Crohn DiseasePhase 3NCT03464097
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Ozanimod in people with Crohn Disease, run by Celgene at 765 sites in 49 countries.
Trial summary
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Ozanimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 765 sitesin 49 countries
- Study dates
- 27 Jun 2018to 3 Oct 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
- In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study
Who cannot join
- Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
- Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
765 sites in 49 countries.
765 sites in 49 countries
United States188 sites
Local Institution - 017
Asheville, North Carolina, 28801
Consultative Gastroenterology
Atlanta, Georgia, 30308
Local Institution - 037
Atlanta, Georgia, 30322
Local Institution - 220
Atlanta, Georgia, 30322
Local Institution - 222
Atlanta, Georgia, 30322
Local Institution - 019
Atlanta, Georgia, 30342
Local Institution - 063
Atlanta, Georgia, 30342
Local Institution - 158
Austin, Texas, 78742
Local Institution - 278
Baltimore, Maryland, 21224
Local Institution - 020
Baton Rouge, Louisiana, 70809
Great Lakes Medical Research, LLC
Beachwood, Ohio, 44122
Local Institution - 182
Bristol, Connecticut, 06010
Local Institution - 225
Bristol, Connecticut, 06010
Local Institution - 144
Brooklyn, New York, 11235
Local Institution - 284
Camarillo, California, 93012
Local Institution - 191
Caro, Michigan, 48723
Local Institution - 129
Catonsville, Maryland, 21228
Local Institution - 289
Charleston, South Carolina, 29425
Local Institution - 152
Charlotte, North Carolina, 28204
Local Institution - 055
Charlotte, North Carolina, 28207
Local Institution - 156
Charlotte, North Carolina, 28209
Local Institution - 142
Chestnut Hill, Massachusetts, 02467
Local Institution - 194
Chicago, Illinois, 60612
Local Institution - 036
Chicago, Illinois, 60622
Local Institution - 022
Chicago, Illinois, 60637
Sharp Chula Vista Medical Center
Chula Vista, California, 91911
Local Institution - 291
Cincinnati, Ohio, 45219
Local Institution - 062
Clearwater, Florida, 33756-3839
Clinical Research of West Florida
Clearwater, Florida, 33765
South Lake Pain Institute
Clermont, Florida, 34711
Local Institution - 018
Cleveland, Ohio, 44195
Iowa Digestive Disease Center
Clive, Iowa, 50325
Local Institution - 065
Colorado Springs, Colorado, 80907
Local Institution - 074
Columbus, Georgia, 31904
American Research Institute Inc
Cutler Bay, Florida, 33157
Local Institution - 170
Dayton, Ohio, 45417
Local Institution - 143
Decatur, Georgia, 30030
Universal Axon Clinical Research
Doral, Florida, 33166
Riverside Clinical Research
Edgewater, Florida, 32132
Local Institution - 215
Englewood, New Jersey, 07631
Local Institution - 092
Evansville, Indiana, 47714
Local Institution - 034
Fort Sam Houston, Texas, 78234
Local Institution - 218
Gainesville, Florida, 32608
Local Institution - 189
Gainesville, Virginia, 20155
Local Institution - 039
Garden Grove, California, 92843
Local Institution - 282
Glen Burnie, Maryland, 21061
Aurora Health Care Aurora Research
Grafton, Wisconsin, 53024
Local Institution - 009
Great Neck, New York, 11021
Local Institution - 133
Greenville, North Carolina, 27834
Local Institution - 054
Hartsdale, New York, 10530
Local Institution - 197
Hershey, Pennsylvania, 17033
Local Institution - 203
Hialeah, Florida, 33010
Floridian Clinical Research LLC
Hialeah, Florida, 33016
Harmony Medical Research Institute
Hialeah, Florida, 33016
Local Institution - 049
Hilliard, Ohio, 43026
Local Institution - 179
Hollywood, Florida, 33021
Vista Health Research
Homestead, Florida, 33033
CroNOLA LLC
Houma, Louisiana, 70360
Local Institution - 056
Houston, Texas, 77030
Local Institution - 150
Houston, Texas, 77030
Biopharma Informatic Inc. Research Center
Houston, Texas, 77043
Centex Studies, Inc.
Houston, Texas, 77058
GI Specialists of Houston
Houston, Texas, 77070
Local Institution - 303
Houston, Texas, 77074
Local Institution - 088
Houston, Texas, 77084
Local Institution - 196
Houston, Texas, 77089
Gulf Coast Research Group LLC
Houston, Texas, 77098
Local Institution - 115
Idaho Falls, Idaho, 83404
Local Institution - 033
Indianapolis, Indiana, 46202
Local Institution - 274
Jackson, Mississippi, 39216
Local Institution - 167
Kalamazoo, Michigan, 49008
Local Institution - 198
Kansas City, Missouri, 64111
SIH Research
Kissimmee, Florida, 34759
Local Institution - 089
La Crosse, Wisconsin, 54601
Ucsd Medical Center
La Jolla, California, 92037
San Diego Clinical Trials
La Mesa, California, 91942
Centex Studies, Inc.
Lake Charles, Louisiana, 70601
Clinical Trials of SW Louisiana LLC
Lake Charles, Louisiana, 70601
Local Institution - 297
Lakewood, Colorado, 80228
Local Institution - 010
Lancaster, California, 93534
Local Institution - 016
Largo, Florida, 33777
Internal Medicine Specialists
Las Vegas, Nevada, 89145
Local Institution - 040
Lebanon, New Hampshire, 03756
Local Institution - 155
Lexington, Kentucky, 40536-0298
Local Institution - 067
Lighthouse PT, Florida, 33064
Local Institution - 061
Los Angeles, California, 90027
Southern California Research Institute Medical Group, Inc.
Los Angeles, California, 90045
Matrix Clinical Research Inc
Los Angeles, California, 90048
Local Institution - 110
Los Angeles, California, 90067
Local Institution - 030
Lynchburg, Virginia, 24502
Local Institution - 028
Macon, Georgia, 31201
Center For Advanced Gastroenterology
Maitland, Florida, 32751
Local Institution - 298
Manassas, Virginia, 20110
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
Great Lakes Gastroenterology
Mentor, Ohio, 44060
LMG Research
Miami, Florida, 33125
Local Institution - 199
Miami, Florida, 33125
LCC Medical Research Institute, LLC
Miami, Florida, 33126
Local Institution - 169
Miami, Florida, 33156
Local Institution - 175
Miami, Florida, 33166
Vista Health Research
Miami, Florida, 33176
Local Institution - 044
Miami Springs, Florida, 33166
Local Institution - 141
Middleburg Heights, Ohio, 44130
Local Institution - 095
Minneapolis, Minnesota, 55455
Facey Medical Foundation (Parent)
Mission Hills, California, 91345
ABS Health, LLC
Mission Viejo, California, 92691
Advanced Research for Health Improvement
Naples, Florida, 34109
Local Institution - 121
Nashville, Tennessee, 37211
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Local Institution - 091
New Haven, Connecticut, 06510
Nola Research Works
New Orleans, Louisiana, 70125
Local Institution - 192
New Port Richey, Florida, 34655
Local Institution - 214
New Smyrna Beach, Florida, 32168
Weill Cornell Medical College
New York, New York, 10010
Concorde Medical Group
New York, New York, 10016
Local Institution - 105
New York, New York, 10021
TrialSpark
New York, New York, 10024
Local Institution - 043
New York, New York, 10075
Local Institution - 087
Norman, Oklahoma, 73071
Local Institution - 026
North Little Rock, Arkansas, 72117
Local Institution - 060
North Massapequa, New York, 11758-1802
Local Institution - 228
North Worcester, Massachusetts, 01655
Local Institution - 005
Novi, Michigan, 48377
Alliance Clinical Research
Oceanside, California, 92056
Local Institution - 294
Oklahoma City, Oklahoma, 73102
Local Institution - 208
Oklahoma City, Oklahoma, 73104
Local Institution - 131
Oklahoma City, Oklahoma, 73112
Local Institution - 027
Orange, California, 92868
Circuit Clinical
Orchard Park, New York, 14127
Local Institution - 200
Orlando, Florida, 32810
Local Institution - 076
Orlando, Florida, 32819
Local Institution - 002
Palmetto Bay, Florida, 33157
Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94304
Havana Research Institute LLC
Pasadena, California, 91105
Accurate Clinical Research Inc
Pasadena, Texas, 77505
Holland Center for Family Health
Peoria, Arizona, 85381
Summit Clinical Research, LLC
Petersburg, Virginia, 23805
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Theia Clinical Research, LLC
Pinellas Park, Florida, 33781
Local Institution - 098
Port Orange, Florida, 32127
Local Institution - 113
Portland, Oregon, 97239
Local Institution - 253
Providence, Rhode Island, 02904
Local Institution - 302
Raleigh, North Carolina, 27612
The Gastroenterology Group
Reston, Virginia, 20191
Local Institution - 006
Rialto, California, 92377
Local Institution - 071
Richardson, Texas, 75082
Local Institution - 072
Richmond, Virginia, 23249
Local Institution - 292
Riverton, Utah, 84065
Local Institution - 172
Roanoke, Virginia, 24016
Local Institution - 045
Rochester, Minnesota, 55905
Sutter Medical Group
Roseville, California, 95661
Local Institution - 280
Sacramento, California, 95817
Local Institution - 025
Salt Lake City, Utah, 84132
Local Institution - 085
San Antonio, Texas, 78215
Local Institution - 223
San Antonio, Texas, 78229-4894
Local Institution - 178
San Antonio, Texas, 78229
Local Institution - 003
San Diego, California, 92123
Local Institution - 281
San Francisco, California, 94158
Local Institution - 202
Scottsdale, Arizona, 85258
Local Institution - 108
Southfield, Michigan, 48034
Local Institution - 007
Southlake, Texas, 76092
Local Institution - 125
Spokane, Washington, 99204
Local Institution - 286
Springfield, Massachusetts, 01199
Local Institution - 029
St Louis, Missouri, 63110
Penn State University Milton S Hershey Medical Center
State College, Pennsylvania, 16803
Virginia Gastroenterology Institute PC
Suffolk, Virginia, 23434
Precision Clinical Research, LLC.
Sunrise, Florida, 33351
Local Institution - 183
Tampa, Florida, 33612-4799
Apex Clinical Research
Tampa, Florida, 33612
Local Institution - 226
Tampa, Florida, 33612
Local Institution - 107
Tampa, Florida, 33614
Local Institution - 149
Tampa, Florida, 33614
Local Institution - 181
Temple, Texas, 76508
Advantage Clinical Trials
The Bronx, New York, 10468
Local Institution - 070
Topeka, Kansas, 66606
Local Institution - 185
Tulsa, Oklahoma, 74136
Local Institution - 217
Tulsa, Oklahoma, 74137
Local Institution - 073
Tyler, Texas, 75701
Advanced Gastroenterology
Union City, Tennessee, 38261
Carle Foundation Hospital
Urbana, Illinois, 61801
Great Lakes Medical Research, LLC
Warren, Ohio, 44483
Local Institution - 114
Weeki Wachee, Florida, 34607
New Hope Research Development
West Covina, California, 91790
Local Institution - 296
Williamsburg, Virginia, 23188
Local Institution - 052
Winston-Salem, North Carolina, 27103
Local Institution - 024
Worcester, Massachusetts, 01655
Local Institution - 301
Wyoming, Michigan, 49519
Local Institution - 300
Ypsilanti, Michigan, 48197
Poland55 sites
Local Institution - 820
Bialystok, 15-276
Local Institution - 818
Bochnia, 32-700
Local Institution - 580
Częstochowa, 42-202
Local Institution - 988
Elblag, 82-300
Local Institution - 579
Gdansk, 80-382
Local Institution - 978
Gdansk, 80-803
Local Institution - 577
Gdynia, 81-537
Local Institution - 906
Jelenia Góra, 58-500
Local Institution - 757
Józefów, 05-410
Local Institution - 238
Katowice, 40-040
Local Institution - 578
Katowice, 40-040
Local Institution - 828
Katowice, 40-660
Local Institution - 819
Katowice, 40-752
Local Institution - 817
Kłodzko, 57-300
Local Institution - 815
Krakow, 30-363
Local Institution - 823
Krakow, 31-156
Local Institution - 826
Krakow, 31-501
Local Institution - 834
Ksawerów, 95-054
Local Institution - 581
Lodz, 90-127
Local Institution - 829
Lodz, 90-302
Local Institution - 888
Lodz, 91-839
Local Institution - 981
Lodz, 93-034
Local Institution - 760
Lublin, 20-049
Local Institution - 976
Nowy Targ, 34-400
Local Institution - 830
Olsztyn, 10-561
Local Institution - 402
Opole, 45-819
Local Institution - 400
Oświęcim, 32-600
Local Institution - 758
Poznan, 60-529
Local Institution - 575
Poznan, 60-702
Local Institution - 401
Poznan, 61-293
Local Institution - 963
Rzeszów, 35-302
Local Institution - 979
Sopot, 81-756
Local Institution - 239
Sopot, 81756
Local Institution - 835
Szczecin, 71-270
Local Institution - 235
Szczecin, 71434
Local Institution - 822
Torun, 87-100
Local Institution - 824
Tychy, 43-100
Local Institution - 827
Ul. Piotrkowska 177, 90-447
Local Institution - 410
Warsaw, 00-189
Local Institution - 576
Warsaw, 01-192
Local Institution - 833
Warsaw, 02-018
Local Institution - 989
Warsaw, 02-653
Local Institution - 236
Warsaw, 04-501
Local Institution - 586
Warsaw, 04-501
Local Institution - 807
Warsaw, 04-730
Local Institution - 893
Wierzchosławice, 33-122
Local Institution - 983
Wroclaw, 50-053
Local Institution - 984
Wroclaw, 50-367
Local Institution - 582
Wroclaw, 50-381
Local Institution - 982
Wroclaw, 51-162
Local Institution - 831
Wroclaw, 53-114
Local Institution - 987
Wroclaw, 53-333
Local Institution - 832
Wroclaw, 54-144
Local Institution - 403
Zamość, Lublin Voivodeship, 22-400
Local Institution - 597
Zamość, Lublin Voivodeship, 22-400
Russia53 sites
Local Institution - 871
Barnaul, 656024
Local Institution - 589
Bataysk, 346880
Local Institution - 621
Chelyabinsk, 454021
Local Institution - 991
Chelyabinsk, 454076
Local Institution - 598
Chita, 672090
Local Institution - 848
Irkutsk, 664049
Local Institution - 998
Kaliningrad, 236016
Local Institution - 882
Kaluga, 248007
Local Institution - 892
Kazan', 420103
Local Institution - 849
Kemerovo, 650066
Local Institution - 599
Khanty-Mansiysk, 628012
Local Institution - 927
Krasnoyarsk, 660037
Local Institution - 566
Moscow, 105554
Local Institution - 851
Moscow, 111123
Local Institution - 873
Moscow, 117997
Local Institution - 870
Moscow, 119192
Local Institution - 869
Moscow, 123423
Local Institution - 990
Nizhny Novgorod, 603140
Local Institution - 594
Novosibirsk, 630007
Local Institution - 853
Novosibirsk, 630091
Local Institution - 876
Novosibirsk, 630117
Local Institution - 996
Omsk, 644024
Local Institution - 875
Orenburg, 460050
Local Institution - 867
Penza, 440026
Local Institution - 858
Petrozavodsk, 185019
Local Institution - 859
Pushkin, 196603
Local Institution - 960
Pyatigorsk, 357502
Local Institution - 846
Pyatigorsk, 357538
Local Institution - 863
Saint Petersburg, 191015
Local Institution - 993
Saint Petersburg, 191015
Local Institution - 862
Saint Petersburg, 194044
Local Institution - 868
Saint Petersburg, 194044
Local Institution - 847
Saint Petersburg, 194354
Local Institution - 857
Saint Petersburg, 195009
Local Institution - 845
Saint Petersburg, 195067
Local Institution - 856
Saint Petersburg, 195257
Local Institution - 879
Saint Petersburg, 196143
Local Institution - 878
Saint Petersburg, 196247
Local Institution - 874
Saint Petersburg, 197110
Local Institution - 865
Samara, 443001
Local Institution - 844
Samara, 443041
Local Institution - 866
Sochi, 354207
Local Institution - 877
Tomsk, 634063
Local Institution - 806
Tula, 300053
Local Institution - 881
Ufa, 450005
Local Institution - 861
Ufa, 450071
Local Institution - 855
Velikiy Novgorod, 173008
Local Institution - 935
Vladimir, 600023
Local Institution - 999
Vladivostok, 690091
Local Institution - 986
Vladivostok, 690922
Local Institution - 880
Volgograd, 400107
Local Institution - 583
Yekaterinburg, 620075
Local Institution - 872
Yekaterinburg, 620109
Ukraine38 sites
Local Institution - 914
Chernivtsi, 58001
Local Institution - 922
Chernivtsi, 58001
Local Institution - 950
Dnipropetrovsk, 49074
Local Institution - 229
Ivano-Frankivsk, 76008
Local Institution - 929
Ivano-Frankivsk, 76008
Local Institution - 912
Ivano-Frankivsk, 76018
Local Institution - 919
Kharkiv, 61018
Local Institution - 965
Kharkiv, 61037
Local Institution - 920
Khmelnytskyi, 29000
Local Institution - 933
Kropyvnytskyi, 25006
Local Institution - 901
Kyiv, 01030
Local Institution - 923
Kyiv, 01601
Local Institution - 915
Kyiv, 02000
Local Institution - 243
Kyiv, 02002
Local Institution - 563
Kyiv, 02002
Local Institution - 911
Kyiv, 02175
Local Institution - 244
Kyiv, 03037
Local Institution - 564
Kyiv, 03037
Local Institution - 918
Kyiv, 04053
Local Institution - 908
Kyiv, 04107
Local Institution - 977
Kyiv, 04107
Local Institution - 562
Kyiv, 4210
Local Institution - 240
Lutsk, 43005
Local Institution - 590
Lutsk, 43005
Local Institution - 234
Lviv, 79010
Local Institution - 974
Lviv, 79010
Local Institution - 910
Lviv, 79059
Local Institution - 242
Odesa, 65025
Local Institution - 902
Odesa, 65025
Local Institution - 905
Poltava, 36011
Local Institution - 934
Ternopil, 46008
Local Institution - 909
Vinnytsia, 02029
Local Institution - 932
Vinnytsia, 21009
Local Institution - 224
Vinnytsia, 21018
Local Institution - 924
Vinnytsia, 21018
Local Institution - 971
Vinnytsia, 21018
Local Institution - 587
Zaporizhia, 69063
Local Institution - 925
Zaporizhzhya, 69600
China36 sites
Local Institution - 482
Beijing, 100050
Local Institution - 467
Beijing, 100700
Local Institution - 379
Bengbu, 233004
Local Institution - 485
Changchun, 130021
Local Institution - 376
Changchun, 130033
Local Institution - 421
Changsha, 410008
Local Institution - 378
Changsha, 450052
Local Institution - 423
Changzhou, Jiangsu, 213003
Local Institution - 414
Changzhou, 213004
Local Institution - 419
Chengdu, Sichuan, 610041
Local Institution - 422
Fuzhou, 350005
Local Institution - 478
Guangzhou, 510030
Local Institution - 472
Guangzhou, 510180
Local Institution - 486
Guangzhou, 510655
Local Institution - 470
Hangzhou, Zhejiang, 100142
Local Institution - 491
Hefei, 230001
Local Institution - 374
Kunming, 650032
Local Institution - 383
Luzhou, 646099
Local Institution - 488
Nanchang, 330006
Local Institution - 418
Nanjing, 210008
Local Institution - 375
Nanjing, 210009
Local Institution - 487
Nanjing, 210029
Local Institution - 369
Shanghai, Shanghai Municipality, 200120
Local Institution - 473
Shanghai, 200025
Local Institution - 380
Shanghai, 200040
Local Institution - 377
Shanghai, 200080
Local Institution - 416
Shanghai, 200092
Local Institution - 458
Taichung City, 40447
Local Institution - 373
Tianjin, 300052
Local Institution - 475
Wuhan, 430022
Local Institution - 474
Wuhan, 430030
Local Institution - 483
Wuhan, 430060
Local Institution - 381
Wuxi, 214023
Local Institution - 415
Xi'an, 710038
Local Institution - 420
Xi'an, 710100
Local Institution - 370
Zhengzhou, 450014
Germany30 sites
Local Institution - 626
Berlin, 10117
Local Institution - 629
Berlin, 10787
Local Institution - 665
Berlin, 10825
Local Institution - 653
Berlin, 12200
Local Institution - 648
Berlin, 13353
Local Institution - 650
Berlin, 14050
Local Institution - 628
Berlin, 14163
Local Institution - 664
Brandenburg an der Havel, 14770
Local Institution - 732
Dachau, 85221
Local Institution - 662
Frankfurt, 60431
Local Institution - 654
Frankfurt, 60594
Local Institution - 574
Frankfurt am Main, 60313
Local Institution - 657
Frankfurt am Main, 60590
Local Institution - 658
Halle, 06108
Local Institution - 656
Halle, 06120
Local Institution - 659
Hamburg, 20246
Local Institution - 652
Hamburg, 22559
Local Institution - 591
Hanover, 30625
Local Institution - 649
Keil, 24105
Local Institution - 337
Leipzig, 04103
Local Institution - 651
Leipzig, 04103
Local Institution - 655
Ludwigshafen am Rhein, 67067
Local Institution - 730
Ludwigshafen am Rhein, 67067
Local Institution - 660
Mainz, 55131
Local Institution - 667
Münster, 48149
Local Institution - 620
Neuruppin, 16816
Local Institution - 584
Nürtingen, 72622
Local Institution - 661
Stuttgart, 70376
Local Institution - 666
Tübingen, 72076
Local Institution - 663
Ulm, 89081
Australia26 sites
Local Institution - 308
Adelaide, South Australia, 5000
Local Institution - 708
Adelaide, South Australia, 5112
Local Institution - 325
Bankstown, 2200
Local Institution - 307
Bedford Park, South Australia, 5042
Local Institution - 330
Box Hill, 3128
Local Institution - 317
Clayton, Victoria, 3168
Local Institution - 310
Concord, New South Wales, 2139
Local Institution - 326
Elizabeth Vale, South Australia, 05112
Local Institution - 305
Fitzroy, Victoria, 3065
Local Institution - 329
Geelong, Victoria, 3220
Local Institution - 328
Herston, Queensland, 4029
Local Institution - 319
Kingswood, New South Wales, 2747
Local Institution - 309
Liverpool, New South Wales, 2170
Local Institution - 707
Maroochydore, Queensland, 4558
Local Institution - 313
Maroorchydore, Queensland, 4558
Local Institution - 327
Melbourne, Victoria, 3004
Local Institution - 709
Melbourne, Victoria, 3004
Local Institution - 316
Murdoch, Western Australia, 6150
Local Institution - 318
New Lambton Heights, New South Wales, 2305
Local Institution - 321
North Mackay, Queensland, 4740
Local Institution - 312
South Brisbane, Queensland, 4101
Local Institution - 315
Subiaco, Western Australia, 6008
Local Institution - 324
Sydney, NSW, NSW 2050
Local Institution - 323
Wollongong, New South Wales, 2500
Local Institution - 320
Woodville South, South Australia, 5011
Local Institution - 311
Woolloongabba, Queensland, 4102
Italy20 sites
Local Institution - 677
Bologna, 40138
Local Institution - 684
Brescia, 25123
Local Institution - 688
Brescia, 25124
Local Institution - 689
Castellana Grotte, 70013
Local Institution - 679
Catanzaro, 88100
Local Institution - 687
Chieti, 66100
Local Institution - 674
Messina, 98125
Local Institution - 672
Milan, 20089
Local Institution - 686
Milan, 20122
Local Institution - 334
Milan, 20132
Local Institution - 678
Monza, 20900
Local Institution - 685
Padova, 35128
Local Institution - 682
Palermo, 90146
Local Institution - 673
Pavia, 27100
Local Institution - 681
Roma, 00133
Local Institution - 675
Roma, 00168
Local Institution - 671
Rome, 00152
Local Institution - 680
Udine, 33100
Local Institution - 670
Varese, 21100
Local Institution - 676
Verona, 37024
Canada18 sites
Local Institution - 256
Brandon, Manitoba, R7A 0N7
Local Institution - 268
Bridgewater, Nova Scotia, B4V 3N2
Local Institution - 273
Calgary, Alberta, T2N 4Z6
Local Institution - 227
Edmonton, Alberta, T5R 1W2
Local Institution - 269
Edmonton, Alberta, T5R1W2
Local Institution - 266
Greater Sudbury, Ontario, P3C 5K6
Local Institution - 263
Kelowna, British Columbia, V1Y 1Z9
Local Institution - 252
London, Ontario, N6A 5A5
Local Institution - 251
London, Ontario, N6A 5W9
Local Institution - 254
Montreal, Quebec, H1T 2M4
Local Institution - 262
New Westminster, British Columbia, V3L 3W5
Local Institution - 270
Ottawa, Quebec, K1H 8L6
Local Institution - 264
Toronto, Ontario, M5G 1X5
Local Institution - 257
Toronto, Ontario, M5T 3A9
Local Institution - 255
Vancouver, British Columbia, V5Z1M9
Local Institution - 267
Vancouver, British Columbia, V6Z 2K5
Local Institution - 271
Vaughan, Ontario, L4L 4Y7
Local Institution - 261
Winnipeg, Manitoba, R3CON2
France18 sites
Local Institution - 638
Amiens, 80054
Local Institution - 639
Béziers, 34525
Local Institution - 635
Blois, 41016
Local Institution - 634
Caen, 14000
Local Institution - 644
Colombes, 92701
Local Institution - 711
Créteil, 94010
Local Institution - 616
Dijon, 21079
Local Institution - 615
Grenoble, 38700
Local Institution - 633
Lillie Cedex, 59037
Local Institution - 646
Marseille, 13915
Local Institution - 507
Montpellier, 34295
Local Institution - 632
Nantes, 44093
Local Institution - 647
Neuilly-sur-Seine, Cedex, 92200
Local Institution - 630
Pierre-Bénite, 69495
Local Institution - 641
Rennes, 35033
Local Institution - 612
Rouen, 76031
Local Institution - 631
Saint-Priest-en-Jarez, 42270
Local Institution - 643
Toulouse, 31059
Georgia18 sites
Local Institution - 786
Batumi, 6010
Local Institution - 779
Kutaisi, 4600
Local Institution - 248
Tbilisi, 0101
Local Institution - 454
Tbilisi, 0101
Local Institution - 783
Tbilisi, 0101
Local Institution - 247
Tbilisi, 0112
Local Institution - 778
Tbilisi, 0112
Local Institution - 782
Tbilisi, 0131
Local Institution - 552
Tbilisi, 0144
Local Institution - 781
Tbilisi, 0159
Local Institution - 793
Tbilisi, 0159
Local Institution - 740
Tbilisi, 0160
Local Institution - 784
Tbilisi, 0160
Local Institution - 785
Tbilisi, 0160
Local Institution - 335
Tbilisi, 0179
Local Institution - 249
Tbilisi, 0180
Local Institution - 455
Tbilisi, 0180
Local Institution - 780
Telavi, 2200
Spain16 sites
Local Institution - 703
Alicante, 03010
Local Institution - 690
Badalona, 08916
Local Institution - 694
Barcelona, 08022
Local Institution - 702
Córdoba, 14001
Local Institution - 699
Girona, 17007
Local Institution - 701
Las Palmas de Gran Canaria, 35012
Local Institution - 691
Madrid, 28006
Local Institution - 695
Madrid, 28040
Local Institution - 692
Madrid, 28046
Local Institution - 693
Majadahonda, Madrid, 28222
Local Institution - 698
San Cristóbal de La Laguna, 38320
Local Institution - 706
Santander, 39008
Local Institution - 696
Seville, 41009
Local Institution - 705
Seville, 41013
Local Institution - 697
Valencia, 46010
Local Institution - 700
Viladecans, 08840
South Korea15 sites
Local Institution - 437
Ansan, 152-703
Local Institution - 441
Busan, 49201
Local Institution - 434
Busan, 49241
Local Institution - 431
Busan, 612-030
Local Institution - 432
Daegu, 705-030
Local Institution - 435
Guri-si, 11923
Local Institution - 436
Seongnam-si, 13620
Local Institution - 433
Seoul, 06351
Local Institution - 440
Seoul, 06591
Local Institution - 430
Seoul, 120-752
Local Institution - 442
Seoul, 138-736
Local Institution - 438
Seoul, 3080
Local Institution - 427
Seoul, 3181
Local Institution - 439
Seoul, 7985
Local Institution - 429
Suwon, 442723
United Kingdom15 sites
Local Institution - 557
Birmingham, B15 2SQ
Local Institution - 714
Bristol, BS2 8HW
Local Institution - 560
Cardiff, CF15 9SS
Local Institution - 558
Chorley, PR7 7NA
Local Institution - 559
Corbridge Road, NE46 1QJ
Local Institution - 712
Dundonald, BT16 1RH
Local Institution - 713
Glasgow, G51 4TF
Local Institution - 716
Lancashire Blackpool, FY3 8NR
Local Institution - 729
London, LND, NW1 2BU
Local Institution - 722
London, E1 1BB
Local Institution - 715
London, SE1 9RT
Local Institution - 561
North Manchester Science Park, M15 6SX
Local Institution - 593
Shrewsbury, SY38XQ
Local Institution - 723
Southampton, Hampshire, SO16 6YD
Local Institution - 718
Torquay, TQ2 7AA
Bulgaria14 sites
Local Institution - 456
Blagoevgrad, 2700
Local Institution - 746
Plovdiv, 4002
Local Institution - 753
Rousse, 7002
Local Institution - 747
Sofia, 1202
Local Institution - 750
Sofia, 1407
Local Institution - 755
Sofia, 1407
Local Institution - 756
Sofia, 1431
Local Institution - 627
Sofia, 1527
Local Institution - 752
Sofia, 1527
Local Institution - 749
Sofia, 1606
Local Institution - 554
Sofia, 1784
Local Institution - 748
Sofia, 1784
Local Institution - 553
Stara Zagora, 6000
Local Institution - 754
Varna, 9002
Czechia12 sites
Local Institution - 767
Brno, 615 00
Local Institution - 772
Brno, 656 91
Local Institution - 773
Hradec Králové, 500 12
Local Institution - 775
Most, 43401
Local Institution - 771
Olomouc, 77900
Local Institution - 774
Pardubice, 532 03
Local Institution - 769
Pilsen, 30460
Local Institution - 573
Prague, 120 00
Local Institution - 368
Prague, 14000
Local Institution - 776
Prague, 14021
Local Institution - 768
Prague, 150 06
Local Institution - 770
Prague, 190 00
Israel12 sites
Local Institution - 343
Afula, 18341
Local Institution - 345
Bat Yam, 5962025
Local Institution - 346
Beer Jacob, 73100
Local Institution - 350
Haifa, 3109601
Local Institution - 339
Jerusalem, 91031
Local Institution - 347
Jerusalem, 9362410
Local Institution - 349
Kfar Saba, 44281
Local Institution - 344
Nahariya, 22100
Local Institution - 341
Petah Tikva, 49100
Local Institution - 342
Ramat Gan, 52621
Local Institution - 338
Rehovot, 76100
Local Institution - 340
Tel Aviv, 64239
Serbia12 sites
Local Institution - 241
Belgrade, 11 000
Local Institution - 245
Belgrade, 11 080
Local Institution - 887
Belgrade, 11 080
Local Institution - 246
Belgrade, 11000
Local Institution - 596
Belgrade, 11000
Local Institution - 886
Belgrade, 11000
Local Institution - 890
Belgrade, 11000
Local Institution - 891
Kragujevac, 34000
Local Institution - 884
Novi Sad, 21 000
Local Institution - 885
Pančevo, 26000
Local Institution - 585
Vršac, 26300
Local Institution - 889
Zrenjanin, 23 000
Argentina11 sites
Local Institution - 501
Buenos Aires, 0
Local Institution - 494
Buenos Aires, 1180
Local Institution - 571
Buenos Aires, 1702
Local Institution - 500
Buenos Aires, B1878
Local Institution - 570
Córdoba, X5003DCE
Local Institution - 495
Córdoba, X5016
Local Institution - 569
Mar del Plata, B7600
Local Institution - 496
Rosario, 2000
Local Institution - 497
Rosario, 2000
Local Institution - 502
Rosario, Santa Fe, S2002
Local Institution - 492
San Miguel de Tucumán, 4000
Hungary11 sites
Local Institution - 798
Békéscsaba, 5600
Local Institution - 803
Budapest, 1062
Local Institution - 804
Budapest, 1088
Local Institution - 556
Budapest, H-1036
Local Institution - 801
Győr, 9024
Local Institution - 555
Gyula, 5700
Local Institution - 797
Miskolc, 3529
Local Institution - 800
Nagykanizsa, H-8800
Local Institution - 799
Székesfehérvár, 8000
Local Institution - 816
Szekszárd, 7100
Local Institution - 805
Szentes, 6600
India11 sites
Local Institution - 408
Coimbatore, Tamil Nadu, 641044
Local Institution - 457
Delhi, 110002
Local Institution - 332
Gurgaon, Haryana, 122002
Local Institution - 444
Hyderabad, Andhra Pradesh, 500084
Local Institution - 331
Hyderabad, Telangana, 500032
Local Institution - 443
Jaipur, Rajasthan, 302004
Local Institution - 399
Jaipur, Rajasthan, 302006
Local Institution - 445
Kochi, Kerala, 682041
Local Institution - 446
Ludhiana, Punjab, 141001
Local Institution - 411
New Delhi, 110029
Local Institution - 407
Surat, Gujarat, 395002
Turkey (Türkiye)11 sites
Local Institution - 357
Ankara, 01660
Local Institution - 356
Ankara, 06590
Local Institution - 360
Bursa, 16059
Local Institution - 365
Elâzığ, 23119
Local Institution - 362
Istanbul, 34093
Local Institution - 358
Istanbul, 34098
Local Institution - 361
Istanbul, 34668
Local Institution - 355
Istanbul, 34840
Local Institution - 354
Izmit/Kocaeli, 41380
Local Institution - 353
Kadiköy/Istanbul, 41380
Local Institution - 359
Trabzon, 61080
Mexico10 sites
Local Institution - 528
Chihuahua City, 31020
Local Institution - 527
México, 07020
Local Institution - 448
Mexico City, 6700
Local Institution - 532
Monterrey, Nuevo León, 64610
Local Institution - 525
Monterrey, Nuevo León, 64718
Local Institution - 447
Monterrey, Nuevo León, C.P 64000
Local Institution - 449
Monterrey, Nuevo León, C.P 64060
Local Institution - 529
Querétaro City, Querétaro, 76070
Local Institution - 530
Tlalpan, 14080
Local Institution - 526
Zapapan, Jalisco, 45030
Romania10 sites
Local Institution - 808
Bucharest, 010719
Local Institution - 836
Bucharest, 010719
Local Institution - 499
Bucharest, 013823
Local Institution - 795
Bucharest, 021494
Local Institution - 837
Bucharest, 022328
Local Institution - 839
Bucharest, 050098
Local Institution - 842
Bucharest, 10825
Local Institution - 838
Cluj-Napoca, 400001
Local Institution - 843
Craiova, 200642
Local Institution - 840
Târgu Mureş, 540136
Belgium8 sites
Local Institution - 943
Brasschaat, Antwerpen, 2930
Local Institution - 940
Brussels, 1090
Local Institution - 939
Edegem, 2650
Local Institution - 937
Ghent, 9000
Local Institution - 942
Leuven, 3000
Local Institution - 936
Liège, 4000
Local Institution - 938
Seraing, 4100
Local Institution - 941
Tournai, 7500
Greece8 sites
Local Institution - 790
Athens, 11 527
Local Institution - 588
Athens, 115 28
Local Institution - 791
Athens, 11527
Local Institution - 792
Athens, 18536
Local Institution - 592
Athens, Attiki, 15562
Local Institution - 787
Heraklion, 71 110
Local Institution - 789
Thessaloniki, 54642
Local Institution - 788
Thessaloniki, 56429
Taiwan8 sites
Local Institution - 460
Kaohsiung City, 82445
Local Institution - 463
Kaohsiung, San Ming Dist., 807
Local Institution - 363
Kozlu, 67000
Local Institution - 461
Niao-Sung Hsiang Kaohsiung County, 83301
Local Institution - 459
Tainan, Taiana, 704
Local Institution - 462
Taoyuan City, 33305
Local Institution - 465
Tapei, 10002
Local Institution - 464
Tapei, Beitou Dist., 11217
Slovakia7 sites
Local Institution - 900
Bratislava, 820 07
Local Institution - 894
Bratislava, 82606
Local Institution - 895
Brezno, 97701
Local Institution - 899
Nitra, 94901
Local Institution - 897
Nové Zámky, 94002
Local Institution - 898
Prešov, 080 01
Local Institution - 896
Rimavská Sobota, 979 01
South Africa7 sites
Local Institution - 543
Gauteng, 1820
Local Institution - 545
Kempton Park, 1619
Local Institution - 544
Pretoria, 0001
Local Institution - 542
Pretoria, 0084
Local Institution - 549
Pretoria, 0181
Local Institution - 548
Somerset West, 7130
Local Institution - 547
Val de Grace, 0184
Croatia6 sites
Local Institution - 453
Koprivnica, 48000
Local Institution - 763
Osijek, 31000
Local Institution - 765
Split, HR-21000
Local Institution - 452
Zagreb, 10000
Local Institution - 762
Zagreb, 10000
Local Institution - 766
Zagreb, 10000
Netherlands6 sites
Local Institution - 952
Amsterdam, 1081 HV
Local Institution - 955
Amsterdam, 1105 AZ
Local Institution - 956
Groningen, 9713 GZ
Local Institution - 949
Nijmegen, 6525 GA
Local Institution - 951
Sittard-Geleen, 6162 BG
Local Institution - 954
Tilburg, 5022 GC
Chile5 sites
Local Institution - 389
Concepción, 4070038
Local Institution - 392
Santiago, 7500010
Local Institution - 387
Santiago, 7500571
Local Institution - 391
Santiago, 7550000
Local Institution - 390
Santiago, 8320000
Colombia5 sites
Local Institution - 397
Armenia, Quindío Department, 630004
Local Institution - 398
Barranquilla, 080020
Local Institution - 395
Bogotá, 110221
Local Institution - 396
Cali, 760026
Local Institution - 394
Medellín, 050034
Lithuania5 sites
Local Institution - 605
Kaunas, LT-50009
Local Institution - 603
Klaipėda, LT-5808
Local Institution - 607
Vilnius, 08406
Local Institution - 606
Vilnius, LT-08661
Local Institution - 604
Vilnius, LT-10207
Austria4 sites
Local Institution - 726
Innsbruck, 6020
Local Institution - 727
Sankt Pölten, 3100
Local Institution - 336
Vienna, 1020
Local Institution - 725
Vienna, 1090
Bosnia and Herzegovina4 sites
Local Institution - 743
Banja Luka, 78000
Local Institution - 741
Mostar, 88000
Local Institution - 738
Sarajevo, 71000
Local Institution - 742
Sarajevo, 71000
Moldova4 sites
Local Institution - 811
Chisinau, MD-2068
Local Institution - 809
Chisinau, MD2025
Local Institution - 812
Chisinau, MD2025
Local Institution - 813
Chisinau, MD2025
Portugal4 sites
Local Institution - 959
Coimbra, 3000-075
Local Institution - 958
Guimarães, 4835-044
Local Institution - 961
Loures, 2674-514
Local Institution - 957
Viana do Castelo, 4904-858
Saudi Arabia4 sites
Local Institution - 534
Dammam, 32253
Local Institution - 537
Jeddah, 22252
Local Institution - 536
Riyadh, 12746
Local Institution - 535
Riyadh, 14611
Denmark3 sites
Local Institution - 611
Copenhagen, 2400
Local Institution - 610
Holbæk, 4300
Local Institution - 609
Nykøbing Falster, 4800
Latvia3 sites
Local Institution - 602
Riga, LV-1002
Local Institution - 601
Riga, LV-1006
Local Institution - 600
Riga, LV-1038
Switzerland3 sites
Local Institution - 967
Bern, 3001
Local Institution - 968
Sankt Gallen, 9007
Local Institution - 969
Zurich, 8091
Belarus2 sites
Local Institution - 745
Grodno, 230026
Local Institution - 737
Vitebsk, 210604
Finland2 sites
Local Institution - 613
Helsinki, 00290
Local Institution - 614
Turku, FI-20521
Hong Kong2 sites
Local Institution - 404
Hong Kong, 0
Local Institution - 405
Kowloon, 0
Ireland2 sites
Local Institution - 975
Dublin, Dublin, DO4 T6F4
Local Institution - 973
Dublin, D09 V2N0
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
- Conditions
- Crohn Disease
- Being tested
- Ozanimod, Placebo
- Keywords
- Crohn's Disease, Crohn Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3203
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod | Experimental | Not described Receives: Drug: Ozanimod |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed
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.
Measured: Week 52
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores
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.
Measured: Week 52
Secondary outcomes (15)
Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed
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.
Measured: Week 52
Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52
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.
Measured: Week 52
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1
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.
Measured: Week 52
Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1
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.
Measured: Week 52
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases
The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Measured: Week 52
Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores
CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Measured: Week 52
Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52
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.
Measured: Week 52
Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52
CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Measured: Week 52
Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases
CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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.
Measured: Week 52
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1
CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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.
Measured: Week 52
Percentage of Participants With Mucosal Healing (SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore > 1 Point) and Histologic Improvement Based on Robarts Histologic Index (RHI) at Week 52
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.
Measured: Week 52
Time to Relapse (an Increase in CDAI Score From Maintenance Day 1 ≥100 Points and CDAI Score >220, SES-CD ≥ 6 [or ≥4 if Isolated Ileal Disease]), and Exclusion of Other Causes of an Increase in Disease Activity Unrelated to Underlying CD
CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Measured: Week 52
Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline ≥ 50% at Week 52
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.
Measured: Week 52
Percentage of Participants With CDAI Score < 150 at Week 52 and at ≥ 80% of Visits Between Week 8 and Week 52, Inclusive, in Participants With CDAI Score < 150 at Maintenance Day 1
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.
Measured: Week 52
Percentage 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 and SES-CD Decrease From Baseline ≥ 50% at Week 52
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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start27 Jun 2018
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Why it stopped: The study has terminated due to non-safety reasons; Business Objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464097
- Sponsor's protocol ID
- RPC01-3203
- Other IDs
- U1111-1203-8002, 2023-510426-33, 2023
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2018
- Last updated
- 9 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.
PubMed 36208720
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT03464097
- Acronym / sponsor ID
- RPC01-3203
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, Crohn Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3203
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has terminated due to non-safety reasons; Business Objectives have changed.
- Enrolment
- 550 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Posted 9 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozanimod | Experimental | Drug: Ozanimod |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
- In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study
Key exclusion criteria (3 listed)
- Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
- Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodSpecified dose on specified days | Drug | Ozanimod |
| PlaceboSpecified dose on specified days | Other | Placebo |
Primary outcome
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed
Time frame: Week 52
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.
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores
Time frame: Week 52
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.
15 secondary outcomes
Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed
Time frame: Week 52
Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52
Time frame: Week 52
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1
Time frame: Week 52
Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1
Time frame: Week 52
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases
Time frame: Week 52
Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores
Time frame: Week 52
Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52
Time frame: Week 52
Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52
Time frame: Week 52
Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases
Time frame: Week 52
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1
Time frame: Week 52
Percentage of Participants With Mucosal Healing (SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore > 1 Point) and Histologic Improvement Based on Robarts Histologic Index (RHI) at Week 52
Time frame: Week 52
Time to Relapse (an Increase in CDAI Score From Maintenance Day 1 ≥100 Points and CDAI Score >220, SES-CD ≥ 6 [or ≥4 if Isolated Ileal Disease]), and Exclusion of Other Causes of an Increase in Disease Activity Unrelated to Underlying CD
Time frame: Week 52
Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline ≥ 50% at Week 52
Time frame: Week 52
Percentage of Participants With CDAI Score < 150 at Week 52 and at ≥ 80% of Visits Between Week 8 and Week 52, Inclusive, in Participants With CDAI Score < 150 at Maintenance Day 1
Time frame: Week 52
Percentage 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 and SES-CD Decrease From Baseline ≥ 50% at Week 52
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36208720Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
765 sites in 49 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ozanimod in people with Crohn Disease, run by Celgene at 765 sites in 49 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 765 sites in United States, Poland, Russia, Ukraine, China and 44 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed (time frame: Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03464097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.