydgoszcz, Poland

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Chorzów, Poland

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Krakow, Poland

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Ksawerów, Poland

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Lodz, Poland

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Oświęcim, Poland

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Poznan, Poland

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Sopot, Poland

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Szczecin, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Włocławek, Poland

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Bucharest, Romania

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Oradea, Romania

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Timișoara, Romania

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Irkutsk, Russia

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Kazan', Russia

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Krasnoyarsk, Russia

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Moscov, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Novosibirsk, Russia

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Omsk, Russia

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Rostov-on-Don, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Tosno, Russia

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Yekaterinburg, Russia

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Bundang, South Korea

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Busan, South Korea

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Daegu, South Korea

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Guri-si, South Korea

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Gyeonggi-do, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Chernivtsi, Ukraine

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Dnipropetrovsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kiyv, Ukraine

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Kropyvnytskyi, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Sumy, Ukraine

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Ternopil, Ukraine

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Uzhhorod, Ukraine

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Zaporizhzhya, Ukraine

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Zhaporozhia, Ukraine

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Cambridge, United Kingdom

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Nottingham, United Kingdom

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Sheffield, United Kingdom

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Sutton in Ashfield, United Kingdom