Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
3 other identifiers
interventional
606
27 countries
344
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2018
Longer than P75 for phase_3
344 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedStudy Start
First participant enrolled
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2023
CompletedResults Posted
Study results publicly available
December 5, 2024
CompletedDecember 5, 2024
November 1, 2024
5.7 years
February 14, 2018
November 11, 2024
November 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Week 12
Secondary Outcomes (12)
Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission
Week 12
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%
Week 12
Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150
Week 12
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%
Week 12
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%
Week 12
- +7 more secondary outcomes
Study Arms (2)
Administration of oral Ozanimod
EXPERIMENTALAdministration of Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Crohn's disease for ≥ 3 months on endoscopy and on histological exam
- Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
- Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
- Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
- Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
You may not qualify if:
- Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
- Extensive small bowel resection (\>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
- Current stoma, ileal-anal pouch anastomosis, or fistula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (368)
Local Institution - 202
Scottsdale, Arizona, 85258, United States
Ucsd Medical Center
La Jolla, California, 92037, United States
Local Institution - 010
Lancaster, California, 93534, United States
Southern California Research Institute Medical Group, Inc.
Los Angeles, California, 90045, United States
Matrix Clinical Research Inc
Los Angeles, California, 90048, United States
Facey Medical Foundation (Parent)
Mission Hills, California, 91345, United States
Local Institution - 093
Pasadena, California, 91105, United States
Sutter Medical Group
Roseville, California, 95661, United States
Local Institution - 280
Sacramento, California, 95817, United States
Local Institution - 281
San Francisco, California, 94158, United States
Local Institution - 124
West Covina, California, 91790, United States
Local Institution - 065
Colorado Springs, Colorado, 80907, United States
Local Institution - 182
Bristol, Connecticut, 06010, United States
Local Institution - 166
Clearwater, Florida, 33765, United States
Local Institution - 084
Clermont, Florida, 34711, United States
American Research Institute Inc
Cutler Bay, Florida, 33157, United States
Local Institution - 112
Doral, Florida, 33166, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
SIH Research
Kissimmee, Florida, 34759, United States
Local Institution - 067
Lighthouse PT, Florida, 33064, United States
Center For Advanced Gastroenterology
Maitland, Florida, 32751, United States
LMG Research
Miami, Florida, 33125, United States
Local Institution - 175
Miami, Florida, 33166, United States
Local Institution - 081
Miami, Florida, 33176, United States
Local Institution - 044
Miami Springs, Florida, 33166, United States
Local Institution - 192
New Port Richey, Florida, 34655, United States
Local Institution - 200
Orlando, Florida, 32810, United States
Local Institution - 002
Palmetto Bay, Florida, 33157, United States
Theia Clinical Research, LLC
Pinellas Park, Florida, 33781, United States
Precision Clinical Research, LLC.
Sunrise, Florida, 33351, United States
Local Institution - 183
Tampa, Florida, 33612-4799, United States
Apex Clinical Research
Tampa, Florida, 33612, United States
Local Institution - 107
Tampa, Florida, 33614, United States
Local Institution - 037
Atlanta, Georgia, 30322, United States
Local Institution - 220
Atlanta, Georgia, 30322, United States
Local Institution - 143
Decatur, Georgia, 30030, United States
Local Institution - 115
Idaho Falls, Idaho, 83404, United States
Local Institution - 022
Chicago, Illinois, 60637, United States
Local Institution - 092
Evansville, Indiana, 47714, United States
Local Institution - 033
Indianapolis, Indiana, 46202, United States
Local Institution - 070
Topeka, Kansas, 66606, United States
Local Institution - 020
Baton Rouge, Louisiana, 70809, United States
Clinical Trials of SW Louisiana LLC
Lake Charles, Louisiana, 70601, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072, United States
Local Institution - 024
Worcester, Massachusetts, 01655, United States
Local Institution - 167
Kalamazoo, Michigan, 49008, United States
Local Institution - 005
Novi, Michigan, 48377, United States
Local Institution - 095
Minneapolis, Minnesota, 55455, United States
Local Institution - 045
Rochester, Minnesota, 55905, United States
Local Institution - 198
Kansas City, Missouri, 64111, United States
Internal Medicine Specialists
Las Vegas, Nevada, 89145, United States
Local Institution - 040
Lebanon, New Hampshire, 03756, United States
Local Institution - 054
Hartsdale, New York, 10530, United States
Weill Cornell Medical College
New York, New York, 10010, United States
Concorde Medical Group
New York, New York, 10016, United States
TrialSpark
New York, New York, 10024, United States
Local Institution - 060
North Massapequa, New York, 11758-1802, United States
Local Institution - 156
Charlotte, North Carolina, 28209, United States
Local Institution - 052
Winston-Salem, North Carolina, 27103, United States
Local Institution - 170
Dayton, Ohio, 45417, United States
Local Institution - 049
Hilliard, Ohio, 43026, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, 44130, United States
Local Institution - 087
Norman, Oklahoma, 73071, United States
Local Institution - 294
Oklahoma City, Oklahoma, 73102, United States
Local Institution - 185
Tulsa, Oklahoma, 74136, United States
Local Institution - 217
Tulsa, Oklahoma, 74137, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Local Institution - 034
Fort Sam Houston, Texas, 78234, United States
Local Institution - 079
Houston, Texas, 77058, United States
Local Institution - 196
Houston, Texas, 77089, United States
Gulf Coast Research Group LLC
Houston, Texas, 77098, United States
Accurate Clinical Research Inc
Pasadena, Texas, 77505, United States
Local Institution - 071
Richardson, Texas, 75082, United States
Local Institution - 178
San Antonio, Texas, 78229, United States
Local Institution - 181
Temple, Texas, 76508, United States
Local Institution - 292
Riverton, Utah, 84065, United States
Local Institution - 030
Lynchburg, Virginia, 24502, United States
The Gastroenterology Group
Reston, Virginia, 20191, United States
Local Institution - 072
Richmond, Virginia, 23249, United States
Local Institution - 172
Roanoke, Virginia, 24016, United States
Local Institution - 089
La Crosse, Wisconsin, 54601, United States
Local Institution - 309
Liverpool, New South Wales, 2170, Australia
Local Institution - 318
New Lambton Heights, New South Wales, 2305, Australia
Local Institution - 328
Herston, Queensland, 4029, Australia
Local Institution - 313
Maroorchydore, Queensland, 4558, Australia
Local Institution - 321
North Mackay, Queensland, 4740, Australia
Local Institution - 312
South Brisbane, Queensland, 4101, Australia
Local Institution - 307
Bedford Park, South Australia, 5042, Australia
Local Institution - 326
Elizabeth Vale, South Australia, 05112, Australia
Local Institution - 317
Clayton, Victoria, 3168, Australia
Local Institution - 305
Fitzroy, Victoria, 3065, Australia
Local Institution - 329
Geelong, Victoria, 3220, Australia
Local Institution - 327
Melbourne, Victoria, 3004, Australia
Local Institution - 315
Subiaco, Western Australia, 6008, Australia
Local Institution - 726
Innsbruck, 6020, Austria
Local Institution - 727
Sankt Pölten, 3100, Austria
Local Institution - 336
Vienna, 1020, Austria
Local Institution - 725
Vienna, 1090, Austria
Local Institution - 753
Rousse, 7002, Bulgaria
Local Institution - 750
Sofia, 1407, Bulgaria
Local Institution - 755
Sofia, 1407, Bulgaria
Local Institution - 756
Sofia, 1431, Bulgaria
Local Institution - 752
Sofia, 1527, Bulgaria
Local Institution - 554
Sofia, 1784, Bulgaria
Local Institution - 269
Edmonton, Alberta, T5R1W2, Canada
Local Institution - 262
New Westminster, British Columbia, V3L 3W5, Canada
Local Institution - 267
Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution - 256
Brandon, Manitoba, R7A 0N7, Canada
Local Institution - 266
Greater Sudbury, Ontario, P3C 5K6, Canada
Local Institution - 264
Toronto, Ontario, M5G 1X5, Canada
Local Institution - 257
Toronto, Ontario, M5T 3A9, Canada
Local Institution - 254
Montreal, Quebec, H1T 2M4, Canada
Local Institution - 270
Ottawa, Quebec, K1H 8L6, Canada
Local Institution - 423
Changzhou, Jiangsu, 213003, China
Local Institution - 369
Shanghai, Shanghai Municipality, 200120, China
Local Institution - 482
Beijing, 100050, China
Local Institution - 467
Beijing, 100700, China
Local Institution - 379
Bengbu, 233004, China
Local Institution - 485
Changchun, 130021, China
Local Institution - 376
Changchun, 130033, China
Local Institution - 421
Changsha, 410008, China
Local Institution - 378
Changsha, 450052, China
Local Institution - 414
Changzhou, 213004, China
Local Institution - 419
Chengdu, 610041, China
Local Institution - 422
Fuzhou, 350005, China
Local Institution - 478
Guangzhou, 510030, China
Local Institution - 472
Guangzhou, 510180, China
Local Institution - 486
Guangzhou, 510655, China
Local Institution - 470
Hangzhou, Zhejiang, 100142, China
Local Institution - 491
Hefei, 230001, China
Local Institution - 374
Kunming, 650032, China
Local Institution - 383
Luzhou, 646099, China
Local Institution - 488
Nanchang, 330006, China
Local Institution - 418
Nanjing, 210008, China
Local Institution - 375
Nanjing, 210009, China
Local Institution - 487
Nanjing, 210029, China
Local Institution - 473
Shanghai, 200025, China
Local Institution - 380
Shanghai, 200040, China
Local Institution - 377
Shanghai, 200080, China
Local Institution - 458
Taichung City, 40447, China
Local Institution - 373
Tianjin, 300052, China
Local Institution - 475
Wuhan, 430022, China
Local Institution - 474
Wuhan, 430030, China
Local Institution - 483
Wuhan, 430060, China
Local Institution - 381
Wuxi, 214023, China
Local Institution - 415
Xi'an, 710038, China
Local Institution - 420
Xi'an, 710100, China
Local Institution - 370
Zhengzhou, 450014, China
Local Institution - 397
Armenia, 630004, Colombia
Local Institution - 398
Barranquilla, 080020, Colombia
Local Institution - 395
Bogotá, 110221, Colombia
Local Institution - 396
Cali, 760026, Colombia
Local Institution - 394
Medellín, 050034, Colombia
Local Institution - 613
Helsinki, 00290, Finland
Local Institution - 614
Turku, FI-20521, Finland
Local Institution - 647
Neuilly-sur-Seine, Cedex, 92200, France
Local Institution - 639
Béziers, 34525, France
Local Institution - 635
Blois, 41016, France
Local Institution - 634
Caen, 14000, France
Local Institution - 644
Colombes, 92701, France
Local Institution - 632
Nantes, 44093, France
Local Institution - 630
Pierre-Bénite, 69495, France
Local Institution - 631
Saint-Priest-en-Jarez, 42270, France
Local Institution - 786
Batumi, 6010, Georgia
Local Institution - 779
Kutaisi, 4600, Georgia
Local Institution - 454
Tbilisi, 0101, Georgia
Local Institution - 778
Tbilisi, 0112, Georgia
Local Institution - 782
Tbilisi, 0131, Georgia
Local Institution - 552
Tbilisi, 0144, Georgia
Local Institution - 793
Tbilisi, 0159, Georgia
Local Institution - 740
Tbilisi, 0160, Georgia
Local Institution - 783
Tbilisi, 0160, Georgia
Local Institution - 784
Tbilisi, 0160, Georgia
Local Institution - 785
Tbilisi, 0160, Georgia
Local Institution - 335
Tbilisi, 0179, Georgia
Local Institution - 455
Tbilisi, 0180, Georgia
Local Institution - 781
Tbilisi, 0186, Georgia
Local Institution - 780
Telavi, 2200, Georgia
Local Institution - 629
Berlin, 10787, Germany
Local Institution - 653
Berlin, 12200, Germany
Local Institution - 648
Berlin, 13353, Germany
Local Institution - 628
Berlin, 14163, Germany
Local Institution - 664
Brandenburg, 14770, Germany
Local Institution - 732
Dachau, 85221, Germany
Local Institution - 574
Frankfurt am Main, 60313, Germany
Local Institution - 657
Frankfurt am Main, 60590, Germany
Local Institution - 658
Halle, 06108, Germany
Local Institution - 656
Halle, 06120, Germany
Local Institution - 652
Hamburg, 22559, Germany
Local Institution - 591
Hanover, 30625, Germany
Local Institution - 649
Keil, 24105, Germany
Local Institution - 337
Leipzig, 04103, Germany
Local Institution - 660
Mainz, 55131, Germany
Local Institution - 667
Münster, 48149, Germany
Local Institution - 620
Neuruppin, 16816, Germany
Local Institution - 584
Nürtingen, 72622, Germany
Local Institution - 661
Stuttgart, 70376, Germany
Local Institution - 790
Athens, 11 527, Greece
Local Institution - 588
Athens, 115 28, Greece
Local Institution - 791
Athens, 11527, Greece
Local Institution - 792
Athens, 18536, Greece
Local Institution - 592
Athens, Attiki, 15562, Greece
Local Institution - 787
Heraklion, 71 110, Greece
Local Institution - 789
Thessaloniki, 54642, Greece
Local Institution - 788
Thessaloniki, 56429, Greece
Local Institution - 404
Hong Kong, 0, Hong Kong
Local Institution - 405
Kowloon, 0, Hong Kong
Local Institution - 798
Békéscsaba, 5600, Hungary
Local Institution - 803
Budapest, 1062, Hungary
Local Institution - 804
Budapest, 1088, Hungary
Local Institution - 556
Budapest, H-1036, Hungary
Local Institution - 801
Győr, 9024, Hungary
Local Institution - 555
Gyula, 5700, Hungary
Local Institution - 797
Miskolc, 3529, Hungary
Local Institution - 800
Nagykanizsa, H-8800, Hungary
Local Institution - 816
Szekszárd, 7100, Hungary
Local Institution - 805
Szentes, 6600, Hungary
Local Institution - 799
Székesfehérvár, 8000, Hungary
Local Institution - 343
Afula, 18341, Israel
Local Institution - 346
Beer Jacob, 73100, Israel
Local Institution - 350
Haifa, 3109601, Israel
Local Institution - 347
Jerusalem, 9362410, Israel
Local Institution - 349
Kfar Saba, 44281, Israel
Local Institution - 341
Petah Tikva, 49100, Israel
Local Institution - 340
Tel Aviv, 64239, Israel
Local Institution - 605
Kaunas, LT-50009, Lithuania
Local Institution - 603
Klaipėda, LT-5808, Lithuania
Local Institution - 607
Vilnius, 08406, Lithuania
Local Institution - 606
Vilnius, LT-08661, Lithuania
Local Institution - 604
Vilnius, LT-10207, Lithuania
Local Institution - 952
Amsterdam, 1081 HV, Netherlands
Local Institution - 955
Amsterdam, 1105 AZ, Netherlands
Local Institution - 956
Groningen, 9713 GZ, Netherlands
Local Institution - 949
Nijmegen, 6525 GA, Netherlands
Local Institution - 951
Sittard-Geleen, 6162 BG, Netherlands
Local Institution - 954
Tilburg, 5022 GC, Netherlands
Local Institution - 580
Częstochowa, 42-202, Poland
Local Institution - 988
Elblag, 82-300, Poland
Local Institution - 579
Gdansk, 80-382, Poland
Local Institution - 978
Gdansk, 80-803, Poland
Local Institution - 577
Gdynia, 81-537, Poland
Local Institution - 906
Jelenia Góra, 58-500, Poland
Local Institution - 757
Józefów, 05-410, Poland
Local Institution - 578
Katowice, 40-040, Poland
Local Institution - 834
Ksawerów, 95-054, Poland
Local Institution - 581
Lodz, 90-127, Poland
Local Institution - 981
Lodz, 93-034, Poland
Local Institution - 976
Nowy Targ, 34-400, Poland
Local Institution - 963
Rzeszów, 35-302, Poland
Local Institution - 979
Sopot, 81-756, Poland
Local Institution - 835
Szczecin, 71-270, Poland
Local Institution - 586
Warsaw, 00-728, Poland
Local Institution - 833
Warsaw, 02-018, Poland
Local Institution - 989
Warsaw, 02-653, Poland
Local Institution - 807
Warsaw, 04-730, Poland
Local Institution - 893
Wierzchosławice, 33-122, Poland
Local Institution - 983
Wroclaw, 50-053, Poland
Local Institution - 984
Wroclaw, 50-367, Poland
Local Institution - 582
Wroclaw, 50-381, Poland
Local Institution - 982
Wroclaw, 51-162, Poland
Local Institution - 831
Wroclaw, 53-114, Poland
Local Institution - 987
Wroclaw, 53-333, Poland
Local Institution - 832
Wroclaw, 54-144, Poland
Local Institution - 959
Coimbra, 3000-075, Portugal
Local Institution - 958
Guimarães, 4835-044, Portugal
Local Institution - 961
Loures, 2674-514, Portugal
Local Institution - 957
Viana do Castelo, 4904-858, Portugal
Local Institution - 966
Barnaul, 656015, Russia
Local Institution - 871
Barnaul, 656024, Russia
Local Institution - 589
Bataysk, 346880, Russia
Local Institution - 621
Chelyabinsk, 454021, Russia
Local Institution - 991
Chelyabinsk, 454076, Russia
Local Institution - 998
Kaliningrad, 236016, Russia
Local Institution - 882
Kaluga, 248007, Russia
Local Institution - 849
Kemerovo, 650066, Russia
Local Institution - 566
Moscow, 105554, Russia
Local Institution - 995
Moscow, 115516, Russia
Local Institution - 873
Moscow, 117997, Russia
Local Institution - 870
Moscow, 119192, Russia
Local Institution - 869
Moscow, 123423, Russia
Local Institution - 990
Nizhny Novgorod, 603140, Russia
Local Institution - 853
Novosibirsk, 630091, Russia
Local Institution - 876
Novosibirsk, 630117, Russia
Local Institution - 996
Omsk, 644024, Russia
Local Institution - 875
Orenburg, 460050, Russia
Local Institution - 867
Penza, 440026, Russia
Local Institution - 863
Saint Petersburg, 191015, Russia
Local Institution - 993
Saint Petersburg, 191015, Russia
Local Institution - 868
Saint Petersburg, 194044, Russia
Local Institution - 857
Saint Petersburg, 195009, Russia
Local Institution - 879
Saint Petersburg, 196143, Russia
Local Institution - 878
Saint Petersburg, 196247, Russia
Local Institution - 874
Saint Petersburg, 197110, Russia
Local Institution - 865
Samara, 443001, Russia
Local Institution - 992
Saratov, 410053, Russia
Local Institution - 866
Sochi, 354207, Russia
Local Institution - 877
Tomsk, 634063, Russia
Local Institution - 881
Ufa, 450005, Russia
Local Institution - 880
Volgograd, 400107, Russia
Local Institution - 583
Yekaterinburg, 620075, Russia
Local Institution - 872
Yekaterinburg, 620109, Russia
Local Institution - 546
Cape Town, 7500, Senegal
Local Institution - 887
Belgrade, 11 080, Serbia
Local Institution - 596
Belgrade, 11000, Serbia
Local Institution - 886
Belgrade, 11000, Serbia
Local Institution - 890
Belgrade, 11000, Serbia
Local Institution - 891
Kragujevac, 34000, Serbia
Local Institution - 884
Novi Sad, 21 000, Serbia
Local Institution - 885
Pančevo, 26000, Serbia
Local Institution - 585
Vršac, 26300, Serbia
Local Institution - 889
Zrenjanin, 23 000, Serbia
Local Institution - 900
Bratislava, 820 07, Slovakia
Local Institution - 894
Bratislava, 82606, Slovakia
Local Institution - 895
Brezno, 97701, Slovakia
Local Institution - 899
Nitra, 94901, Slovakia
Local Institution - 897
Nové Zámky, 94002, Slovakia
Local Institution - 898
Prešov, 080 01, Slovakia
Local Institution - 896
Rimavská Sobota, 979 01, Slovakia
Local Institution - 904
Celje, 3000, Slovenia
Local Institution - 543
Gauteng, 1820, South Africa
Local Institution - 545
Kempton Park, 1619, South Africa
Local Institution - 544
Pretoria, 0001, South Africa
Local Institution - 542
Pretoria, 0084, South Africa
Local Institution - 549
Pretoria, 0181, South Africa
Local Institution - 548
Somerset West, 7130, South Africa
Local Institution - 547
Val de Grace, 0184, South Africa
Local Institution - 434
Busan, 49241, South Korea
Local Institution - 431
Busan, 612-030, South Korea
Local Institution - 432
Daegu, 705-030, South Korea
Local Institution - 438
Seoul, 3080, South Korea
Local Institution - 429
Suwon, 442723, South Korea
Teknon Medical Center
Barcelona, 08022, Spain
University Hospital Reina Sofia
Córdoba, 14001, Spain
University Hospital of Girona Dr. Josep Trueta
Girona, 17007, Spain
Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35012, Spain
Local Institution - 695
Madrid, 28040, Spain
University Hospital Puerta de Hierro Majadajonda
Majadahonda, Madrid, 28222, Spain
University Hospital Marques de Valdecilla (HUMV)
Santander, 39008, Spain
Local Institution - 697
Valencia, 46010, Spain
Local Institution - 625
Stockholm, 112 81, Sweden
Local Institution - 460
Kaohsiung City, 82445, Taiwan
Local Institution - 463
Kaohsiung, San Ming Dist., 807, Taiwan
Local Institution - 461
Niao-Sung Hsiang Kaohsiung County, 83301, Taiwan
Local Institution - 459
Tainan, Taiana, 704, Taiwan
Local Institution - 462
Taoyuan, 33305, Taiwan
Local Institution - 464
Tapei, Beitou Dist., 11217, Taiwan
Local Institution - 465
Tapei, 10002, Taiwan
Local Institution - 357
Ankara, 01660, Turkey (Türkiye)
Local Institution - 365
Elâzığ, 23119, Turkey (Türkiye)
Local Institution - 358
Istanbul, 34098, Turkey (Türkiye)
Local Institution - 361
Istanbul, 34668, Turkey (Türkiye)
Local Institution - 353
Kadiköy/Istanbul, 41380, Turkey (Türkiye)
Local Institution - 922
Chernivtsi, 58001, Ukraine
Local Institution - 929
Ivano-Frankivsk, 76008, Ukraine
Local Institution - 965
Kharkiv, 61037, Ukraine
Local Institution - 920
Khmelnytskyi, 29000, Ukraine
Local Institution - 933
Kropyvnytskyi, 25006, Ukraine
Local Institution - 923
Kyiv, 01601, Ukraine
Local Institution - 563
Kyiv, 02002, Ukraine
Local Institution - 564
Kyiv, 03037, Ukraine
Local Institution - 977
Kyiv, 04107, Ukraine
Local Institution - 590
Lutsk, 43005, Ukraine
Local Institution - 974
Lviv, 79010, Ukraine
Local Institution - 902
Odesa, 65025, Ukraine
Local Institution - 932
Vinnytsia, 21009, Ukraine
Local Institution - 924
Vinnytsia, 21018, Ukraine
Local Institution - 587
Zaporizhia, 69063, Ukraine
Local Institution - 925
Zaporizhzhya, 69600, Ukraine
Related Publications (1)
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.
PMID: 36208720DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2018
First Posted
February 22, 2018
Study Start
March 7, 2018
Primary Completion
November 21, 2023
Study Completion
November 21, 2023
Last Updated
December 5, 2024
Results First Posted
December 5, 2024
Record last verified: 2024-11