Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

October 21, 2025 updated by: Celgene

Induction Study #1 - 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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

625

Phase

  • 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 Locations

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution - 501
      • Buenos Aires, Argentina, 1702
        • Local Institution - 571
      • Buenos Aires, Argentina, B1878
        • Local Institution - 500
      • Buenos Aires, Argentina, 1180
        • Local Institution - 494
      • Córdoba, Argentina, X5003DCE
        • Local Institution - 570
      • Córdoba, Argentina, X5016
        • Local Institution - 495
      • Mar del Plata, Argentina, B7600
        • Local Institution - 569
      • Rosario, Argentina, 2000
        • Local Institution - 496
      • Rosario, Argentina, 2000
        • Local Institution - 497
      • Rosario, Santa Fe, Argentina, S2002
        • Local Institution - 502
      • San Miguel de Tucumán, Argentina, 4000
        • Local Institution - 492
  • Australia
      • Bankstown, Australia, 2200
        • Local Institution - 325
      • Box Hill, Australia, 3128
        • Local Institution - 330
      • Sydney, NSW, Australia, NSW 2050
        • Local Institution - 324
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Local Institution - 310
      • Kingswood, New South Wales, Australia, 2747
        • Local Institution - 319
      • Wollongong, New South Wales, Australia, 2500
        • Local Institution - 323
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Local Institution - 707
      • Woolloongabba, Queensland, Australia, 4102
        • Local Institution - 311
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 308
      • Adelaide, South Australia, Australia, 5112
        • Local Institution - 708
      • Woodville South, South Australia, Australia, 5011
        • Local Institution - 320
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 709
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 316
  • Belarus
      • Grodno, Belarus, 230026
        • Local Institution - 745
      • Vitebsk, Belarus, 210604
        • Local Institution - 737
  • Belgium
      • Brussels, Belgium, 1090
        • Local Institution - 940
      • Edegem, Belgium, 2650
        • Local Institution - 939
      • Ghent, Belgium, 9000
        • Local Institution - 937
      • Leuven, Belgium, 3000
        • Local Institution - 942
      • Liège, Belgium, 4000
        • Local Institution - 936
      • Seraing, Belgium, 4100
        • Local Institution - 938
      • Tournai, Belgium, 7500
        • Local Institution - 941
    • Antwerpen
      • Brasschaat, Antwerpen, Belgium, 2930
        • Local Institution - 943
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • Local Institution - 743
      • Mostar, Bosnia and Herzegovina, 88000
        • Local Institution - 741
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Local Institution - 738
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Local Institution - 742
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Local Institution - 456
      • Plovdiv, Bulgaria, 4002
        • Local Institution - 746
      • Sofia, Bulgaria, 1202
        • Local Institution - 747
      • Sofia, Bulgaria, 1527
        • Local Institution - 627
      • Sofia, Bulgaria, 1606
        • Local Institution - 749
      • Sofia, Bulgaria, 1784
        • Local Institution - 748
      • Stara Zagora, Bulgaria, 6000
        • Local Institution - 553
      • Varna, Bulgaria, 9002
        • Local Institution - 754
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution - 273
      • Edmonton, Alberta, Canada, T5R 1W2
        • Local Institution - 227
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Local Institution - 263
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Local Institution - 255
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3CON2
        • Local Institution - 261
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • Local Institution - 268
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Local Institution - 252
      • London, Ontario, Canada, N6A 5W9
        • Local Institution - 251
      • Toronto, Ontario, Canada, M5G 1X8
        • Local Institution - 275
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Local Institution - 271
  • Chile
      • Concepción, Chile, 4070038
        • Local Institution - 389
      • Santiago, Chile, 7500010
        • Local Institution - 392
      • Santiago, Chile, 7500571
        • Local Institution - 387
      • Santiago, Chile, 7550000
        • Local Institution - 391
      • Santiago, Chile, 8320000
        • Local Institution - 390
  • Croatia
      • Koprivnica, Croatia, 48000
        • Local Institution - 453
      • Osijek, Croatia, 31000
        • Local Institution - 763
      • Rijeka, Croatia, 51000
        • Local Institution - 764
      • Split, Croatia, HR-21000
        • Local Institution - 765
      • Zagreb, Croatia, 10000
        • Local Institution - 452
      • Zagreb, Croatia, 10000
        • Local Institution - 761
      • Zagreb, Croatia, 10000
        • Local Institution - 762
      • Zagreb, Croatia, 10000
        • Local Institution - 766
  • Czechia
      • Brno, Czechia, 615 00
        • Local Institution - 767
      • Brno, Czechia, 656 91
        • Local Institution - 772
      • Hradec Králové, Czechia, 500 12
        • Local Institution - 773
      • Most, Czechia, 43401
        • Local Institution - 775
      • Olomouc, Czechia, 77900
        • Local Institution - 771
      • Pardubice, Czechia, 532 03
        • Local Institution - 774
      • Pilsen, Czechia, 30460
        • Local Institution - 769
      • Prague, Czechia, 120 00
        • Local Institution - 573
      • Prague, Czechia, 14000
        • Local Institution - 368
      • Prague, Czechia, 14021
        • Local Institution - 776
      • Prague, Czechia, 150 06
        • Local Institution - 768
      • Prague, Czechia, 190 00
        • Local Institution - 770
  • Denmark
      • Copenhagen, Denmark, 2400
        • Local Institution - 611
      • Holbæk, Denmark, 4300
        • Local Institution - 610
      • Nykøbing Falster, Denmark, 4800
        • Local Institution - 609
  • Finland
      • Turku, Finland, FI-20521
        • Local Institution - 614
  • France
      • Amiens, France, 80054
        • Local Institution - 638
      • Créteil, France, 94010
        • Local Institution - 711
      • Dijon, France, 21079
        • Local Institution - 616
      • Grenoble, France, 38700
        • Local Institution - 615
      • Lillie Cedex, France, 59037
        • Local Institution - 633
      • Marseille, France, 13915
        • Local Institution - 646
      • Montpellier, France, 34295
        • Local Institution - 507
      • Rennes, France, 35033
        • Local Institution - 641
      • Rouen, France, 76031
        • Local Institution - 612
      • Toulouse, France, 31059
        • Local Institution - 643
  • Georgia
      • Tbilisi, Georgia, 0101
        • Local Institution - 248
      • Tbilisi, Georgia, 0112
        • Local Institution - 247
      • Tbilisi, Georgia, 0180
        • Local Institution - 249
  • Germany
      • Berlin, Germany, 10117
        • Local Institution - 626
      • Berlin, Germany, 10825
        • Local Institution - 665
      • Berlin, Germany, 14050
        • Local Institution - 650
      • Frankfurt, Germany, 60431
        • Local Institution - 662
      • Frankfurt, Germany, 60594
        • Local Institution - 654
      • Hamburg, Germany, 20246
        • Local Institution - 659
      • Leipzig, Germany, 04103
        • Local Institution - 651
      • Ludwigshafen am Rhein, Germany, 67067
        • Local Institution - 655
      • Ludwigshafen am Rhein, Germany, 67067
        • Local Institution - 730
      • Stuttgart, Germany, 70376
        • Local Institution - 661
      • Tübingen, Germany, 72076
        • Local Institution - 666
      • Ulm, Germany, 89081
        • Local Institution - 663
  • India
      • Delhi, India, 110002
        • Local Institution - 457
      • New Delhi, India, 110029
        • Local Institution - 411
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500084
        • Local Institution - 444
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Local Institution - 407
    • Haryana
      • Gurgaon, Haryana, India, 122002
        • Local Institution - 332
    • Kerala
      • Kochi, Kerala, India, 682041
        • Local Institution - 445
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Local Institution - 446
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Local Institution - 443
      • Jaipur, Rajasthan, India, 302006
        • Local Institution - 399
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641044
        • Local Institution - 408
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • Local Institution - 331
  • Ireland
      • Dublin, Ireland, D09 V2N0
        • Local Institution - 973
    • Dublin
      • Dublin, Dublin, Ireland, DO4 T6F4
        • Local Institution - 975
  • Israel
      • Bat Yam, Israel, 5962025
        • Local Institution - 345
      • Jerusalem, Israel, 91031
        • Local Institution - 339
      • Nahariya, Israel, 22100
        • Local Institution - 344
      • Ramat Gan, Israel, 52621
        • Local Institution - 342
      • Rehovot, Israel, 76100
        • Local Institution - 338
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 677
      • Brescia, Italy, 25123
        • Local Institution - 684
      • Brescia, Italy, 25124
        • Local Institution - 688
      • Castellana Grotte, Italy, 70013
        • Local Institution - 689
      • Catanzaro, Italy, 88100
        • Local Institution - 679
      • Chieti, Italy, 66100
        • Local Institution - 687
      • Messina, Italy, 98125
        • Local Institution - 674
      • Milan, Italy, 20089
        • Local Institution - 672
      • Milan, Italy, 20122
        • Local Institution - 686
      • Milan, Italy, 20132
        • Local Institution - 334
      • Monza, Italy, 20900
        • Local Institution - 678
      • Padua, Italy, 35128
        • Local Institution - 685
      • Palermo, Italy, 90146
        • Local Institution - 682
      • Pavia, Italy, 27100
        • Local Institution - 673
      • Roma, Italy, 00133
        • Local Institution - 681
      • Roma, Italy, 00168
        • Local Institution - 675
      • Rome, Italy, 00152
        • Local Institution - 671
      • Udine, Italy, 33100
        • Local Institution - 680
      • Varese, Italy, 21100
        • Local Institution - 670
      • Verona, Italy, 37024
        • Local Institution - 676
  • Latvia
      • Riga, Latvia, LV-1002
        • Local Institution - 602
      • Riga, Latvia, LV-1006
        • Local Institution - 601
      • Riga, Latvia, LV-1038
        • Local Institution - 600
  • Mexico
      • Chihuahua City, Mexico, 31020
        • Local Institution - 528
      • Mexico City, Mexico, 6700
        • Local Institution - 448
      • México, Mexico, 07020
        • Local Institution - 527
      • Tlalpan, Mexico, 14080
        • Local Institution - 530
    • Jalisco
      • Zapapan, Jalisco, Mexico, 45030
        • Local Institution - 526
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64610
        • Local Institution - 532
      • Monterrey, Nuevo León, Mexico, 64718
        • Local Institution - 525
      • Monterrey, Nuevo León, Mexico, C.P 64000
        • Local Institution - 447
      • Monterrey, Nuevo León, Mexico, C.P 64060
        • Local Institution - 449
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76070
        • Local Institution - 529
  • Moldova
      • Chisinau, Moldova, MD-2068
        • Local Institution - 811
      • Chisinau, Moldova, MD2025
        • Local Institution - 809
      • Chisinau, Moldova, MD2025
        • Local Institution - 812
      • Chisinau, Moldova, MD2025
        • Local Institution - 813
      • Chisinau, Moldova, MD2005
        • Local Institution - 810
  • Poland
      • Bialystok, Poland, 15-276
        • Local Institution - 820
      • Bochnia, Poland, 32-700
        • Local Institution - 818
      • Katowice, Poland, 40-040
        • Local Institution - 238
      • Katowice, Poland, 40-660
        • Local Institution - 828
      • Katowice, Poland, 40-752
        • Local Institution - 819
      • Krakow, Poland, 30-363
        • Local Institution - 815
      • Krakow, Poland, 31-156
        • Local Institution - 823
      • Krakow, Poland, 31-501
        • Local Institution - 826
      • Kłodzko, Poland, 57-300
        • Local Institution - 817
      • Lodz, Poland, 90-302
        • Local Institution - 829
      • Lodz, Poland, 91-839
        • Local Institution - 888
      • Lublin, Poland, 20-049
        • Local Institution - 760
      • Olsztyn, Poland, 10-561
        • Local Institution - 830
      • Opole, Poland, 45-819
        • Local Institution - 402
      • Oświęcim, Poland, 32-600
        • Local Institution - 400
      • Poznan, Poland, 60-529
        • Local Institution - 758
      • Poznan, Poland, 60-702
        • Local Institution - 575
      • Poznan, Poland, 61-293
        • Local Institution - 401
      • Sopot, Poland, 81756
        • Local Institution - 239
      • Szczecin, Poland, 71434
        • Local Institution - 235
      • Torun, Poland, 87-100
        • Local Institution - 822
      • Tychy, Poland, 43-100
        • Local Institution - 824
      • Ul. Piotrkowska 177, Poland, 90-447
        • Local Institution - 827
      • Warsaw, Poland, 00-189
        • Local Institution - 410
      • Warsaw, Poland, 04-501
        • Local Institution - 236
      • Warsaw, Poland, 01-192
        • Local Institution - 576
      • Warsaw, Poland, 03-580
        • Local Institution - 825
    • Lublin Voivodeship
      • Zamość, Lublin Voivodeship, Poland, 22-400
        • Local Institution - 403
      • Zamość, Lublin Voivodeship, Poland, 22-400
        • Local Institution - 597
  • Romania
      • Bucharest, Romania, 010719
        • Local Institution - 808
      • Bucharest, Romania, 010719
        • Local Institution - 836
      • Bucharest, Romania, 013823
        • Local Institution - 499
      • Bucharest, Romania, 021494
        • Local Institution - 795
      • Bucharest, Romania, 022328
        • Local Institution - 837
      • Bucharest, Romania, 050098
        • Local Institution - 839
      • Bucharest, Romania, 10825
        • Local Institution - 842
      • Cluj-Napoca, Romania, 400001
        • Local Institution - 838
      • Craiova, Romania, 200642
        • Local Institution - 843
      • Târgu Mureş, Romania, 540136
        • Local Institution - 840
  • Russia
      • Chita, Russia, 672090
        • Local Institution - 598
      • Irkutsk, Russia, 664049
        • Local Institution - 848
      • Kazan', Russia, 420103
        • Local Institution - 892
      • Khanty-Mansiysk, Russia, 628012
        • Local Institution - 599
      • Krasnoyarsk, Russia, 660037
        • Local Institution - 927
      • Moscow, Russia, 111123
        • Local Institution - 851
      • Novosibirsk, Russia, 630007
        • Local Institution - 594
      • Petrozavodsk, Russia, 185019
        • Local Institution - 858
      • Pushkin, Russia, 196603
        • Local Institution - 859
      • Pyatigorsk, Russia, 357502
        • Local Institution - 960
      • Pyatigorsk, Russia, 357538
        • Local Institution - 846
      • Rostov-on-Don, Russia, 344022
        • Local Institution - 883
      • Saint Petersburg, Russia, 194044
        • Local Institution - 862
      • Saint Petersburg, Russia, 194354
        • Local Institution - 847
      • Saint Petersburg, Russia, 195009
        • Local Institution - 857
      • Saint Petersburg, Russia, 195067
        • Local Institution - 845
      • Saint Petersburg, Russia, 195257
        • Local Institution - 856
      • Samara, Russia, 443041
        • Local Institution - 844
      • Tula, Russia, 300053
        • Local Institution - 806
      • Ufa, Russia, 450071
        • Local Institution - 861
      • Veliky Novgorod, Russia, 173008
        • Local Institution - 855
      • Vladimir, Russia, 600023
        • Local Institution - 935
      • Vladivostok, Russia, 690091
        • Local Institution - 999
      • Vladivostok, Russia, 690922
        • Local Institution - 986
  • Saudi Arabia
      • Dammam, Saudi Arabia, 32253
        • Local Institution - 534
      • Jeddah, Saudi Arabia, 22252
        • Local Institution - 537
      • Riyadh, Saudi Arabia, 12746
        • Local Institution - 536
      • Riyadh, Saudi Arabia, 14611
        • Local Institution - 535
  • Serbia
      • Belgrade, Serbia, 11 000
        • Local Institution - 241
      • Belgrade, Serbia, 11 080
        • Local Institution - 245
      • Belgrade, Serbia, 11000
        • Local Institution - 246
  • South Korea
      • Ansan, South Korea, 152-703
        • Local Institution - 437
      • Busan, South Korea, 49201
        • Local Institution - 441
      • Guri-si, South Korea, 11923
        • Local Institution - 435
      • Seongnam-si, South Korea, 13620
        • Local Institution - 436
      • Seoul, South Korea, 06351
        • Local Institution - 433
      • Seoul, South Korea, 06591
        • Local Institution - 440
      • Seoul, South Korea, 120-752
        • Local Institution - 430
      • Seoul, South Korea, 138-736
        • Local Institution - 442
      • Seoul, South Korea, 3181
        • Local Institution - 427
      • Seoul, South Korea, 7985
        • Local Institution - 439
  • Spain
      • Alicante, Spain, 03010
        • Local Institution - 703
      • Badalona, Spain, 08916
        • Local Institution - 690
      • Madrid, Spain, 28006
        • Local Institution - 691
      • Madrid, Spain, 28046
        • Local Institution - 692
      • San Cristóbal de La Laguna, Spain, 38320
        • Local Institution - 698
      • Seville, Spain, 41009
        • Local Institution - 696
      • Seville, Spain, 41013
        • Local Institution - 705
      • Viladecans, Spain, 08840
        • Local Institution - 700
  • Switzerland
      • Bern, Switzerland, 3001
        • Local Institution - 967
      • Sankt Gallen, Switzerland, 9007
        • Local Institution - 968
      • Zurich, Switzerland, 8091
        • Local Institution - 969
  • Taiwan
      • Kozlu, Taiwan, 67000
        • Local Institution - 363
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06590
        • Local Institution - 356
      • Bursa, Turkey (Türkiye), 16059
        • Local Institution - 360
      • Istanbul, Turkey (Türkiye), 34093
        • Local Institution - 362
      • Istanbul, Turkey (Türkiye), 34840
        • Local Institution - 355
      • Izmit/Kocaeli, Turkey (Türkiye), 41380
        • Local Institution - 354
      • Trabzon, Turkey (Türkiye), 61080
        • Local Institution - 359
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Local Institution - 914
      • Dnipropetrovsk, Ukraine, 49074
        • Local Institution - 950
      • Ivano-Frankivsk, Ukraine, 76008
        • Local Institution - 229
      • Ivano-Frankivsk, Ukraine, 76018
        • Local Institution - 912
      • Kharkiv, Ukraine, 61018
        • Local Institution - 919
      • Kyiv, Ukraine, 01030
        • Local Institution - 901
      • Kyiv, Ukraine, 02000
        • Local Institution - 915
      • Kyiv, Ukraine, 02002
        • Local Institution - 243
      • Kyiv, Ukraine, 02175
        • Local Institution - 911
      • Kyiv, Ukraine, 03037
        • Local Institution - 244
      • Kyiv, Ukraine, 04053
        • Local Institution - 918
      • Kyiv, Ukraine, 04107
        • Local Institution - 908
      • Kyiv, Ukraine, 4210
        • Local Institution - 562
      • Lutsk, Ukraine, 43005
        • Local Institution - 240
      • Lviv, Ukraine, 79010
        • Local Institution - 234
      • Lviv, Ukraine, 79059
        • Local Institution - 910
      • Odesa, Ukraine, 65025
        • Local Institution - 242
      • Poltava, Ukraine, 36011
        • Local Institution - 905
      • Ternopil, Ukraine, 46008
        • Local Institution - 934
      • Vinnytsia, Ukraine, 02029
        • Local Institution - 909
      • Vinnytsia, Ukraine, 21018
        • Local Institution - 224
      • Vinnytsia, Ukraine, 21018
        • Local Institution - 971
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Local Institution - 557
      • Bristol, United Kingdom, BS2 8HW
        • Local Institution - 714
      • Cardiff, United Kingdom, CF15 9SS
        • Local Institution - 560
      • Chorley, United Kingdom, PR7 7NA
        • Local Institution - 558
      • Corbridge Road, United Kingdom, NE46 1QJ
        • Local Institution - 559
      • Dundonald, United Kingdom, BT16 1RH
        • Local Institution - 712
      • Glasgow, United Kingdom, G51 4TF
        • Local Institution - 713
      • Lancashire Blackpool, United Kingdom, FY3 8NR
        • Local Institution - 716
      • London, United Kingdom, E1 1BB
        • Local Institution - 722
      • London, United Kingdom, SE1 9RT
        • Local Institution - 715
      • North Manchester Science Park, United Kingdom, M15 6SX
        • Local Institution - 561
      • Shrewsbury, United Kingdom, SY38XQ
        • Local Institution - 593
      • Torquay, United Kingdom, TQ2 7AA
        • Local Institution - 718
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution - 723
    • LND
      • London, LND, United Kingdom, NW1 2BU
        • Local Institution - 729
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Holland Center for Family Health
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Local Institution - 026
    • California
      • Camarillo, California, United States, 93012
        • Local Institution - 284
      • Chula Vista, California, United States, 91911
        • Local Institution - 165
      • Garden Grove, California, United States, 92843
        • Local Institution - 039
      • La Mesa, California, United States, 91942
        • San Diego Clinical Trials
      • Los Angeles, California, United States, 90027
        • Local Institution - 061
      • Los Angeles, California, United States, 90067
        • Local Institution - 110
      • Mission Viejo, California, United States, 92691
        • Local Institution - 140
      • Oceanside, California, United States, 92056
        • Alliance Clinical Research
      • Orange, California, United States, 92868
        • Local Institution - 027
      • Palo Alto, California, United States, 94304
        • Palo Alto Center-Palo Alto Medical Foundation Research Institute
      • Rialto, California, United States, 92377
        • Local Institution - 006
      • San Diego, California, United States, 92123
        • Local Institution - 003
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Local Institution - 297
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Local Institution - 225
      • New Haven, Connecticut, United States, 06510
        • Local Institution - 091
    • Florida
      • Clearwater, Florida, United States, 33756-3839
        • Local Institution - 062
      • Gainesville, Florida, United States, 32608
        • Local Institution - 218
      • Hialeah, Florida, United States, 33016
        • Harmony Medical Research Institute
      • Hialeah, Florida, United States, 33010
        • Local Institution - 203
      • Hialeah, Florida, United States, 33016
        • Local Institution - 078
      • Hollywood, Florida, United States, 33021
        • Local Institution - 179
      • Homestead, Florida, United States, 33033
        • Local Institution - 101
      • Largo, Florida, United States, 33777
        • Local Institution - 016
      • Miami, Florida, United States, 33126
        • LCC Medical Research Institute, LLC
      • Miami, Florida, United States, 33125
        • Local Institution - 199
      • Miami, Florida, United States, 33156
        • Local Institution - 169
      • Naples, Florida, United States, 34109
        • Local Institution - 090
      • New Smyrna Beach, Florida, United States, 32168
        • Local Institution - 214
      • Orlando, Florida, United States, 32819
        • Local Institution - 076
      • Port Orange, Florida, United States, 32127
        • Local Institution - 098
      • Tampa, Florida, United States, 33612
        • Local Institution - 226
      • Tampa, Florida, United States, 33614
        • Local Institution - 149
      • Weeki Wachee, Florida, United States, 34607
        • Local Institution - 114
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Local Institution - 205
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 222
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 019
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 063
      • Columbus, Georgia, United States, 31904
        • Local Institution - 074
      • Macon, Georgia, United States, 31201
        • Local Institution - 028
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Local Institution - 194
      • Chicago, Illinois, United States, 60622
        • Local Institution - 036
      • Urbana, Illinois, United States, 61801
        • Local Institution - 146
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0298
        • Local Institution - 155
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • CroNola LLC
      • Lake Charles, Louisiana, United States, 70601
        • Local Institution - 053
      • New Orleans, Louisiana, United States, 70125
        • Local Institution - 104
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Local Institution - 278
      • Catonsville, Maryland, United States, 21228
        • Local Institution - 129
      • Glen Burnie, Maryland, United States, 21061
        • Local Institution - 282
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Local Institution - 142
      • North Worcester, Massachusetts, United States, 01655
        • Local Institution - 228
      • Springfield, Massachusetts, United States, 01199
        • Local Institution - 286
    • Michigan
      • Caro, Michigan, United States, 48723
        • Local Institution - 191
      • Southfield, Michigan, United States, 48034
        • Local Institution - 108
      • Wyoming, Michigan, United States, 49519
        • Local Institution - 301
      • Ypsilanti, Michigan, United States, 48197
        • Local Institution - 300
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Local Institution - 274
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 029
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Local Institution - 215
    • New York
      • Brooklyn, New York, United States, 11235
        • Local Institution - 144
      • Great Neck, New York, United States, 11021
        • Local Institution - 009
      • New York, New York, United States, 10021
        • Local Institution - 105
      • New York, New York, United States, 10075
        • Local Institution - 043
      • Orchard Park, New York, United States, 14127
        • Local Institution - 094
      • The Bronx, New York, United States, 10468
        • Advantage Clinical Trials
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Local Institution - 017
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 152
      • Charlotte, North Carolina, United States, 28207
        • Local Institution - 055
      • Greenville, North Carolina, United States, 27834
        • Local Institution - 133
      • Raleigh, North Carolina, United States, 27612
        • Local Institution - 302
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Local Institution - 210
      • Cincinnati, Ohio, United States, 45219
        • Local Institution - 291
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 018
      • Mentor, Ohio, United States, 44060
        • Local Institution - 177
      • Warren, Ohio, United States, 44483
        • Local Institution - 211
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 208
      • Oklahoma City, Oklahoma, United States, 73112
        • Local Institution - 131
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 113
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Local Institution - 197
      • State College, Pennsylvania, United States, 16803
        • Penn State University Milton S Hershey Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Local Institution - 253
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 289
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37211
        • Local Institution - 121
      • Union City, Tennessee, United States, 38261
        • Advanced Gastroenterology
    • Texas
      • Austin, Texas, United States, 78742
        • Local Institution - 158
      • Houston, Texas, United States, 77030
        • Local Institution - 056
      • Houston, Texas, United States, 77030
        • Local Institution - 150
      • Houston, Texas, United States, 77043
        • Local Institution - 102
      • Houston, Texas, United States, 77070
        • Local Institution - 082
      • Houston, Texas, United States, 77074
        • Local Institution - 303
      • Houston, Texas, United States, 77084
        • Local Institution - 088
      • San Antonio, Texas, United States, 78215
        • Local Institution - 085
      • San Antonio, Texas, United States, 78229
        • Local Institution - 223
      • Southlake, Texas, United States, 76092
        • Local Institution - 007
      • Tyler, Texas, United States, 75701
        • Local Institution - 073
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Local Institution - 025
    • Virginia
      • Gainesville, Virginia, United States, 20155
        • Local Institution - 189
      • Manassas, Virginia, United States, 20110
        • Local Institution - 298
      • Petersburg, Virginia, United States, 23805
        • Local Institution - 139
      • Suffolk, Virginia, United States, 23434
        • Virginia Gastroenterology Institute PC
      • Williamsburg, Virginia, United States, 23188
        • Local Institution - 296
    • Washington
      • Spokane, Washington, United States, 99204
        • Local Institution - 125
    • Wisconsin
      • Grafton, Wisconsin, United States, 53024
        • Aurora Health Care Aurora Research

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 therapies
  • Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
  • An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
  • Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

  • Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
  • Has 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
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
Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12
Time Frame: At Week 12
Crohn's Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn's disease. CDAI uses 8 variables: number of soft/liquid stools, severity of abdominal pain (0=none to 3=severe), general well-being (0=well to 4=terrible), presence of complications, need for antidiarrheal drugs, presence of abdominal mass, hematocrit, and change in body weight. Scores for stool number, abdominal pain, and well-being are summed over the 7 days before each visit. The other factors are also recorded and weighted to create a total CDAI score, which ranges from 0-600, with higher scores indicating worse disease (score 150-219 = mild, 220-450 = moderate, >450 = severe). This measure reports the percentage of participants whose CDAI score was below 150 at 12 weeks.
At Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants With Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12
Time Frame: At Week 12
Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as an average daily abdominal pain score ≤1 and average daily stool frequency ≤3, with AP and SF no worse than baseline at Week 12. AP was graded on a scale from 0 (none) to 3 (severe), and SF was defined as the number of liquid or soft stools per day. This measure reports the percentage of participants who, by Week 12, had low abdominal pain (score ≤1) and three or fewer bowel movements per day, without worsening symptoms compared to when they started the study. Participants began using the diary at the first visit and continued throughout the study.
At Week 12
Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12
Time Frame: At Week 12
The Simple Endoscopic Score for Crohn's Disease (SES-CD) is used to assess the degree of inflammation in patients with Crohn's disease. The SES-CD evaluates four components-size of ulcers, ulcerated surface, affected surface, and presence of narrowing-each scored from 0 (none) to 3 (severe): score ranges from 0-12 across four components and 0-60 overall across five segments (ileum, right colon, transverse colon, left colon, rectum). The total higher SES-CD score indicating greater inflammation. Baseline is defined as the last assessment prior to the first drug administration (based on the time of measurement, if available; otherwise, the last assessment prior to or on the date of first drug administration). This measure reports the percentage of participants whose SES-CD score improved by 50% or more from baseline to Week 12.
At Week 12
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12
Time Frame: At Week 12
The Crohn's Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn's disease. CDAI is calculated using 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over the 7 days prior to each visit. The remaining variables are also weighted and included in the total CDAI score, which ranges from 0-600, with higher scores indicating worse disease activity (score 150-219 = mild, 220-450 = moderate, >450 = severe). This measure reports the percentage of participants whose CDAI score improved by at least 100 points, or was below 150, at 12 weeks.
At Week 12
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12
Time Frame: At Week 12
The Crohn's Disease Activity Index (CDAI) is a composite score used to measure clinical activity in Crohn's disease. CDAI is based on 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over 7 days prior to each visit. The total CDAI score ranges from 0-600, with higher scores indicating worse disease activity (score 150-219 = mild, 220-450 = moderate, >450 = severe). This measure reports the percentage of participants whose Crohn's disease improved at 12 weeks, defined as a CDAI decrease of at least 100 points or a score below 150, along with at least a 50% reduction in intestinal inflammation (SES-CD score).
At Week 12
Percent of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12
Time Frame: At Week 12
This endpoint measured the percentage of participants who achieved both clinical remission and significant endoscopic improvement at Week 12. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than 150 at Week 12. Endoscopic improvement was defined as a decrease of at least 50% from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The CDAI was a composite score assessing disease activity based on symptoms and laboratory values, while the SES-CD evaluated endoscopic findings in the intestinal mucosa. Achieving both criteria indicated substantial improvement in both symptoms and intestinal inflammation.
At Week 12
Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12
Time Frame: At Week 12
This measure reports the percentage of participants whose Crohn's disease symptoms and gut inflammation improved at 12 weeks. It includes those with mild or no belly pain (score ≤1), no more than three bowel movements per day (score ≤3), and no worsening from baseline. It also includes participants whose gut inflammation, measured by SES-CD, was low (score ≤4) and improved by at least 2 points. SES-CD assesses inflammation based on four components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing, each scored from 0 (none) to 3 (severe) across five segments (ileum, right colon, transverse colon, left colon, rectum). The total SES-CD score ranges from 0-12 per segment and 0-60 overall, with higher scores indicating greater inflammation.
At Week 12
Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency Score no Worse Than Baseline and an SES-CD Decrease From Baseline of ≥ 50% at Week 12
Time Frame: At Week 12
This measure reports the percentage of participants whose Crohn's disease symptoms and gut inflammation improved at 12 weeks. It includes those with mild or no belly pain (score ≤1), no more than three bowel movements per day (score ≤3), and no worsening from baseline. It also includes participants whose gut inflammation, measured by SES-CD, improved by at least 50% from baseline. SES-CD assesses inflammation based on four components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing, each scored from 0 (none) to 3 (severe): score ranges from 0-12 across four components and 0-60 overall across five segments (ileum, right colon, transverse colon, left colon, rectum). The total higher SES-CD score indicating greater inflammation.
At Week 12
Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12
Time Frame: At Week 12
This measure evaluated improvement in gut inflammation at 12 wks using Global Histologic Activity Score (GHAS). GHAS was assessed for each ileal & colonic segment (ileum, right colon, transverse colon, left colon-descending/sigmoid colon & rectum). Segment subscores were calculated by adding scores for epithelial damage/tissue changes(0-2), cellular infiltration for mononuclear & polymorphonuclear cells(0-2 each), presence of certain cells(0-3) & erosion, ulcers, granulomas(0 or 1). GHAS score within each segment ranged from 0-16 & across five segments ranged from 0-80. Higher scores indicated more inflammation. Responders with histologic remission was defined as GHAS score ≤8 (each segment) [meeting criteria: epithelial damage(0), architectural changes(0-2), mononuclear cell infiltration(0-2), polymorphonuclear cell infiltration(0), polymorphonuclear cells in epithelium(0), erosion/ulcers(0), granuloma(0-1) & affected biopsy specimens(0-3)] & ≤40 (across all segments).
At Week 12
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12
Time Frame: At Week 12
This measure reports the percentage of participants whose Crohn's disease symptoms improved meaningfully after 12 weeks of treatment, defined as a decrease of at least 70 points in their Crohn's Disease Activity Index (CDAI) score from baseline. The CDAI is a composite score used to assess clinical activity in Crohn's disease, based on 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over 7 days prior to each visit. The total CDAI score ranges from 0-600, with higher scores indicating more severe disease (score 150-219 = mild, 220-450 = moderate, >450 = severe).
At Week 12
Percent of Participants With Absence of Ulcers ≥ 0.5 cm With No Segment With Any Ulcerated Surface ≥ 10% at Week 12
Time Frame: At Week 12
This measure shows the percentage of participants have no longer any large ulcers (bigger than 0.5 cm) in their gut and in any section of the gut, less than 10% of the surface has ulcers at 12 weeks. This helps to understand how well the treatment is healing the gut and reducing ulceration.
At Week 12
Percent of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% at Week 12
Time Frame: At Week 12
CDEIS is an index used to determine Crohn's disease severity by endoscopic exam of the ileum and colon. The intestine is divided into 5 segments: rectum, sigmoid/left colon, transverse colon, right colon, and ileum. In each segment, four variables are assessed: deep ulceration, superficial ulceration, percentage of ulcerated surface, and percentage of surface affected by Crohn's disease, using 10-cm visual analogue scales. The presence of ulcerated and nonulcerated stenosis is also evaluated across the entire intestine. These factors are weighted and summed for a total score from 0-44, with higher scores indicating more severe disease. This measure reports the percentage of participants whose CDEIS score improved by at least 50% at 12 weeks, based on endoscopic exam.
At Week 12

Collaborators and Investigators

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

Sponsor

Celgene

Investigators

  • 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)

February 27, 2018

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

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 (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPC01-3201
  • U1111-1203-7225 (Registry Identifier: WHO)
  • 2017-004292-31 (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.

Clinical Trials on Crohn Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe