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Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease (TRIDENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877134
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: JNJ-64304500 Drug: Placebo Drug: Ustekinumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease
Actual Study Start Date : August 25, 2016
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : March 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: Part I : Placebo
Participants will receive placebo Subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. From Week 12 Placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) or CDAI <150) will continue to receive placebo SC injections every 2 weeks from Week 12 through Week 22. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 400 mg SC at Week 12 and then JNJ-64304500 200 mg every two weeks from Week 14 through Week 22.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.

Drug: Placebo
Participants will receive placebo Subcutaneously.

Experimental: Part I : JNJ-64304500
Participants will receive JNJ-64304500 400 milligram (mg) SC at Week 0 then 200 mg SC every two weeks through Week 22.
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.

Experimental: Part II : Placebo
Placebo SC at Weeks 0, 2, 4, and 8. From Week 12, placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in CDAI or CDAI <150) will continue to receive placebo at Weeks 12, 14, 16, and 20. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg at Weeks 14, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive placebo up to 52 weeks (for a total of up to 72 weeks of placebo in Part II).
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.

Drug: Placebo
Participants will receive placebo Subcutaneously.

Experimental: Part II : JNJ-64304500 High Dose
JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 high dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II).
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.

Experimental: Part II : JNJ-64304500 Middle Dose
JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 middle dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II).
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.

Experimental: Part II : JNJ-64304500 Low Dose
JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2, 4, 8, 12, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive JNJ-64304500 low dose up to 52 weeks (for a total of up to 72 weeks of JNJ-64304500 in Part II).
Drug: JNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.

Experimental: Part II : Ustekinumab
Participants will receive tiered doses of Ustekinumab 260 mg (weight <=55 kg), Ustekinumab 390 mg (weight >55 kg and <=85 kg), Ustekinumab 520 mg (weight >85 kg) intravenously at Week 0 followed by 90 mg subcutaneously at Weeks 8 and 16. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive Ustekinumab up to 52 weeks (for a total of up to 72 weeks of Ustekinumab in Part II).
Drug: Ustekinumab
Participants will receive ustekinumab as per the dosing regimen.
Other Name: STELARA




Primary Outcome Measures :
  1. Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 [ Time Frame: Baseline through Week 8 ]
    The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card.

  2. Part II: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12 [ Time Frame: Baseline through Week 12 ]
    The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card.


Secondary Outcome Measures :
  1. Part II: Clinical Remission at Week 12 as Measured by Crohn's Disease Activity Index (CDAI <150) [ Time Frame: Week 12 ]
  2. Part II: Clinical Response at Week 12 as Measured by CDAI (>=100-point reduction from baseline in CDAI or CDAI <150) [ Time Frame: Week 12 ]
  3. Part II: Change in Patient-Reported Outcome (PRO)-2 from baseline at Week 12 [ Time Frame: Baseline through Week 12 ]
    The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score.

  4. Part II: Clinical remission at Week 12 as measured by PRO-2 (PRO-2 <75) [ Time Frame: Week 12 ]
  5. Part II: Clinical response at Week 12 as measured by PRO-2 (>=50-point reduction from baseline in PRO-2 or PRO-2 <75) [ Time Frame: Week 12 ]
  6. Part II: Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline at Week 12 [ Time Frame: Baseline through Week 12 ]
    The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 to 56).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877134


Contacts
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Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

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Locations
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United States, California
Stanford Hospital and Clinics Withdrawn
Stanford, California, United States, 94305
United States, Colorado
Gastroenterology of the Rockies - Lafayatte Withdrawn
Lafayette, Colorado, United States, 80026-2088
South Denver , PC Terminated
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Connecticut Gastroenterology Clinical Research Foundation Withdrawn
Bristol, Connecticut, United States, 06010
United States, Florida
Research Associates of South Florida,LLC Recruiting
Coral Gables, Florida, United States, 33134
Florida Research Network, LLC Withdrawn
Gainesville, Florida, United States, 32605
University of Florida Withdrawn
Gainesville, Florida, United States, 32610
Borland-Groover Clinic Withdrawn
Jacksonville, Florida, United States, 32256
University of Miami Recruiting
Miami, Florida, United States, 33136
A+ Research, Inc Recruiting
Miami, Florida, United States, 33144
FQL Research LLC Terminated
Miramar, Florida, United States, 33025
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
IMIC, Inc. Withdrawn
Palmetto Bay, Florida, United States, 33157
East Coast Institute for Research Withdrawn
Saint Augustine, Florida, United States, 32086
Shafran Gastroenterology Center Terminated
Winter Park, Florida, United States, 32789
United States, Georgia
Summit Clinical Research, LLC Withdrawn
Athens, Georgia, United States, 30607
Gastrointestinal Specialists of Georgia Completed
Marietta, Georgia, United States, 30060
Atlanta Gastroenterology Specialists PC Withdrawn
Suwanee, Georgia, United States, 30024
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Northshore Universite Healthsystem Recruiting
Evanston, Illinois, United States, 60201
United States, Indiana
Indianapolis Gastroenterology and Hepatology Completed
Indianapolis, Indiana, United States, 46237
United States, Kentucky
University of Louisville Withdrawn
Louisville, Kentucky, United States, 40202
United States, Louisiana
Houma Digestive Health Specialists LLC Recruiting
Houma, Louisiana, United States, 70360
Clinical Trials of SWLA Recruiting
Lake Charles, Louisiana, United States, 70601
Louisiana Research Center, LLC Completed
Shreveport, Louisiana, United States, 71103
United States, Maryland
Walter Reed National Military Medical Center Withdrawn
Bethesda, Maryland, United States, 20889-5105
Gastro Center Of Maryland Terminated
Columbia, Maryland, United States, 21045
United States, Massachusetts
Massachusetts General Hospital_Boston Withdrawn
Boston, Massachusetts, United States, 02114
United States, New Jersey
Atlantic Digestive Health Institute/ Atlantic IBD Center Recruiting
Morristown, New Jersey, United States, 07960
United States, New York
NY Scientific Recruiting
Brooklyn, New York, United States, 11235
Long Island Clinical Research Associates/Peak Research LTD Recruiting
Great Neck, New York, United States, 11021
Mount Sinai Beth Israel Terminated
New York, New York, United States, 10003
NYU Langone Medical Center Withdrawn
New York, New York, United States, 10016
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Columbia University Medical Center Withdrawn
New York, New York, United States, 10028
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Asheville Gastroenterology Associates Withdrawn
Asheville, North Carolina, United States, 28801
Carolinas Medical Center Completed
Charlotte, North Carolina, United States, 28204
Carolina's GI Research Completed
Raleigh, North Carolina, United States, 27607
Wake Research Associates Completed
Raleigh, North Carolina, United States, 27612
United States, Ohio
Consultants for Clinical Research Withdrawn
Cincinnati, Ohio, United States, 45219
University of Cincinnati Hospital Terminated
Cincinnati, Ohio, United States, 45267
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Withdrawn
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Central Bucks Specialists-GI Terminated
Doylestown, Pennsylvania, United States, 18901
Philadelphia VA Medical Center Withdrawn
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Consultants in Gastroenterology Recruiting
Columbia, South Carolina, United States, 29203
Gastroenterology Associates P.A. Completed
Greenville, South Carolina, United States, 29615
United States, Tennessee
AIG Research Services Withdrawn
Hermitage, Tennessee, United States, 37076
Vanderbilt University Medical Center Completed
Nashville, Tennessee, United States, 37212-1610
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Houston Methodist Hospital Withdrawn
Houston, Texas, United States, 77030
DHAT Research Institute Recruiting
Richardson, Texas, United States, 75082
Gastroenterology Research of America, LLC Recruiting
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
Digestive Health Specialists Completed
Tyler, Texas, United States, 75701
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132-2410
United States, Virginia
University of Virginia Withdrawn
Charlottesville, Virginia, United States, 22908
Gastroenterology Associates of Northern Virginia Recruiting
Fairfax, Virginia, United States, 22031
McGuire Research Institute Recruiting
Richmond, Virginia, United States, 23249
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
UW-Harborview Medical Center Withdrawn
Seattle, Washington, United States, 98104
University of Washington Withdrawn
Seattle, Washington, United States, 98195
United States, Wisconsin
Dean & St. Mary's Outpatient Center Withdrawn
Madison, Wisconsin, United States, 53715
Belgium
CHU Saint-Pierre Recruiting
Bruxelles, Belgium, 1000
Hopital Erasme Completed
Bruxelles, Belgium, 1070
UZ Gent Completed
Gent, Belgium, 9000
UZ Leuven Withdrawn
Leuven, Belgium, 3000
CHC-Cliniques Saint-Joseph Completed
Liège, Belgium, 4000
Bulgaria
2-nd MHAT Completed
Sofia, Bulgaria, 1202
'St. Ivan Rilski' Hospital Completed
Sofia, Bulgaria, 1431
UMHAT 'Tsaritsa Yoanna' Recruiting
Sofia, Bulgaria, 1527
Medical centre Asklepion Withdrawn
Sofia, Bulgaria, 1606
Multiprofile Hospital for Active Treatment - Doverie Completed
Sofia, Bulgaria, 1632
MHAT 'St. Marina' EAD Withdrawn
Varna, Bulgaria, 9010
Canada, Manitoba
Brandon Medical Arts Clinic Completed
Brandon, Manitoba, Canada, R7A 0N7
Canada, Ontario
McMaster University Withdrawn
Hamilton, Ontario, Canada, L8S 4K1
London Health Sciences Centre Completed
London, Ontario, Canada, N6A 5A5
Toronto Digestive Disease Associates Inc Withdrawn
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont Withdrawn
Montreal, Quebec, Canada, H1T 2M4
Montreal General Hospital Withdrawn
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Royal University Hospital Withdrawn
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czechia
Hepato-gastroenterologie HK, s.r.o. Withdrawn
Hradec Kralove, Czechia, 500 12
France
CHU Amiens Recruiting
Amiens, France, 80054
Centre Hospitalier Universitaire (CHU) de Caen Withdrawn
Caen, France, 14033
Hopital Claude Huriez Recruiting
Lille, France, 59037
Hôpital Nord - Marseille Recruiting
Marseille, France, 13015
CHU de Nice Hopital de l Archet Not yet recruiting
Nice, France, 06202
Hôpital Saint Louis Recruiting
Paris, France, 75475
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Centre hospitalier universitaire de St Etienne Recruiting
Saint-Etienne, France, 42055
CHU Rangueil Recruiting
Toulouse, France, 31059
CHRU Tours Hôpital Bretonneau Withdrawn
Tours, France, 37044
CHU de Nancy_ Hôpital Brabois Withdrawn
Vandoeuvre-les-Nancy, France, 54511
Germany
Charité Recruiting
Berlin, Germany, 13353
Universitaetsklinik Erlangen Withdrawn
Erlangen, Germany, 91054
St Josef Krankenhaus Completed
Essen, Germany, 45257
Asklepios Westklinikum Completed
Hamburg, Germany, 22559
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Universitaetsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Universitatsklinikum Schleswig-Holstein - Kiel Recruiting
Kiel, Germany, 24105
Universitatsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Praxis Uebel Recruiting
Ludwigshafen, Germany, 67067
Universitatsklinikum Schleswig-Holstein - Lubeck Completed
Luebeck, Germany, 23538
Städtisches Klinikum Lüneburg Completed
Lüneburg, Germany, 21339
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Hungary
Semmelweis Egyetem Terminated
Budapest, Hungary, 1088
Szent János Kórház és Észak-budai Egyesített Kórházak Completed
Budapest, Hungary, 1125
Vasútegéstségügyi Központ Debrecen Terminated
Debrecen, Hungary, 4025
Debreceni Egyetem Klinikai Kozpont Terminated
Debrecen, Hungary, H-4032
Tolna Megyei Balassa János Kórház Terminated
Szekszárd, Hungary, 7100
Markusovszky Egyetemi Oktatokorhaz Terminated
Szombathely, Hungary, H-9700
Italy
Policlinico Sant'Orsola Malpighi Completed
Bologna, Italy, 40138
Fondazione Poliambulanza Istituto Ospedaliero Recruiting
Brescia, Italy, 25124
AOU Careggi Cardiologia Invasiva 1 Completed
Firenze, Italy, 50139
Università degli studi di Genova Recruiting
Genova, Italy, 16132
Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano Completed
Milano, Italy, 20122
University of Padova Withdrawn
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Withdrawn
Palermo, Italy, 90127
Universita Campus Bio Medico[UOC Gastroenterologia] Recruiting
Roma, Italy, 00128
A.O.U.Policlinico Tor Vergata Completed
Roma, Italy, 00133
Università di Roma La Sapienza Not yet recruiting
Roma, Italy, 00185
Complesso Integrato Columbus Completed
Rome, Italy, 168
Istituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy, 71013
S.C. Gastroenterologia Completed
Torino, Italy, 10128
Azienda Ospedaliera Universitaria di Cattinara Withdrawn
Trieste, Italy, 34170
Azienda Ospedaliero Universitaria S.Maria Della Misericordia Recruiting
Udine, Italy, 33100
Japan
Asahikawa Medical University Hospital Recruiting
Asahikawa, Japan, 078-8510
Fukuoka University Chikushi Hospital Recruiting
Chikushino-shi, Japan, 818-8502
Fukushima Medical University Hospital Recruiting
Fukushima, Japan, 960-1295
Gunma University Hospital Recruiting
Gunma, Japan, 371-0034
Hamamatsu Medical Center Recruiting
Hamamatsu-Shi, Japan, 431-3192
Hirosaki University Hospital Recruiting
Hirosaki, Japan, 036-8563
Hitachi General Hospital Not yet recruiting
Hitachi, Japan, 317-0077
Hyogo College of Medicine Hospital Recruiting
Hyôgo, Japan, 663-8501
Tokai University Hospital Recruiting
Isehara, Japan, 259-1193
Kagoshima University Hospital Recruiting
Kagoshima, Japan, 890-8520
Kanazawa Medical University Hospital Recruiting
Kahoku-gun, Japan, 920-0293
Ofuna Chuo Hospital Recruiting
Kamakura, Japan, 247-0056
Matsushima Clinic Recruiting
Kanagawa, Japan, 220-0045
Kanazawa University Hospital Recruiting
Kanazawa, Japan, 920-8641
Medical corporation Kokikai Tsujinaka Hospital Kashiwanoha - Surgery and Coloproctological Surgery Recruiting
Kashiwa, Japan, 277-0871
Tokitokai Tokito Clinic Coloproctology Center Recruiting
Midori-ku, Japan, 336-0963
Kitasato University Kitasato Institute Hospital Recruiting
Minato-ku, Japan, 108-8642
Niigata University Medical & Dental Hospital Recruiting
Niigata, Japan, 951-8520
Urasoe General Hospital Recruiting
Okinawa, Japan, 903-0215
Kindai University Hospital Recruiting
Osaka-Sayama, Japan, 589-8511
Kinshu-kai Infusion Clinic Recruiting
Osaka, Japan, 530-0027
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Osaka Rosai Hospital Not yet recruiting
Osaka, Japan, 591-8025
Saga University Hospital Recruiting
Saga, Japan, 849-8501
Toho University Sakura Medical Center Recruiting
Sakura, Japan, 285-8741
Sapporo-Kosei General Hospital Recruiting
Sapporo, Japan, 060-0033
IMS Meirikai Sendai General Hospital Withdrawn
Sendai, Japan, 980-0021
Tohoku University Hospital Recruiting
Sendai, Japan, 980-8574
Takagi Clinic Recruiting
Sendai, Japan, 981-3213
Sendai Medical Center Withdrawn
Sendai, Japan, 983-8520
Dokkyo Medical University Hospital Recruiting
Shimotsuga-gun, Japan, 321-0293
Jichi Medical University Hospital Recruiting
Shimotsuke, Japan, 329-0498
Tokyo Women's Medical University Hospital Recruiting
Shinjuku-ku, Japan, 162-8666
Tokyo Yamate Medical Center Recruiting
Shinjuku-ku, Japan, 169-0073
Kyorin University Hospital Withdrawn
Shinjyuku-ku, Japan, 160-8582
Shizuoka Medical Center Not yet recruiting
Sunto-gun, Japan, 411-8611
National Center for Global Health and Medicine Recruiting
Tokyo, Japan, 162-8655
Korea, Republic of
Korea University Ansan Hospital Terminated
Ansan-si, Korea, Republic of, 15355
Seoul National University Bundang Hospital Completed
Bundang, Korea, Republic of, 463-707
Inje University Haeundae Paik Hospital Completed
Busan, Korea, Republic of, 48108
Pusan National University Hospital Completed
Busan, Korea, Republic of, 49241
Dong-A University Hospital Completed
Busan, Korea, Republic of, 602-812
Kyungpook National University Hospital Completed
Daegu, Korea, Republic of, 41944
Hanyang University Guri Hospital Terminated
Guri-si, Korea, Republic of, 11923
Kangbuk Samsung Hospital Completed
Seoul, Korea, Republic of, 03181
Yonsei University College of Medicine Completed
Seoul, Korea, Republic of, 03722
Asan Medical Center Completed
Seoul, Korea, Republic of, 05505
Samsung Medical Center Withdrawn
Seoul, Korea, Republic of, 06351
Korea University Anam Hospital Completed
Seoul, Korea, Republic of, 136-705
The Catholic university of Korea, ST Vincent Hospital Terminated
Suwon-si, Korea, Republic of, 16247
Yonsei University Wonju Severance Christian Hospital Withdrawn
Wonju, Gangwon-do, Korea, Republic of, 26426
Poland
Szpital Uniwersytecki No2 Recruiting
Bydgoszcz, Poland, 85-168
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Withdrawn
Bydgoszcz, Poland, 85-681
NZOZ Centrum Medyczne KERmed Recruiting
Bydgoszcz, Poland, 85-681
Przychodnia Medicus sp. z o.o. Recruiting
Chorzow, Poland, 41-500
Centrum medyczne plejady Withdrawn
Krakow, Poland, 30-349
Centrum Medyczne Promed Recruiting
Krakow, Poland, 31-411
Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj Recruiting
Ksawerów, Poland, 95-054
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia Recruiting
Lodz, Poland, 90-302
Centrum Medyczne Med-Gastr Completed
Lodz, Poland, 91-034
Centrum Medyczne AMED oddzial w Lodzi Completed
Lodz, Poland, 91-347
Oswiecimskie Centrum Badan Klinicznych Recruiting
Oswiecim, Poland, 32-600
Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k. Recruiting
Poznan, Poland, 60-856
Endoskopia Sp z o.o. Recruiting
Sopot, Poland, 81-756
Twoja Przychodnia Recruiting
Szczecin, Poland, 71-270
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska Recruiting
Wloclawek, Poland, 87-800
EuroMediCare Szpital Specjalistyczny z Przychodnia Recruiting
Wroclaw, Poland, 50-449
Melita Medical Sp. z o.o. Recruiting
Wroclaw, Poland, 50-449
Centrum Medyczne Oporow Withdrawn
Wroclaw, Poland, 52-416
Romania
MedLife Grivita Recruiting
Bucuresti, Romania, 010719
Centrul Medical SANA Completed
Bucuresti, Romania, 011025
Hyperclinica Medlife Grivita Completed
Bucuresti, Romania, 011794
Euroclinic Hospital Recruiting
Bucuresti, Romania, 014461
Cabinet Medical Dr Fratila Recruiting
Oradea, Romania, 410067
Cabinet Particular Policlinic Algomed Recruiting
Timisoara, Romania, 300002
Russian Federation
Medical Association 'New Hospital' Recruiting
Ekaterinburg, Russian Federation, 620109
Irkutsk Regional Hospital Completed
Irkutsk, Russian Federation, 664049
Kazan State Medical University Recruiting
Kazan, Russian Federation, 420012
KGBUZ 'Regional Clinical Hospital' Recruiting
Krasnoyarsk, Russian Federation, 660022
GU 'Moscow Regional Research Clinical Institute n.a. M.F.Vla Recruiting
Moscov, Russian Federation, 129110
GUZ of Moscow Central Research Institute of Gastroenterolog Completed
Moscow, Russian Federation, 111123
GUZ of Moscow 'City Clinical Hospital #13' Recruiting
Moscow, Russian Federation, 115280
FSBI A.N. Ryzhikh State scientific center of coloproctology of Ministry of Health of Russia Recruiting
Moscow, Russian Federation, 123423
Stolitsa Medikl Withdrawn
Moscow, Russian Federation, 129329
Novgorod Regional Clinical Hospital n.a. N.A. Semashko Recruiting
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk State Medical University Recruiting
Novosibirsk, Russian Federation, 630091
SEI of HPE "Omsk State Medical University of MinZdrav Russia Recruiting
Omsk, Russian Federation, 644099
GBOU VPO Rostov State Medical University Withdrawn
Rostov-na-Donu, Russian Federation, 344022
City Hospital #20 Recruiting
Rostov-on-Don, Russian Federation, 344091
Military Medical Academy Withdrawn
Saint Petersburg, Russian Federation, 191015
GUZ CentMedical Hospital #122 n .a. L.G.Sokolov of FMBA Recruiting
Saint-Petersburg, Russian Federation, 194291
Medical University Reaviz Recruiting
Samara, Russian Federation, 443001
LLC BioEq Recruiting
Sankt-Peterburg, Russian Federation, 191015
Northen-Western State Medical University n.a. I.I. Mechnikov Recruiting
Sankt-Peterburg, Russian Federation, 195067
Elizavetinskaya hospital Recruiting
Sankt-Petersburg, Russian Federation, 195257
City Clinical Hospital # 26 Completed
St Petersburg, Russian Federation, 196247
City Clinical Hospital #31 Withdrawn
St. Petersburg, Russian Federation, 197110
LLC PoliClinic EXPERT Recruiting
St. Petersburg, Russian Federation, 197110
Trans regional hospital of Tosno Recruiting
Tosno, Russian Federation, 187000
Serbia
Clinical Hospital Center Zvezdara Withdrawn
Belgrade, Serbia, 11000
Ukraine
Chernivtsi Regional Clinical Hospital Recruiting
Chernivtsi, Ukraine, 58001
Dnipropetrovska derzhavna medychna akademiya Recruiting
Dnipropetrovsk, Ukraine, 49044
Ivano Frankivsk National Medical University Recruiting
Ivano-Frankivsk, Ukraine, 76018
KZOZ Kharkivska miska klinichna likarnia #13 Recruiting
Kharkiv, Ukraine, 61035
Kharkiv City Clinical Hospital Recruiting
Kharkiv, Ukraine, 61037
Kyiv Regional Clinical Hospital Recruiting
Kiyv, Ukraine, 04107
PE PMC 'Acinus' Recruiting
Kropyvnytskyi, Ukraine, 25001
BYK-Kiev Withdrawn
Kyiv, Ukraine, 01030
Kyiv City Clinical Hospital No 8 Recruiting
Kyiv, Ukraine, 01030
Derzhavnyi zaklad Klinichna likarnia DTHO Lvivska zaliznytsia Recruiting
Lviv, Ukraine, 79007
Lviv National Medical University Recruiting
Lviv, Ukraine, 79010
Komunalnyi zaklad Sumskoi oblasnoi rady " sumska oblasna kli Recruiting
Sumy, Ukraine, 40022
Ternopil University Hospital Recruiting
Ternopil, Ukraine, 46002
Transcarpathian Regional Clinical Hospital Recruiting
Uzhgorod, Ukraine, 88000
Vynnitsya City Clinical Hospital #1 Withdrawn
Vinnytsia, Ukraine, 21001
LLC Diaservis Withdrawn
Zaporizhzhia, Ukraine, 69005
KU 6 miska klinichna likarnia ZMR Recruiting
Zaporizhzhia, Ukraine, 69035
Zaporizhzhia Medical University Recruiting
Zhaporozhia, Ukraine, 69000
United Kingdom
Queen Elizabeth Hospital Withdrawn
Birmingham, United Kingdom, B15 2TH
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
University Hospital Coventry & Warwickshire NHS Trust Withdrawn
Coventry, United Kingdom, CV22DX
St. Mark's Hospital Withdrawn
Harrow, United Kingdom, HA1 3UJ
University College Hospital Not yet recruiting
London, United Kingdom, NW1 2PG
Guys' and St Thomas' NHS Trust Withdrawn
London, United Kingdom, SE1 7EH
King's College Hospital Withdrawn
London, United Kingdom, SE59RS
NHS Borders - Borders General Hospital Withdrawn
Melrose, United Kingdom, TD6 9BS
Nottingham University Hospitals NHS Trust Completed
Nottingham, United Kingdom, NG7 2UH
Royal Hallamshire Hospital Completed
Sheffield, United Kingdom, S10 2JF
King'S Mill Hospital Completed
Sutton In Ashfield, United Kingdom, NG17 4JL
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02877134     History of Changes
Other Study ID Numbers: CR108136
64304500CRD2001 ( Other Identifier: Janssen Research & Development, LLC )
2016-000634-21 ( EudraCT Number )
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents