Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Placebo; Drug: Ozanimod

• Study Type: Interventional
• Enrollment (Actual): 606
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Local Institution - 309
    • New Lambton Heights, New South Wales, Australia, 2305
      • Local Institution - 318
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Local Institution - 328
    • Maroorchydore, Queensland, Australia, 4558
      • Local Institution - 313
    • North Mackay, Queensland, Australia, 4740
      • Local Institution - 321
    • South Brisbane, Queensland, Australia, 4101
      • Local Institution - 312
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Local Institution - 307
    • Elizabeth Vale, South Australia, Australia, 05112
      • Local Institution - 326
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 317
    • Fitzroy, Victoria, Australia, 3065
      • Local Institution - 305
    • Geelong, Victoria, Australia, 3220
      • Local Institution - 329
    • Melbourne, Victoria, Australia, 3004
      • Local Institution - 327
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • Local Institution - 315
• Austria
  • Innsbruck, Austria, 6020
    • Local Institution - 726
  • St Polten, Austria, 3100
    • Local Institution - 727
  • Vienna, Austria, 1020
    • Local Institution - 336
  • Vienna, Austria, 1090
    • Local Institution - 725
• Bulgaria
  • Ruse, Bulgaria, 7002
    • Local Institution - 753
  • Sofia, Bulgaria, 1407
    • Local Institution - 750
  • Sofia, Bulgaria, 1407
    • Local Institution - 755
  • Sofia, Bulgaria, 1431
    • Local Institution - 756
  • Sofia, Bulgaria, 1527
    • Local Institution - 752
  • Sofia, Bulgaria, 1784
    • Local Institution - 554
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5R1W2
      • Local Institution - 269
  • British Columbia
    • New Westminister, British Columbia, Canada, V3L 3W5
      • Local Institution - 262
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Local Institution - 267
  • Manitoba
    • Brandon, Manitoba, Canada, R7A 0N7
      • Local Institution - 256
  • Ontario
    • Sudbury, Ontario, Canada, P3C 5K6
      • Local Institution - 266
    • Toronto, Ontario, Canada, M5G 1X5
      • Local Institution - 264
    • Toronto, Ontario, Canada, M5T 3A9
      • Local Institution - 257
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Local Institution - 254
    • Ottawa, Quebec, Canada, K1H 8L6
      • Local Institution - 270
• China
  • Beijing, China, 100050
    • Local Institution - 482
  • Beijing, China, 100700
    • Local Institution - 467
  • Bengbu, China, 233004
    • Local Institution - 379
  • Changchun, China, 130021
    • Local Institution - 485
  • Changchun, China, 130033
    • Local Institution - 376
  • Changsha, China, 410008
    • Local Institution - 421
  • Changsha, China, 450052
    • Local Institution - 378
  • Changzhou, China, 213004
    • Local Institution - 414
  • Chengdu, China, 610041
    • Local Institution - 419
  • Fuzhou, China, 350005
    • Local Institution - 422
  • Guangzhou, China, 510030
    • Local Institution - 478
  • Guangzhou Shi, China, 510180
    • Local Institution - 472
  • Guangzhou Shi, China, 510655
    • Local Institution - 486
  • Hangzhou, Zhejiang, China, 100142
    • Local Institution - 470
  • Hefei, China, 230001
    • Local Institution - 491
  • Kunming, China, 650032
    • Local Institution - 374
  • Luzhou, China, 646099
    • Local Institution - 383
  • Nanchang, China, 330006
    • Local Institution - 488
  • Nanjing, China, 210009
    • Local Institution - 375
  • Nanjing, China, 210029
    • Local Institution - 487
  • Nanjing City, China, 210008
    • Local Institution - 418
  • Shanghai, China, 200025
    • Local Institution - 473
  • Shanghai, China, 200040
    • Local Institution - 380
  • Shanghai, China, 200080
    • Local Institution - 377
  • Taichung City, China, 40447
    • Local Institution - 458
  • Tianjin, China, 300052
    • Local Institution - 373
  • Wuhan, China, 430022
    • Local Institution - 475
  • Wuhan, China, 430030
    • Local Institution - 474
  • Wuhan Shi, China, 430060
    • Local Institution - 483
  • Wuxi, China, 214023
    • Local Institution - 381
  • Xi'an, China, 710038
    • Local Institution - 415
  • Xi'an, China, 710100
    • Local Institution - 420
  • Zhengzhou, China, 450014
    • Local Institution - 370
  • Jiangsu
    • Changzhou City, Jiangsu, China, 213003
      • Local Institution - 423
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Local Institution - 369
• Colombia
  • Armenia, Colombia, 630004
    • Local Institution - 397
  • Barranquilla, Colombia, 080020
    • Local Institution - 398
  • Bogota, Colombia, 110221
    • Local Institution - 395
  • Cali, Colombia, 760026
    • Local Institution - 396
  • Medellin, Colombia, 050034
    • Local Institution - 394
• Finland
  • Helsinki, Finland, 00290
    • Local Institution - 613
  • Turku, Finland, FI-20521
    • Local Institution - 614
• France
  • Blois Cedex, France, 41016
    • Local Institution - 635
  • Béziers, France, 34525
    • Local Institution - 639
  • Caen, France, 14000
    • Local Institution - 634
  • Colombes, France, 92701
    • Local Institution - 644
  • Nantes, France, 44093
    • Local Institution - 632
  • Pierre-Benite, France, 69495
    • Local Institution - 630
  • Saint Priest en Jarez, France, 42270
    • Local Institution - 631
  • Cedex
    • Neuilly-sur-Seine, Cedex, France, 92200
      • Local Institution - 647
• Georgia
  • Batumi, Georgia, 6010
    • Local Institution - 786
  • Kutaisi, Georgia, 4600
    • Local Institution - 779
  • Tbilisi, Georgia, 0101
    • Local Institution - 454
  • Tbilisi, Georgia, 0112
    • Local Institution - 778
  • Tbilisi, Georgia, 0131
    • Local Institution - 782
  • Tbilisi, Georgia, 0144
    • Local Institution - 552
  • Tbilisi, Georgia, 0159
    • Local Institution - 793
  • Tbilisi, Georgia, 0160
    • Local Institution - 740
  • Tbilisi, Georgia, 0160
    • Local Institution - 783
  • Tbilisi, Georgia, 0160
    • Local Institution - 784
  • Tbilisi, Georgia, 0160
    • Local Institution - 785
  • Tbilisi, Georgia, 0179
    • Local Institution - 335
  • Tbilisi, Georgia, 0180
    • Local Institution - 455
  • Tbilisi, Georgia, 0186
    • Local Institution - 781
  • Telavi, Georgia, 2200
    • Local Institution - 780
• Germany
  • Berlin, Germany, 10787
    • Local Institution - 629
  • Berlin, Germany, 12200
    • Local Institution - 653
  • Berlin, Germany, 13353
    • Local Institution - 648
  • Berlin, Germany, 14163
    • Local Institution - 628
  • Brandenburg an der Havel, Germany, 14770
    • Local Institution - 664
  • Dachau, Germany, 85221
    • Local Institution - 732
  • Frankfurt am Main, Germany, 60313
    • Local Institution - 574
  • Frankfurt am Main, Germany, 60590
    • Local Institution - 657
  • Halle, Germany, 06108
    • Local Institution - 658
  • Halle, Germany, 06120
    • Local Institution - 656
  • Hamburg, Germany, 22559
    • Local Institution - 652
  • Hannover, Germany, 30625
    • Local Institution - 591
  • Keil, Germany, 24105
    • Local Institution - 649
  • Leipzig, Germany, 04103
    • Local Institution - 337
  • Mainz, Germany, 55131
    • Local Institution - 660
  • Muenster, Germany, 48149
    • Local Institution - 667
  • Neuruppin, Germany, 16816
    • Local Institution - 620
  • Nuertingen, Germany, 72622
    • Local Institution - 584
  • Stuttgart, Germany, 70376
    • Local Institution - 661
• Greece
  • Athens, Greece, 11 527
    • Local Institution - 790
  • Athens, Greece, 115 28
    • Local Institution - 588
  • Athens, Greece, 11527
    • Local Institution - 791
  • Athens, Greece, 18536
    • Local Institution - 792
  • Athens, Attiki, Greece, 15562
    • Local Institution - 592
  • Heraklion, Greece, 71 110
    • Local Institution - 787
  • Thessaloniki, Greece, 54642
    • Local Institution - 789
  • Thessaloniki, Greece, 56429
    • Local Institution - 788
• Hong Kong
  • Hong Kong, Hong Kong
    • Local Institution - 404
  • Kowloon, Hong Kong
    • Local Institution - 405
• Hungary
  • Bekescsaba, Hungary, 5600
    • Local Institution - 798
  • Budapest, Hungary, 1062
    • Local Institution - 803
  • Budapest, Hungary, 1088
    • Local Institution - 804
  • Budapest, Hungary, H-1036
    • Local Institution - 556
  • Gyor, Hungary, 9024
    • Local Institution - 801
  • Gyula, Hungary, 5700
    • Local Institution - 555
  • Miskolc, Hungary, 3529
    • Local Institution - 797
  • Nagykanizsa, Hungary, H-8800
    • Local Institution - 800
  • Szekesfehervar, Hungary, 8000
    • Local Institution - 799
  • Szekszárd, Hungary, 7100
    • Local Institution - 816
  • Szentes, Hungary, 6600
    • Local Institution - 805
• Israel
  • Afula, Israel, 18341
    • Local Institution - 343
  • Beer Jacob, Israel, 73100
    • Local Institution - 346
  • Haifa, Israel, 3109601
    • Local Institution - 350
  • Jerusalem, Israel, 9362410
    • Local Institution - 347
  • Kfar-Saba, Israel, 44281
    • Local Institution - 349
  • Petah Tikva, Israel, 49100
    • Local Institution - 341
  • Tel-Aviv, Israel, 64239
    • Local Institution - 340
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Local Institution - 434
  • Busan, Korea, Republic of, 612-030
    • Local Institution - 431
  • Daegu, Korea, Republic of, 705-030
    • Local Institution - 432
  • Seoul, Korea, Republic of, 3080
    • Local Institution - 438
  • Suwon, Korea, Republic of, 442723
    • Local Institution - 429
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Local Institution - 605
  • Klaipeda, Lithuania, LT-5808
    • Local Institution - 603
  • Vilnius, Lithuania, 08406
    • Local Institution - 607
  • Vilnius, Lithuania, LT-08661
    • Local Institution - 606
  • Vilnius, Lithuania, LT-10207
    • Local Institution - 604
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Local Institution - 952
  • Amsterdam, Netherlands, 1105 AZ
    • Local Institution - 955
  • Groningen, Netherlands, 9713 GZ
    • Local Institution - 956
  • Nijmegen, Netherlands, 6525 GA
    • Local Institution - 949
  • Sittard-Geleen, Netherlands, 6162 BG
    • Local Institution - 951
  • Tilburg, Netherlands, 5022 GC
    • Local Institution - 954
• Poland
  • Czestochowa, Poland, 42-202
    • Local Institution - 580
  • Elblag, Poland, 82-300
    • Local Institution - 988
  • Gdansk, Poland, 80-382
    • Local Institution - 579
  • Gdansk, Poland, 80-803
    • Local Institution - 978
  • Gdynia, Poland, 81-537
    • Local Institution - 577
  • Jelenia Gora, Poland, 58-500
    • Local Institution - 906
  • Jozefow, Poland, 05-410
    • Local Institution - 757
  • Katowice, Poland, 40-040
    • Local Institution - 578
  • Ksawerow, Poland, 95-054
    • Local Institution - 834
  • Lodz, Poland, 90-127
    • Local Institution - 581
  • Lodz, Poland, 93-034
    • Local Institution - 981
  • Nowy Targ, Poland, 34-400
    • Local Institution - 976
  • Rzeszow, Poland, 35-302
    • Local Institution - 963
  • Sopot, Poland, 81-756
    • Local Institution - 979
  • Szczecin, Poland, 71-270
    • Local Institution - 835
  • Warsaw, Poland, 00-728
    • Local Institution - 586
  • Warsaw, Poland, 02-018
    • Local Institution - 833
  • Warsaw, Poland, 04-730
    • Local Institution - 807
  • Warszawa, Poland, 02-653
    • Local Institution - 989
  • Wierzchoslawice, Poland, 33-122
    • Local Institution - 893
  • Wroclaw, Poland, 50-053
    • Local Institution - 983
  • Wroclaw, Poland, 50-367
    • Local Institution - 984
  • Wroclaw, Poland, 50-381
    • Local Institution - 582
  • Wroclaw, Poland, 51-162
    • Local Institution - 982
  • Wroclaw, Poland, 53-114
    • Local Institution - 831
  • Wroclaw, Poland, 53-333
    • Local Institution - 987
  • Wroclaw, Poland, 54-144
    • Local Institution - 832
• Portugal
  • Coimbra, Portugal, 3000-075
    • Local Institution - 959
  • Guimaraes, Portugal, 4835-044
    • Local Institution - 958
  • Loures, Portugal, 2674-514
    • Local Institution - 961
  • Viana do Castelo, Portugal, 4904-858
    • Local Institution - 957
• Russian Federation
  • Barnaul, Russian Federation, 656015
    • Local Institution - 966
  • Barnaul, Russian Federation, 656024
    • Local Institution - 871
  • Bataisk, Russian Federation, 346880
    • Local Institution - 589
  • Chelyabinsk, Russian Federation, 454021
    • Local Institution - 621
  • Chelyabinsk, Russian Federation, 454076
    • Local Institution - 991
  • Ekaterinburg, Russian Federation, 620075
    • Local Institution - 583
  • Ekaterinburg, Russian Federation, 620109
    • Local Institution - 872
  • Kaliningrad, Russian Federation, 236016
    • Local Institution - 998
  • Kaluga, Russian Federation, 248007
    • Local Institution - 882
  • Kemerovo, Russian Federation, 650066
    • Local Institution - 849
  • Moscow, Russian Federation, 105554
    • Local Institution - 566
  • Moscow, Russian Federation, 115516
    • Local Institution - 995
  • Moscow, Russian Federation, 117997
    • Local Institution - 873
  • Moscow, Russian Federation, 119192
    • Local Institution - 870
  • Moscow, Russian Federation, 123423
    • Local Institution - 869
  • Nizhny Novgorod, Russian Federation, 603140
    • Local Institution - 990
  • Novosibirsk, Russian Federation, 630091
    • Local Institution - 853
  • Novosibirsk, Russian Federation, 630117
    • Local Institution - 876
  • Omsk, Russian Federation, 644024
    • Local Institution - 996
  • Orenburg, Russian Federation, 460050
    • Local Institution - 875
  • Penza, Russian Federation, 440026
    • Local Institution - 867
  • Saint Petersburg, Russian Federation, 197110
    • Local Institution - 874
  • Saint-Petersburg, Russian Federation, 194044
    • Local Institution - 868
  • Samara, Russian Federation, 443001
    • Local Institution - 865
  • Saratov, Russian Federation, 410053
    • Local Institution - 992
  • Sochi, Russian Federation, 354207
    • Local Institution - 866
  • St Petersburg, Russian Federation, 196247
    • Local Institution - 878
  • St. Petersburg, Russian Federation, 191015
    • Local Institution - 863
  • St. Petersburg, Russian Federation, 191015
    • Local Institution - 993
  • St. Petersburg, Russian Federation, 195009
    • Local Institution - 857
  • St. Petersburg, Russian Federation, 196143
    • Local Institution - 879
  • Tomsk, Russian Federation, 634063
    • Local Institution - 877
  • Ufa, Russian Federation, 450005
    • Local Institution - 881
  • Volgograd, Russian Federation, 400107
    • Local Institution - 880
• Senegal
  • Cape Town, Senegal, 7500
    • Local Institution - 546
• Serbia
  • Belgrade, Serbia, 11 080
    • Local Institution - 887
  • Belgrade, Serbia, 11000
    • Local Institution - 596
  • Belgrade, Serbia, 11000
    • Local Institution - 886
  • Belgrade, Serbia, 11000
    • Local Institution - 890
  • Kragujevac, Serbia, 34000
    • Local Institution - 891
  • Novi Sad, Serbia, 21 000
    • Local Institution - 884
  • Pancevo, Serbia, 26000
    • Local Institution - 885
  • Vrsac, Serbia, 26300
    • Local Institution - 585
  • Zrenjanin, Serbia, 23 000
    • Local Institution - 889
• Slovakia
  • Bratislava, Slovakia, 820 07
    • Local Institution - 900
  • Bratislava, Slovakia, 82606
    • Local Institution - 894
  • Brezno, Slovakia, 97701
    • Local Institution - 895
  • Nitra, Slovakia, 94901
    • Local Institution - 899
  • Nove Zamky, Slovakia, 94002
    • Local Institution - 897
  • Presov, Slovakia, 080 01
    • Local Institution - 898
  • Rimavska Sobota, Slovakia, 979 01
    • Local Institution - 896
• Slovenia
  • Celje, Slovenia, 3000
    • Local Institution - 904
• South Africa
  • Gauteng, South Africa, 1820
    • Local Institution - 543
  • Kempton Park, South Africa, 1619
    • Local Institution - 545
  • Pretoria, South Africa, 0001
    • Local Institution - 544
  • Pretoria, South Africa, 0084
    • Local Institution - 542
  • Pretoria, South Africa, 0181
    • Local Institution - 549
  • Somerset West, South Africa, 7130
    • Local Institution - 548
  • Val De Grace, South Africa, 0184
    • Local Institution - 547
• Spain
  • Barcelona, Spain, 08022
    • Teknon Medical Center
  • Cordoba, Spain, 14001
    • University Hospital Reina Sofía
  • Girona, Spain, 17007
    • University Hospital of Girona Dr. Josep Trueta
  • Las Palmas de Gran Canaria, Spain, 35012
    • Hospital Universitario de Gran Canaria Dr. Negrin
  • Madrid, Spain, 28040
    • Local Institution - 695
  • Majadahonda, Madrid, Spain, 28222
    • University Hospital Puerta de Hierro Majadajonda
  • Santander, Spain, 39008
    • University Hospital Marques de Valdecilla (HUMV)
  • Valencia, Spain, 46010
    • Local Institution - 697
• Sweden
  • Stockholm, Sweden, 112 81
    • Local Institution - 625
• Taiwan
  • Kaohsiung, Taiwan, 82445
    • Local Institution - 460
  • Kaohsiung, San Ming Dist., Taiwan, 807
    • Local Institution - 463
  • Niao-Sung Hsiang Kaohsiung County, Taiwan, 83301
    • Local Institution - 461
  • Tainan, Taiana, Taiwan, 704
    • Local Institution - 459
  • Taoyuan City, Taiwan, 33305
    • Local Institution - 462
  • Tapei, Taiwan, 10002
    • Local Institution - 465
  • Tapei, Beitou Dist., Taiwan, 11217
    • Local Institution - 464
• Turkey
  • Ankara, Turkey, 01660
    • Local Institution - 357
  • Elazig, Turkey, 23119
    • Local Institution - 365
  • Istanbul, Turkey, 34098
    • Local Institution - 358
  • Istanbul, Turkey, 34668
    • Local Institution - 361
  • Kadiköy/Istanbul, Turkey, 41380
    • Local Institution - 353
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Local Institution - 922
  • Ivano-Frankivsk, Ukraine, 76008
    • Local Institution - 929
  • Kharkiv, Ukraine, 61037
    • Local Institution - 965
  • Khmelnytskyi, Ukraine, 29000
    • Local Institution - 920
  • Kropyvnytskyi, Ukraine, 25006
    • Local Institution - 933
  • Kyiv, Ukraine, 01601
    • Local Institution - 923
  • Kyiv, Ukraine, 02002
    • Local Institution - 563
  • Kyiv, Ukraine, 03037
    • Local Institution - 564
  • Kyiv, Ukraine, 04107
    • Local Institution - 977
  • Lutsk, Ukraine, 43005
    • Local Institution - 590
  • Lviv, Ukraine, 79010
    • Local Institution - 974
  • Odesa, Ukraine, 65025
    • Local Institution - 902
  • Vinnytsia, Ukraine, 21018
    • Local Institution - 924
  • Vinnytsya, Ukraine, 21009
    • Local Institution - 932
  • Zaporizhia, Ukraine, 69063
    • Local Institution - 587
  • Zaporizhzhya, Ukraine, 69600
    • Local Institution - 925
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Local Institution - 202
  • California
    • La Jolla, California, United States, 92037
      • UCSD Medical Center
    • Lancaster, California, United States, 93534
      • Local Institution - 010
    • Los Angeles, California, United States, 90045
      • Southern California Research Institute Medical Group, Inc.
    • Los Angeles, California, United States, 90048
      • Matrix Clinical Research Inc
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation (Parent)
    • Pasadena, California, United States, 91105
      • Local Institution - 093
    • Roseville, California, United States, 95661
      • Sutter Medical Group
    • Sacramento, California, United States, 95817
      • Local Institution - 280
    • San Francisco, California, United States, 94158
      • Local Institution - 281
    • West Covina, California, United States, 91790
      • Local Institution - 124
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Local Institution - 065
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Local Institution - 182
  • Florida
    • Clearwater, Florida, United States, 33765
      • Local Institution - 166
    • Clermont, Florida, United States, 34711
      • Local Institution - 084
    • Cutler Bay, Florida, United States, 33157
      • American Research Institute Inc
    • Doral, Florida, United States, 33166
      • Local Institution - 112
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Kissimmee, Florida, United States, 34759
      • SIH Research
    • Lighthouse Point, Florida, United States, 33064
      • Local Institution - 067
    • Maitland, Florida, United States, 32751
      • Center For Advanced Gastroenterology
    • Miami, Florida, United States, 33125
      • LMG Research
    • Miami, Florida, United States, 33166
      • Local Institution - 175
    • Miami, Florida, United States, 33176
      • Local Institution - 081
    • Miami Springs, Florida, United States, 33166
      • Local Institution - 044
    • New Port Richey, Florida, United States, 34655
      • Local Institution - 192
    • Orlando, Florida, United States, 32810
      • Local Institution - 200
    • Palmetto Bay, Florida, United States, 33157
      • Local Institution - 002
    • Pinellas Park, Florida, United States, 33781
      • Theia Clinical Research, LLC
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research, LLC.
    • Tampa, Florida, United States, 33612
      • Apex Clinical Research
    • Tampa, Florida, United States, 33612-4799
      • Local Institution - 183
    • Tampa, Florida, United States, 33614
      • Local Institution - 107
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 037
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 220
    • Decatur, Georgia, United States, 30030
      • Local Institution - 143
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Local Institution - 115
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Local Institution - 022
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Local Institution - 092
    • Indianapolis, Indiana, United States, 46202
      • Local Institution - 033
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Local Institution - 070
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Local Institution - 020
    • Lake Charles, Louisiana, United States, 70601
      • Clinical Trials of SW Louisiana LLC
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research, LLC
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Local Institution - 024
  • Michigan
    • Kalamazoo, Michigan, United States, 49008
      • Local Institution - 167
    • Novi, Michigan, United States, 48377
      • Local Institution - 005
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Local Institution - 095
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 045
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Local Institution - 198
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • Internal Medicine Specialists
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Local Institution - 040
  • New York
    • Hartsdale, New York, United States, 10530
      • Local Institution - 054
    • New York, New York, United States, 10016
      • Concorde Medical Group
    • New York, New York, United States, 10010
      • Weill Cornell Medical College
    • New York, New York, United States, 10024
      • TrialSpark
    • North Massapequa, New York, United States, 11758-1802
      • Local Institution - 060
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Local Institution - 156
    • Winston-Salem, North Carolina, United States, 27103
      • Local Institution - 052
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Local Institution - 170
    • Hilliard, Ohio, United States, 43026
      • Local Institution - 049
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research & Consulting, LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Local Institution - 087
    • Oklahoma City, Oklahoma, United States, 73102
      • Local Institution - 294
    • Tulsa, Oklahoma, United States, 74136
      • Local Institution - 185
    • Tulsa, Oklahoma, United States, 74137
      • Local Institution - 217
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Cancer Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Local Institution - 034
    • Houston, Texas, United States, 77098
      • Gulf Coast Research Group LLC
    • Houston, Texas, United States, 77058
      • Local Institution - 079
    • Houston, Texas, United States, 77089
      • Local Institution - 196
    • Pasadena, Texas, United States, 77505
      • Accurate Clinical Research Inc
    • Richardson, Texas, United States, 75082
      • Local Institution - 071
    • San Antonio, Texas, United States, 78229
      • Local Institution - 178
    • Temple, Texas, United States, 76508
      • Local Institution - 181
  • Utah
    • Riverton, Utah, United States, 84065
      • Local Institution - 292
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Local Institution - 030
    • Reston, Virginia, United States, 20191
      • The Gastroenterology Group
    • Richmond, Virginia, United States, 23249
      • Local Institution - 072
    • Roanoke, Virginia, United States, 24016
      • Local Institution - 172
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Local Institution - 089

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

• Crohn's disease for ≥ 3 months on endoscopy and on histological exam
• Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
• Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
• Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
• Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

• Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
• Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
• Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of oral Ozanimod	Drug: Ozanimod; Specified dose on specified days
Placebo Comparator: Administration of Placebo	Other: Placebo; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150	The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission	Abdominal pain and stool frequency clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 with abdominal pain and stool frequency no worse than baseline at Week 12. Participants entered the responses in diaries daily. The 7 days entries prior to Week 12 visit were considered for calculating average abdominal pain score and stool frequency. The abdominal pain was graded on severity of 0 (none) to 3 (severe) scale and stool frequency was defined number of liquid or soft stools per day. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.	Week 12
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%	The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.	Week 12
Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150	The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.	Week 12
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%	CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.	Week 12
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%	CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.	Week 12
Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points	Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.	Week 12
Percentage of Participants With Global Histologic Activity Score (GHAS) Remission	GHAS assesses the inflammation and mucosal damage. GHAS has 8 components Epithelial damage, Architectural changes, Infiltration of mononuclear cells in the lamina propria, Infiltration of polymorphonuclear cells in the lamina propria, Polymorphonuclear cells in epithelium, Presence of erosion and/or ulcers, Presence of granuloma and number of biopsy specimens affected. Each of these components was scored on a scale of 0 (none/unaffected) to 2 (worst). Each of these 8 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. Within each segment, the GHAS score has a range of 0 - 16, and the total GHAS score has a range of 0 - 80. Higher numbers correspond to more inflammation and more mucosal damage. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.	Week 12
Percentage of Participants With CDAI Reduction From Baseline of >=70 Points	The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.	Week 12
Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%	The ulcerated surface were assessed via endoscopy.	Week 12
Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%	CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. The CDEIS divides the intestine into 5 segments: rectum, sigmoid and left colon, transverse colon, right colon, and ileum. Four variables are assessed in each segment: the presence of deep ulceration, the presence of superficial ulceration, the percentage of ulcerated surface, and the percentage of surface affected by CD, indicated on 10-cm visual analogue scales. In addition, the presence of ulcerated stenosis and the presence of nonulcerated stenosis are also assessed over the entire intestine. These factors are weighted and summed to calculate the total score ranging from 0- 44, with higher scores indicating more severe disease.	Week 12
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response	AP and SF clinical remission is average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). Endoscopic Response is defined as >= 50% decrease from baseline in SES-CD. In SES-CD, each of 4 components are assessed in five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was sum of individual scores of each of components across five segments. Range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.	Week 12
Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12	RHI mucosal healing was defined as RHI remission combined with SES-CD <= 4 points and a SES-CD decrease from baseline >= 2 points with no SES-CD sub-score >1 point. RHI Remission is defined as no active inflammation in any measured segment. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation.	Week 12

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): November 21, 2023
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Crohn's Disease; Crohn Disease; Oral; Ozanimod; Moderately active; Severely active; RPC01; RPC01-3202
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Sphingosine 1 Phosphate Receptor Modulators; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Ozanimod
• Other Study ID Numbers: RPC01-3202; U1111-1203-7949 (Registry Identifier: WHO); 2017-004293-33 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No