An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

Sponsors

Lead Sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
Brief Summary

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

Overall Status Recruiting
Start Date 2018-07-16
Completion Date 2024-07-25
Primary Completion Date 2022-09-22
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of participants achieving clinical remission at Week 12 Week 12
Proportion of participants achieving endoscopic response at Week 12 Week 12
Secondary Outcome
Measure Time Frame
Proportion of participants who achieve a clinical response at Week 12 Week 12
Proportion of participants who achieve PRO2 [Participant reported outcome based on the stool frequency and abdominal pain components of the Crohn's Disease Activity Index (CDAI)] remission at Week 12 Week 12
Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12 Week 12
Proportion of participants achieving endoscopic normalization at Week 12 Week 12
Proportion of participants achieving endoscopic remission at Week 12 Week 12
Proportion of participants achieving deep remission at Week 12 Week 12
Enrollment 240
Condition
Intervention

Intervention Type: Drug

Intervention Name: BMS-986165

Description: Specified dose on specified days

Intervention Type: Other

Intervention Name: Placebo

Description: Specified dose on specified days

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: - Documented diagnosis of Crohn's Disease (CD) of at least 3 months' duration, including ileal, colonic, or ileo-colonic disease distribution - Must have active moderate to severe CD - Men and women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Severe or fulminant colitis that is likely to require surgery or hospitalization - Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease - Previous exposure to BMS-986165 in any study - Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant Other protocol-defined inclusion/exclusion criteria apply

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Overall Contact

Last Name: BMS Study Connect Contact Center www.BMSStudyConnect.com

Phone: 855-907-3286

Email: [email protected]

Location
Facility: Status: Contact:
GastroIntestinal Biosciences | Los Angeles, California, 90067-2015, United States Recruiting Nicholas Karyotakis, Site 0258 310-766-2079
Local Institution | Los Angeles, California, 90095, United States Withdrawn
Local Institution | San Diego, California, 92114, United States Withdrawn
Kaiser Permanente Colorado Institute for Health Research | Aurora, Colorado, 80014, United States Recruiting Christopher Shepela, Site 0247
The Medical Research Center of Connecticut | Hamden, Connecticut, 06518, United States Recruiting Philip Ginsburg, Site 0001 203-281-5161
Gastro Florida | Clearwater, Florida, 33756-3839, United States Recruiting Lawrence Michael Weiss, Site 0255
University of Florida Health - Jacksonville | Jacksonville, Florida, 32207-4958, United States Recruiting Maged Ghali, Site 0259 904-633-0177
Mayo Clinic - Jacksonville | Jacksonville, Florida, 32224, United States Recruiting Francis Farraye, Site 0261 617-541-6470
Local Institution | Lakewood Ranch, Florida, 34211, United States Withdrawn
Florida Center for Gastroenterology | Largo, Florida, 33777, United States Active, not recruiting
University of Miami Miller School of Medicine | Miami, Florida, 33136, United States Recruiting Maria Abreu, Site 0232
Advanced Research Institute - New Port Richey | New Port Richey, Florida, 34653, United States Recruiting Curtis Freedland, Site 0162 727-835-3261
Omega Research Consultants - Maitland | Orlando, Florida, 32808, United States Recruiting Kwabena Ayesu, Site 0201 386-668-4202
Florida Hospital Orlando | Orlando, Florida, 32832, United States Recruiting Muhammad Hasan, Site 0249 407-609-3947
Local Institution | Palmetto Bay, Florida, 33157, United States Withdrawn
Local Institution - 0166 | Tampa, Florida, 33606, United States Completed
Florida Medical Clinic - Clinical Research Division | Zephyrhills, Florida, 33542, United States Recruiting Tawfik Chami, Site 0248 8137808368185
Atlanta Gastroenterology Associates | Atlanta, Georgia, 30342, United States Recruiting Nitin Gupta, Site 0358 404-236-2333
Atlanta Gastroenterology Specialists | Suwanee, Georgia, 30024, United States Recruiting Bruce Salzberg, Site 0277
The University of Chicago Medicine | Chicago, Illinois, 60637, United States Recruiting David Rubin, Site 0319
Illinois Gastroenterology Group | Glenview, Illinois, 60026, United States Recruiting Nina Merel, Site 0346
Local Institution | Evansville, Indiana, 47714, United States Withdrawn
Indiana University Health University Hospital | Indianapolis, Indiana, 46202, United States Recruiting Monika Fischer, Site 0301 317-581-1927
University of Iowa Hospitals and Clinics | Iowa City, Iowa, 52242, United States Recruiting Steven Polyak, Site 0253 319-353-4576
Local Institution | Topeka, Kansas, 66606, United States Withdrawn
Louisiana Research Center | Shreveport, Louisiana, 71105, United States Recruiting Humberto Aguilar, Site 0282 318-423-9196
Local Institution | Chevy Chase, Maryland, 20815, United States Withdrawn
Clinical Research Institute of Michigan | Chesterfield, Michigan, 48047, United States Recruiting Ronald Fogel, Site 0003 586-598-3329
Troy Gastroenterology | Troy, Michigan, 48098, United States Recruiting John Weber, Site 0218 24826784856600
Gastroenterology Associates of Western Michigan | Wyoming, Michigan, 49519, United States Recruiting Allan Coates, Site 0047 616-328-5319
Huron Gastroenterology Associates | Ypsilanti, Michigan, 48197, United States Recruiting Najm Soofi, Site 0223
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Recruiting Sarah Glover, Site 0231
Digestive Health Center - Ocean Springs | Ocean Springs, Mississippi, 39564, United States Recruiting Alfred McNair, Site 0156 228-872-7612
Local Institution | Saint Louis, Missouri, 63130, United States Not yet recruiting Site 0359
Advanced Biomedical Research of America | Las Vegas, Nevada, 89123, United States Recruiting Vrijendra Hoon, Site 0011 702-898-2088
Local Institution | New Brunswick, New Jersey, 08901, United States Withdrawn
New York Langone Long Island Clinical Research Associates | Lake Success, New York, 11042, United States Recruiting Blanche Fung Liu, Site 0043 15164661051x330
New York-Presbyterian Columbia University Medical Center | New York, New York, 10032, United States Recruiting Bo Shen, Site 0308
Local Institution | New York, New York, 10075, United States Withdrawn
Local Institution | Chapel Hill, North Carolina, 27599-7032, United States Withdrawn
Atrium Health | Charlotte, North Carolina, 28207, United States Recruiting John Hanson, Site 0226 704-375-9485
Digestive Disease Specialists - Ambulatory Endoscopy Center - North | Oklahoma City, Oklahoma, 73112, United States Recruiting Sumit Walia, Site 0349 405-702-1246
Penn State Health Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033, United States Recruiting Kofi Clarke, Site 0238 7175310003322136
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, 15213, United States Recruiting Marc Schwartz, Site 0125
Local Institution - 0122 | Sayre, Pennsylvania, 18840, United States Completed
US Digestive Disease Associates - Wyomissing | Wyomissing, Pennsylvania, 19610, United States Recruiting Nirav Shah, Site 0357
Clinical Trials of South Carolina | Charleston, South Carolina, 29406, United States Recruiting Edward Tavel, Jr., Site 0105 843-725-5067
Local Institution | Jackson, Tennessee, 38305, United States Withdrawn
Vanderbilt Inflammatory Bowel Disease Clinic | Nashville, Tennessee, 37204, United States Recruiting David Schwartz, Site 0072
Texas Clinical Research Institute | Arlington, Texas, 76012, United States Recruiting M. Tarek Al-Assi, Site 0264 817-471-1070
Digestive Health Associates of Texas - Richardson | Garland, Texas, 75044, United States Recruiting Harry Sarles, Jr., Site 0246 972-265-8201
Local Institution | Houston, Texas, 77030, United States Withdrawn
Gastroenterology Research of San Antonio | San Antonio, Texas, 78229, United States Recruiting Nicholas Martinez, Site 0252
Southern Star Research Institute - Medical Center Office | San Antonio, Texas, 78229, United States Recruiting Jeff Bullock, Site 0307 210-271-0606
Local Institution | Southlake, Texas, 76092, United States Withdrawn
Spring Gastroenterology Associates - Houston | Spring, Texas, 77379, United States Recruiting Ravi Moparty, Site 0240
Tyler Research Institute | Tyler, Texas, 75701, United States Recruiting George DuVall, Site 0302 903-597-2314
Local Institution | Ogden, Utah, 84405, United States Withdrawn
Local Institution | Salt Lake City, Utah, 84108, United States Withdrawn
Local Institution | Lynchburg, Virginia, 24502, United States Not yet recruiting Site 0334
Hunter Holmes McGuire Veterans Administration Medical Center | Richmond, Virginia, 23249, United States Recruiting William Pandak, Site 0224
Virginia Mason Medical Center | Seattle, Washington, 98101, United States Recruiting Timothy Zisman, Site 0327
Swedish First Hill Campus | Seattle, Washington, 98104, United States Recruiting Karlee Ausk, Site 0266 206-215-4250
University of Washington | Seattle, Washington, 98195, United States Recruiting Scott Lee, Site 0191
The Vancouver Clinic | Vancouver, Washington, 98664, United States Completed
Wisconsin Center for Advanced Research, GI Associates | Milwaukee, Wisconsin, 53215, United States Recruiting Brian Moloney, Site 0356
Local Institution | Herston, Queensland, 4029, Australia Withdrawn
Mater Hospital Brisbane | South Brisbane, Queensland, 4101, Australia Recruiting Yoon-Kyo An, Site 0268
Princess Alexandra Hospital | Woolloongabba, Queensland, 4102, Australia Recruiting Gerald Holtmann, Site 0254
Local Institution - 0265 | Adelaide, South Australia, 5000, Australia Recruiting Site 0265
Ballarat Base Hospital | Ballarat, Victoria, 3350, Australia Recruiting Timothy Elliott, Site 0042 61353208517
Local Institution | Camberwell, Victoria, 3124, Australia Withdrawn
Monash Medical Centre | Clayton, Victoria, Australia Recruiting Gregory Moore, Site 0041 +610395943577
The Alfred Hospital | Melbourne, Victoria, 3004, Australia Recruiting Miles Sparrow, Site 0351
St Vincents Hospital Melbourne | Melbourne, Victoria, 3065, Australia Recruiting Nik Sheng Ding, Site 0040
Fiona Stanley Hospital | Murdoch, Western Australia, 6150, Australia Recruiting Lena Thin, Site 0275
Local Institution - 0316 | Antwerpen, 2018, Belgium Recruiting Site 0316
Universitair Ziekenhuis Antwerpen | Edegem, 2650, Belgium Recruiting Elisabeth Macken, Site 0305
Local Institution - 0322 | Gent, 9000, Belgium Recruiting Site 0322
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne | Yvoir, 5530, Belgium Recruiting Jean-Francois Rahier, Site 0314
Hospital Universitario Professor Edgard Santos | Salvador, Bahia, 40110-060, Brazil Recruiting Andre Castro Lyra, Site 0256
SER - Servicos Especializados em Reumatologia da Bahia | Salvador, Bahia, 40150150, Brazil Recruiting Mittermayer Santiago, Site 0262 +557130229886
Eurolatino Juiz de Fora Pesquisas Medicas | Juiz de Fora, Minas Gerais, 26033-318, Brazil Recruiting Juliano de Oliveira, Site 0069
Hospital das Clinicas da Faculdade de Medicina de Botucatu | Botucato, SAO Paulo, 18618-970, Brazil Recruiting Ligia Yukie Sassaki, Site 0058 +551438801684
Hospital de Clinicas de Porto Alegre | Porto Alegre, SAO Paulo, 90035-903, Brazil Recruiting Carlos Francesconi, Site 0086 +555133598307
Faculdade de Medicina do ABC | Santo Andre, SAO Paulo, 09060-650, Brazil Recruiting Wilson Roberto Catapani, Site 0059 +5511981812492
Local Institution - 0045 | Sao Bernardo do Campo, SAO Paulo, 09715-090, Brazil Recruiting Site 0045
Faculdade de Medicina de Sao Jose do Rio Preto Hospital de Base | Sao Jose do Rio Preto, SAO Paulo, 15090-000, Brazil Recruiting Geni Cunrath, Site 0085 +551732015054
Local Institution - 0017 | Rio de Janeiro, 21941-913, Brazil Recruiting Site 0017
University of Calgary | Calgary, Alberta, T2N 4N1, Canada Recruiting Remo Panaccione, Site 0048 14032206014
Dr Lim Allen Whey Khye | Edmonton, Alberta, T5R 1W2, Canada Recruiting Allen Lim, Site 0324
South Edmonton Gastroenterology Research Clinic | Edmonton, Alberta, T6K 4B2, Canada Recruiting Jesse Siffledeen, Site 0300
Vancouver Coastal Health Research Institute | Vancouver, British Columbia, V5Z1M9, Canada Recruiting James Gray, Site 0159 16048755705
Local Institution | Winnipeg, Manitoba, R3A 1R9, Canada Withdrawn
Local Institution | Etobicoke, Ontario, M9V 4B8, Canada Withdrawn
Local Institution - 0312 | London, Ontario, N6A 5A5, Canada Recruiting Site 0312
Sunnybrook Health Sciences Centre | Toronto, Ontario, M4N 3M5, Canada Recruiting Lawrence Cohen, Site 0236
Local Institution | Toronto, Ontario, M5G 1X5, Canada Withdrawn
Toronto Digestive Diseases Associates | Vaughan, Ontario, L4L 4Y7, Canada Recruiting Michael Gould, Site 0283
Local Institution | Montreal, Quebec, H3A 1A1, Canada Withdrawn
McGill University Health Centre | Montreal, Quebec, H3G 1A4, Canada Recruiting Talat Bessissow, Site 0317
Local Institution | XIamen, Fujian, 361004, China Recruiting Site 0280
Local Institution - 0225 | Guangzhou, Guangdong, 510080, China Recruiting Site 0225
Local Institution - 0228 | Guangzhou, Guangdong, 510655, China Recruiting Site 0228
Local Institution | Wuhan, Hubei, 430060, China Withdrawn
Local Institution - 0221 | Changsha, Hunan, 410011, China Recruiting Site 0221
Local Institution | Nanjing, Jiangsu, 210008, China Withdrawn
Local Institution | Nanjing, Jiangsu, 210011, China Recruiting Site 0220
Local Institution - 0306 | Nanjing, Jiangsu, 210029, China Recruiting Site 0306
Local Institution - 0250 | Changchun Shi, Jilin, 130033, China Recruiting Site 0250
Local Institution | Shenyang, Liaoning, 110022, China Recruiting Site 0299
Local Institution - 0219 | Shanghai, Shanghai, 200025, China Recruiting Site 0219
Local Institution | Shanghai, Shanghai, 200092, China Withdrawn
Local Institution | Shanghai, Shanghai, 200120, China Recruiting Site 0234
Local Institution | Hangzhou, Zhejiang, 310016, China Withdrawn
Local Institution | Osijek, 31 000, Croatia Withdrawn
Local Institution | Rijeka, 51000, Croatia Withdrawn
Local Institution | Zagreb, 10000, Croatia Withdrawn
Fakultni Nemocnice u sv. Anny v Brne | Brno, 65691, Czechia Recruiting Jan Ulbrych, Site 0337 +420543181111
Hepato-Gastroenterology HK | Hradec Kralove, 500 12, Czechia Recruiting Tomas Vanasek, Site 0057
Local Institution | Olomouc, 775 20, Czechia Withdrawn
Local Institution - 0352 | Ostrava, 702 00, Czechia Recruiting Site 0352
Fakultni Nemocnice Ostrava | Ostrava, 708 52, Czechia Recruiting Pavel Svoboda, Site 0071 +420597373232
Nemocnice Pardubickeho Kraje | Pardubice, 532 03, Czechia Recruiting Petr Vyhnalek, Site 0350
Local Institution | Plzen, 30460, Czechia Withdrawn
Local Institution | Prague 4, 140 59, Czechia Withdrawn
Klinicke centrum ISCARE IVF a.s. | Praha 9, 190 00, Czechia Active, not recruiting
Local Institution | Usti nad Orlici, 562 18, Czechia Withdrawn
Aalborg Universitetshospital | Aalborg, 9100, Denmark Recruiting Jan Fallingborg, Site 0192 +4597663567
Bispebjerg Hospital | Copenhagen NV, 2400, Denmark Recruiting Anja Poulsen, Site 0202 +4538635644
Odense University Hospital | Odense, 5000, Denmark Recruiting Jens Kjeldsen, Site 0320
Local Institution | Silkeborg, DK-8600, Denmark Withdrawn
Local Institution | Amiens Cedex 1, 80054, France Withdrawn
Hopital Beaujon | Clichy Cedex, 92110, France Recruiting Xavier Treton, Site 0110 +33140875668
Hopital Louis Mourier Colombes | Colombes, 92701, France Recruiting Benoit Coffin, Site 0168
Local Institution | Lille Cedex, 59037, France Withdrawn
Local Institution - 0343 | Montpellier cedex 5, 34295, France Recruiting Site 0343
Local Institution | Nantes, 44093, France Withdrawn
Local Institution | Nice Cedex 3, 06202, France Withdrawn
Local Institution | Paris cedex 12, 75012, France Withdrawn
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord | Saint-Etienne, 42055, France Recruiting Xavier Roblin, Site 0084 +33477828875
Hopital Rangueil | Toulouse Cedex 9, 31059, France Recruiting Cyrielle Gilletta de Saint Joseph, Site 0127 +3332044605832245
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil | Toulouse, 31300, France Recruiting Laurent Alric, Site 0167
Local Institution | Tours cedex, 37044, France Withdrawn
Charite Universitatsmedizin Berlin | Berlin, 10117, Germany Recruiting Yvonne Doerffel, Site 0099 +49030450514239
Local Institution | Berlin, 10318, Germany Withdrawn
Local Institution | Berlin, 12203, Germany Withdrawn
Charite Universitatsmedizin Berlin | Berlin, 13353, Germany Active, not recruiting
Stadtisches Klinikum Brandenburg | Brandenburg An Der Havel, 14770, Germany Recruiting Stefan Luth, Site 0339
Universitatsklinikum Frankfurt | Frankfurt am Main, 60590, Germany Recruiting Irina Blumenstein, Site 0212 +4906963014544
Local Institution | Freiburg, 79106, Germany Withdrawn
Studiengesellschaft BSF UG | Halle, 06108, Germany Recruiting Lars Fechner, Site 0178 +493414935720
Local Institution | Halle, 06120, Germany Not yet recruiting Site 0342
Local Institution | Hamburg, 22297, Germany Withdrawn
Local Institution | Hamburg, 22559, Germany Withdrawn
Medizinische Hochschule Hannover | Hannover, 30625, Germany Recruiting Christoph Schindler, Site 0294
Universitatsklinikum Jena | Jena, 07747, Germany Recruiting Andreas Stallmach, Site 0089 +4936419324582
Local Institution - 0190 | Kiel, 24105, Germany Recruiting Site 0190
Universitatsmedizin Mannheim | Mannheim, 68167, Germany Recruiting Wolfgang Reindl, Site 0321
Local Institution | Munchen, 81377, Germany Withdrawn
Gastroenterologische Gemeinschaftspraxis am Germania Campus | Munster, 48159, Germany Recruiting Axel Schweitzer, Site 0140 +4925128466825
Universitaetsklinikum Regensburg | Regensburg, D-93053, Germany Recruiting Arne Kandulski, Site 0257 +499419447029
Local Institution | Stuttgart, 70376, Germany Withdrawn
Universitatsklinikum Tubingen | Tubingen, 72076, Germany Recruiting Stefano Fusco, Site 0340
Local Institution - 0102 | Ulm, 89081, Germany Recruiting Site 0102
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz | Bekescsaba, 5600, Hungary Recruiting Marta Varga, Site 0104 +3666555582
Szent Margit Korhaz | Budapest, 1032, Hungary Withdrawn
Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary Recruiting Tibor Gyokeres, Site 0242
Semmelweis Egyetem I.sz. Belgyogyaszati Klinika | Budapest, 1083, Hungary Recruiting Akos Ilias, Site 0263 +36206663583
Local Institution - 0211 | Budapest, 1088, Hungary Recruiting Site 0211
Local Institution - 0100 | Budapest, 1097, Hungary Recruiting Site 0100
Pannonia Maganorvosi Centrum | Budapest, 1136, Hungary Recruiting Robert Schnabel, Site 0292
Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary Recruiting Istvan Ferenc Altorjay, Site 0054 +3652255842
Bugat Pal Korhaz | Gyongyos, 3200, Hungary Recruiting Gyula Horvat, Site 0083 +3637397833
Local Institution | Gyula, 5701, Hungary Withdrawn
Mohacsi Korhaz | Mohacs, 7700, Hungary Recruiting Csaba Csizmadia, Site 0210 +36302703423
Local Institution | Szeged, 6720, Hungary Withdrawn
Local Institution - 0243 | Szeged, 6725, Hungary Recruiting Site 0243
Javorszky Odon Korhaz | Vac, 2600, Hungary Recruiting Tibor Szaloki, Site 0164 +36309687716
Local Institution | Veszprem, 8200, Hungary Withdrawn
Tallaght University Hospital | Tallaght, Dublin, Ireland Recruiting Anthony OConnor, Site 0348
Portiuncula Hospital | Ballinasloe, Galway, H53 T971, Ireland Recruiting Gerard Clarke, Site 0335 +3530873317525
Our Lady of Lourdes Hospital - Drogheda | Drogheda, Louth, A92 VW28, Ireland Recruiting John Keohane, Site 0336 +3530831319980
Connolly Hospital | Dublin, D15 X40D, Ireland Recruiting Orlaith Kelly, Site 0330
Galway University Hospital | Galway, H91 YR71, Ireland Recruiting Laurence Egan, Site 0332
Local Institution | Beer Sheva, 8410101, Israel Recruiting Site 0197
Local Institution | Nahariya, 2210001, Israel Recruiting Site 0186
Local Institution | Petah Tikva, 4941492, Israel Recruiting Site 0184
Local Institution - 0198 | Rehovot, 7661041, Israel Recruiting Site 0198
Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi | Bologna, 40100, Italy Recruiting Paolo Gionchetti, Site 0290
IRCCS de Bellis | Castellana Grotte, 70013, Italy Recruiting Mauro Mastronardi, Site 0298
Local Institution - 0171 | Catanzaro, 88100, Italy Recruiting Site 0171
Local Institution | Firenza, 50134, Italy Withdrawn
Clinica Medica Azienda Ospedaliera Universitaria | Messina, 98125, Italy Recruiting Walter Fries, Site 0056
ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario | Milano, 20142, Italy Recruiting Luca Pastorelli, Site 0115
Polo Universitario - LAzienda Ospedaliera Luigi Sacco | Milano, 20157, Italy Recruiting Sandro Ardizzone, Site 0311
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano, MILANO, Italy Recruiting Flavio Caprioli, Site 0304
Azienda Ospedaliero Universitaria di Cagliari - Monserrato | Monserrato, 09042, Italy Recruiting Massimo Fantini, Site 0297
Ospedale Sacro Cuore Don Calabria | Negrar, 37024, Italy Recruiting Andrea Geccherle, Site 0310
Azienda Ospedaliera di Padova | Padova, 35128, Italy Active, not recruiting
Fondazione IRCCS Policlinico San Matteo | Pavia, 27100, Italy Recruiting Antonio Di Sabatino, Site 0170 393403500230
Local Institution | Roma, 00133, Italy Withdrawn
Local Institution | Roma, 00152, Italy Withdrawn
Local Institution - 0161 | Roma, 00168, Italy Active, not recruiting
Local Institution - 0119 | Rozzano, 20089, Italy Active, not recruiting
Ospedale Mauriziano Umberto I di Torino | Torino, 10128, Italy Recruiting Marco Daperno, Site 0285
Local Institution - 0182 | Toyoake, Aichi, 470-1192, Japan Recruiting Site 0182
Local Institution - 0199 | Hirosaki, Aomori, 036-8545, Japan Recruiting Site 0199
Toho University Sakura Medical Center | Sakura-shi, Chiba, 285-8741, Japan Recruiting Katsuyoshi Matsuoka, Site 0205 +81434628811
Ehime University Hospital | Toon, Ehime, 791-0295, Japan Recruiting Eiji Takeshita, Site 0328 +81899645111
Fukui Prefectural Hospital | Fukui-shi, Fukui, 910-8526, Japan Recruiting Kenkei Hasatani, Site 0326 +81776545151
Local Institution | Chikushino-shi, Fukuoka, 818-8502, Japan Not yet recruiting Site 0215
Fukuoka University Chikushi Hospital | Chikushino, Fukuoka, 818-8502, Japan Recruiting Akihiro Koga, Site 0204 +81929211011
Kurume University Hospital | Kurume, Fukuoka, 830-0011, Japan Recruiting Hidetoshi Takedatsu, Site 0187 +81942353311
Sapporo-Kosei General Hospital | Sapporo-Shi, Hokkaido, 060-0033, Japan Completed
Sapporo Medical University Hospital | Sapporo, Hokkaido, 060-8543, Japan Recruiting Hiroshi Nakase, Site 0323 +81116112111
Sapporo Higashi Tokushukai Hospital | Sapporo, Hokkaido, 065-0033, Japan Recruiting Atsuo Maemoto, Site 0217 +81117221110
Hyogo College of Medicine Hospital | Nishinomiya, Hyogo, 663-8501, Japan Recruiting Kenji Watanabe, Site 0183 +81798456660
Local Institution - 0207 | Sagamihara-shi, Kanagawa, 2520375, Japan Recruiting Site 0207
National Hospital Organization Sendai Medical Center | Sendai, Miyagi, 9838520, Japan Recruiting Masahiro Iwabuchi, Site 0200 +81222931111
National Hospital Organization Nagasaki Medical Center | Omura-shi, Nagasaki, 8568562, Japan Recruiting Hitoshi Nishiyama, Site 0194 +81957523121
Urasoe General Hospital | Urasoe-Shi, Okinawa, 901-2132, Japan Recruiting Fukunori Kinjo, Site 0318 +810988780231
Osaka University Hospital | Suita, Osaka, 565-0871, Japan Recruiting Shinichiro Shinzaki, Site 0179 +81668795111
Shiga University of Medical Science Hospital | Otsu, Shiga, 520-2192, Japan Recruiting Shigeki Bamba, Site 0185 +81775482111
Hamamatsu University Hospital | Hamamatsu, Shizuoka, 431-3192, Japan Recruiting Ken Sugimoto, Site 0189 +81534352111
Local Institution - 0213 | Bunkyo-ku, Tokyo, 113-8519, Japan Recruiting Site 0213
Local Institution - 0195 | Minato-ku, Tokyo, 105-8471, Japan Recruiting Site 0195
Local Institution - 0188 | Hiroshima, 734-8551, Japan Recruiting Site 0188
Local Institution - 0206 | Kyoto, 6128555, Japan Recruiting Site 0206
University of Miyazaki Hospital | Miyazaki, 8891692, Japan Recruiting Hiroshi Kawakami, Site 0214 +81985851510
Saga University Hospital | Saga, 849-8501, Japan Recruiting Motohiro Esaki, Site 0196 +81952342360
Local Institution | Ansan-si, 152-703, Korea, Republic of Recruiting Site 0158
Local Institution | Busan, 48108, Korea, Republic of Recruiting Site 0149
Local Institution | Daegu, 42415, Korea, Republic of Recruiting Site 0064
Local Institution | Daegu, 700-721, Korea, Republic of Recruiting Site 0061
Local Institution | Incheon, 22332, Korea, Republic of Recruiting Site 0150
Local Institution - 0046 | Seongnam-si, 13496, Korea, Republic of Recruiting Site 0046
Local Institution | Seoul, 03181, Korea, Republic of Recruiting Site 0015
Local Institution | Seoul, 03722, Korea, Republic of Withdrawn
Local Institution | Seoul, 137-701, Korea, Republic of Recruiting Site 0016
Local Institution - 0012 | Wonju-si, 26426, Korea, Republic of Recruiting Site 0012
Local Institution | Yangsan-si, 50612, Korea, Republic of Recruiting Site 0032
Local Institution - 0007 | Mexico, Distrito Federal, 06700, Mexico Recruiting Site 0007
Local Institution | Cuautitlan Izcalli, Estado DE Mexico, 54769, Mexico Withdrawn
Desarrollo Etico en Investigacion Clinica | Guadalajara, Jalisco, 44500, Mexico Recruiting Victoria del Carmen Padilla Rios, Site 0106 +523331232828143
JM Research - Cuernavaca | Cuernavaca, Morelos, 62290, Mexico Recruiting Jose Leon Lopez Bucio, Site 0009 +52017772633200
Cardiolink Clin Trials | Monterrey, Nuevo LEON, 64060, Mexico Recruiting Jorge Sanchez Beltran, Site 0109 +528140401554
SMIQ | Queretaro, 76070, Mexico Recruiting Claudio Marmolejo Garcia, Site 0029 +5244253754447
Local Institution | Amsterdam, 1100 DD, Netherlands Withdrawn
Amsterdam Universitair Medische Centra - Academisch Medisch Centrum | Amsterdam, 1105 AZ, Netherlands Recruiting Geert D'Haens, Site 0303
Local Institution | Groningen, 9713 GZ, Netherlands Withdrawn
Local Institution | Utrecht, 3584 CX, Netherlands Withdrawn
NZOZ Centrum Medyczne KERmed | Bydgoszcz, 85-231, Poland Recruiting Patryk Korga, Site 0245 48784655065
Local Institution - 0177 | Bydgoszcz, 85-794, Poland Recruiting Site 0177
Local Institution - 0065 | Krak, 31-501, Poland Recruiting Site 0065
Local Institution - 0284 | Lodz, 90-153, Poland Recruiting Site 0284
Centrum Medyczne Szpital Swietej Rodziny | Lodz, 90-302, Poland Recruiting Wojciech Piotrowski, Site 0098 +48512295541
Gastromed | Lublin, 20-582, Poland Recruiting Wit Danilkiewicz, Site 0291
Osrodek Badan Klinicznych Allmedica | Nowy Targ, 34-400, Poland Recruiting Mikolaj Krzyzanowski, Site 0278
ETYKA Osrodek Badan Klinicznych | Olsztyn, 10-117, Poland Active, not recruiting
Endoskopia | Sopot, 81-756, Poland Recruiting Marek Horynski, Site 0082 +48507934093
Local Institution | Szczecin, 71-685, Poland Withdrawn
H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia | Tychy, 43-100, Poland Recruiting Tomasz Romanczyk, Site 0063 +48571324508
Local Institution | Warszawa, 00-332, Poland Withdrawn
Local Institution - 0271 | Warszawa, 00-728, Poland Recruiting Site 0271
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie | Warszawa, 02-507, Poland Recruiting Grazyna Rydzewska-Wyszkowska, Site 0288
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz | Warszawa, 03-580, Poland Recruiting Robert Petryka, Site 0026 +48226792883
Wojskowy Instytut Medyczny | Warszawa, 04-141, Poland Recruiting Maciej Gonciarz, Site 0279
PlanetMed sp.z o.o. | Wroclaw, 52-210, Poland Recruiting Barbara Wozniak-Stolarska, Site 0160 +48713582444
Centrum Medyczne Oporow | Wroclaw, 52-416, Poland Recruiting Radoslaw Kempinski, Site 0034 +48717127077
Local Institution | Wroclaw, 53-114, Poland Withdrawn
Hospital da Senhora da Oliveira - Guimaraes | Guimaraes, 4835-044, Portugal Recruiting Tiago Goncalves, Site 0174 +351253540330
Centro Hospitalar de Entre o Douro e Vouga | Santa Maria da Feira, 4520-211, Portugal Recruiting Rute Cerqueira, Site 0216 +351256379700
Spitalul Universitar de Urgenta Bucuresti | Bucharest, 050098, Romania Recruiting Carmen Fierbinteanu Braticevici, Site 0074
Hyperclinica MedLife Grivita | Bucuresti, 010719, Romania Recruiting Eugeniu Craciun, Site 0067 +40756323959
Local Institution | Bucuresti, 010825, Romania Withdrawn
Spitalul Clinic Colentina | Bucuresti, 020125, Romania Recruiting Radu Bogdan Mateescu, Site 0044 0722588451
Centrul Medical Sana | Bucuresti, 031784, Romania Recruiting Nicoleta-Claudia Cimpoeru, Site 0163
Cabinet Particular Policlinic Algomed | Timisoara, 300002, Romania Recruiting Adrian Goldis, Site 0005 +400256433531
Centrul Medical Tuculanu | Timisoara, 300158, Romania Active, not recruiting
Bioterm | Barnaul, 656015, Russian Federation Active, not recruiting
Hospital Irkutsk Scientific Center | Irkutsk, 664033, Russian Federation Active, not recruiting
Local Institution | Kazan, 420012, Russian Federation Withdrawn
Republican Clinical Hospital Ministry of Health Republic of Tatarstan | Kazan, 420064, Russian Federation Active, not recruiting
Local Institution | Kemerovo, 650066, Russian Federation Withdrawn
City Clinical Hospital Number 24 | Moscow, 127015, Russian Federation Active, not recruiting
Medical Center SibNovoMed | Novosibirsk, 630005, Russian Federation Active, not recruiting
Novosibirsk Gastrocenter | Novosibirsk, 630007, Russian Federation Active, not recruiting
Novosibirsk State Regional Clinical Hospital | Novosibirsk, 630087, Russian Federation Active, not recruiting
Medical Center Healthy Family | Novosibirsk, 630099, Russian Federation Active, not recruiting
Local Institution | Novosibirsk, 630117, Russian Federation Withdrawn
Local Institution | Omsk, 644024, Russian Federation Withdrawn
Clinic Ultrasound 4D | Pyatigorsk, 357502, Russian Federation Active, not recruiting
Local Institution | Rostov-on-Don, 344022, Russian Federation Withdrawn
Local Institution | Saint-Petersburg, 191119, Russian Federation Withdrawn
Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth | Saint-Petersburg, 195257, Russian Federation Active, not recruiting
Saratov Regional Clinical Hospital | Saratov, 410038, Russian Federation Active, not recruiting
Tomsk Regional Clinical Hospital | Tomsk, 634063, Russian Federation Active, not recruiting
Multidisciplinary Consultative and Diagnostic Center | Tyumen, 625026, Russian Federation Active, not recruiting
Novgorod Regional Clinical Hospital | Velikij Novgorod, 173008, Russian Federation Active, not recruiting
Local Institution | Nitra, 949 01, Slovakia Withdrawn
Local Institution | Sahy, 93-601, Slovakia Withdrawn
Local Institution - 0329 | Alicante, 03011, Spain Recruiting Site 0329
Local Institution | Barcelona, 08022, Spain Withdrawn
Hospital Clinic de Barcelona | Barcelona, 08036, Spain Recruiting Elena Ricart Gomez, Site 0274
Local Institution - 0154 | Fuenlabrada, 28942, Spain Recruiting Site 0154
Hospital Universitari de Girona Doctor Josep Trueta | Girona, 17007, Spain Active, not recruiting
Local Institution - 0021 | Las Palmas de Gran Canaria, 35020, Spain Recruiting Site 0021
Local Institution | LHospitalet de Llobregat, 08907, Spain Not yet recruiting Site 0315
Local Institution | Manises, 46940, Spain Withdrawn
Corporacio Sanitaria Parc Tauli | Sabadell, 08208, Spain Recruiting Xavier Calvet Calvo, Site 0325
Hospital Universitario Marques de Valdecilla | Santander, 39008, Spain Recruiting Montserrat Rivero Tirado, Site 0113
Clinica Gaias-Santiago | Santiago De Compostelle, 15702, Spain Recruiting Ana Alvarez Castro, Site 0309
Hospital Universitario Virgen Macarena | Sevilla, 41009, Spain Recruiting Federico Arguelles Arias, Site 0313
Hospital Universitario Virgen del Rocio | Sevilla, 41013, Spain Recruiting Eduardo Leo Carnerero, Site 0107
Hospital Clinico Universitario de Valencia | Valencia, 46010, Spain Recruiting Miguel Minguez Perez, Site 0004
Local Institution | Lulea, 97180, Sweden Withdrawn
Local Institution | Stockholm, 182 88, Sweden Withdrawn
Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern | Bern, CH-3012, Switzerland Recruiting Frank Seibold, Site 0180 +41313023234
Local Institution | Sankt Gallen, 9007, Switzerland Withdrawn
Local Institution | Kaohsiung, 83301, Taiwan Active, not recruiting
Local Institution | Taichung, 404, Taiwan Recruiting Site 0148
Local Institution - 0267 | Taipei City, 10048, Taiwan Recruiting Site 0267
Local Institution | Taipei, 10002, Taiwan Withdrawn
Local Institution | Taoyuan, 333, Taiwan Recruiting Site 0152
Local Institution | Taoyuan, 333, Taiwan Withdrawn
Local Institution | Kharkiv, 61039, Ukraine Withdrawn
Local Institution | Kiev, 01030, Ukraine Withdrawn
Local Institution | Kiyv, 04107, Ukraine Withdrawn
Local Institution | Lviv, 79010, Ukraine Withdrawn
Local Institution | Odesa, 65117, Ukraine Withdrawn
Local Institution | Sumy, 40021, Ukraine Withdrawn
Local Institution | Vinnytsia, 21009, Ukraine Withdrawn
Local Institution | Vinnytsya, 21001, Ukraine Withdrawn
Local Institution | Zaporozhzhya, 69104, Ukraine Withdrawn
Local Institution | Belfast, BT16 1RH, United Kingdom Withdrawn
Queen Elizabeth Hospital | Birmingham, B15 2TH, United Kingdom Recruiting James Fon, Site 0289
University Hospitals Birmingham NHS Foundation Trust | Birmingham, B9 5SS, United Kingdom Recruiting Mohammed Quraishi, Site 0341
Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool, FY3 8NR, United Kingdom Active, not recruiting
Local Institution | Bury, BL9 7TD, United Kingdom Withdrawn
Cambridge University Hospitals NHS Foundation Trust | Cambridge, CB2 2QQ, United Kingdom Active, not recruiting
MAC Clinical Research - Cannock | Cannock, WS11 0BN, United Kingdom Recruiting Alexander Thompson, Site 0354
Warrington and Halton Hospitals NHS Foundation Trust | Cheshire, WA5 1QG, United Kingdom Recruiting Olomuza Doutimieriye Patani, Site 0165 +441925275513
Local Institution | Derby, DE22 3NE, United Kingdom Withdrawn
Queen Elizabeth University Hospital | Glasgow, G51 4TF, United Kingdom Active, not recruiting
Local Institution | Harrow, HA1 3UJ, United Kingdom Withdrawn
Local Institution | London, SE1 7EH, United Kingdom Withdrawn
MAC Clinical Research - Manchester | Manchester, M13 9NQ, United Kingdom Recruiting Aliya Asher, Site 0353
Abertawe Bro Morgannwg University Health Board | Swansea, SA6 6NL, United Kingdom Active, not recruiting
Location Countries

Australia

Belgium

Brazil

Canada

China

Croatia

Czechia

Denmark

France

Germany

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Poland

Portugal

Romania

Russian Federation

Slovakia

Spain

Sweden

Switzerland

Taiwan

Ukraine

United Kingdom

United States

Verification Date

2022-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: BMS-986165 Dose 1

Type: Experimental

Label: BMS-986165 Dose 2

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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