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

November 11, 2024 updated by: Celgene

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
606

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • Phone Number: please email:
  • Email: Clinical.Trials@bms.com

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150
Time Frame: Week 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission
Time Frame: Week 12
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%
Time Frame: Week 12
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
Time Frame: Week 12
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%
Time Frame: Week 12
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%
Time Frame: Week 12
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
Time Frame: Week 12
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
Time Frame: Week 12
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
Time Frame: Week 12
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%
Time Frame: Week 12
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%
Time Frame: Week 12
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
Time Frame: Week 12
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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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