NCT03440372

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

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
625

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_3

Geographic Reach
34 countries

400 active sites

Status
terminated

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 4, 2025

Completed
Last Updated

November 4, 2025

Status Verified

October 1, 2025

Enrollment Period

6.6 years

First QC Date

February 14, 2018

Results QC Date

September 18, 2025

Last Update Submit

October 21, 2025

Conditions

Keywords

Crohn's DiseaseCrohn DiseaseOralOzanimodModerately activeSeverely activeRPC01RPC01-3201

Outcome Measures

Primary Outcomes (1)

  • Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12

    Crohn's Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn's disease. CDAI uses 8 variables: number of soft/liquid stools, severity of abdominal pain (0=none to 3=severe), general well-being (0=well to 4=terrible), presence of complications, need for antidiarrheal drugs, presence of abdominal mass, hematocrit, and change in body weight. Scores for stool number, abdominal pain, and well-being are summed over the 7 days before each visit. The other factors are also recorded and weighted to create a total CDAI score, which ranges from 0-600, with higher scores indicating worse disease (score 150-219 = mild, 220-450 = moderate, \>450 = severe). This measure reports the percentage of participants whose CDAI score was below 150 at 12 weeks.

    At Week 12

Secondary Outcomes (11)

  • Percent of Participants With Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12

    At Week 12

  • Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12

    At Week 12

  • Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12

    At Week 12

  • Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12

    At Week 12

  • Percent of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12

    At Week 12

  • +6 more secondary outcomes

Study Arms (2)

Administration of oral Ozanimod

EXPERIMENTAL
Drug: Ozanimod

Administration of Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Specified dose on specified days

Administration of oral Ozanimod
PlaceboOTHER

Specified dose on specified days

Administration of Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (408)

Holland Center for Family Health

Peoria, Arizona, 85381, United States

Location

Local Institution - 026

North Little Rock, Arkansas, 72117, United States

Location

Local Institution - 284

Camarillo, California, 93012, United States

Location

Local Institution - 165

Chula Vista, California, 91911, United States

Location

Local Institution - 039

Garden Grove, California, 92843, United States

Location

San Diego Clinical Trials

La Mesa, California, 91942, United States

Location

Local Institution - 061

Los Angeles, California, 90027, United States

Location

Local Institution - 110

Los Angeles, California, 90067, United States

Location

Local Institution - 140

Mission Viejo, California, 92691, United States

Location

Alliance Clinical Research

Oceanside, California, 92056, United States

Location

Local Institution - 027

Orange, California, 92868, United States

Location

Palo Alto Center-Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94304, United States

Location

Local Institution - 006

Rialto, California, 92377, United States

Location

Local Institution - 003

San Diego, California, 92123, United States

Location

Local Institution - 297

Lakewood, Colorado, 80228, United States

Location

Local Institution - 225

Bristol, Connecticut, 06010, United States

Location

Local Institution - 091

New Haven, Connecticut, 06510, United States

Location

Local Institution - 062

Clearwater, Florida, 33756-3839, United States

Location

Local Institution - 218

Gainesville, Florida, 32608, United States

Location

Local Institution - 203

Hialeah, Florida, 33010, United States

Location

Harmony Medical Research Institute

Hialeah, Florida, 33016, United States

Location

Local Institution - 078

Hialeah, Florida, 33016, United States

Location

Local Institution - 179

Hollywood, Florida, 33021, United States

Location

Local Institution - 101

Homestead, Florida, 33033, United States

Location

Local Institution - 016

Largo, Florida, 33777, United States

Location

Local Institution - 199

Miami, Florida, 33125, United States

Location

LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

Location

Local Institution - 169

Miami, Florida, 33156, United States

Location

Local Institution - 090

Naples, Florida, 34109, United States

Location

Local Institution - 214

New Smyrna Beach, Florida, 32168, United States

Location

Local Institution - 076

Orlando, Florida, 32819, United States

Location

Local Institution - 098

Port Orange, Florida, 32127, United States

Location

Local Institution - 226

Tampa, Florida, 33612, United States

Location

Local Institution - 149

Tampa, Florida, 33614, United States

Location

Local Institution - 114

Weeki Wachee, Florida, 34607, United States

Location

Local Institution - 205

Atlanta, Georgia, 30308, United States

Location

Local Institution - 222

Atlanta, Georgia, 30322, United States

Location

Local Institution - 019

Atlanta, Georgia, 30342, United States

Location

Local Institution - 063

Atlanta, Georgia, 30342, United States

Location

Local Institution - 074

Columbus, Georgia, 31904, United States

Location

Local Institution - 028

Macon, Georgia, 31201, United States

Location

Local Institution - 194

Chicago, Illinois, 60612, United States

Location

Local Institution - 036

Chicago, Illinois, 60622, United States

Location

Local Institution - 146

Urbana, Illinois, 61801, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325, United States

Location

Local Institution - 155

Lexington, Kentucky, 40536-0298, United States

Location

CroNOLA LLC

Houma, Louisiana, 70360, United States

Location

Local Institution - 053

Lake Charles, Louisiana, 70601, United States

Location

Local Institution - 104

New Orleans, Louisiana, 70125, United States

Location

Local Institution - 278

Baltimore, Maryland, 21224, United States

Location

Local Institution - 129

Catonsville, Maryland, 21228, United States

Location

Local Institution - 282

Glen Burnie, Maryland, 21061, United States

Location

Local Institution - 142

Chestnut Hill, Massachusetts, 02467, United States

Location

Local Institution - 228

North Worcester, Massachusetts, 01655, United States

Location

Local Institution - 286

Springfield, Massachusetts, 01199, United States

Location

Local Institution - 191

Caro, Michigan, 48723, United States

Location

Local Institution - 108

Southfield, Michigan, 48034, United States

Location

Local Institution - 301

Wyoming, Michigan, 49519, United States

Location

Local Institution - 300

Ypsilanti, Michigan, 48197, United States

Location

Local Institution - 274

Jackson, Mississippi, 39216, United States

Location

Local Institution - 029

St Louis, Missouri, 63110, United States

Location

Local Institution - 215

Englewood, New Jersey, 07631, United States

Location

Local Institution - 144

Brooklyn, New York, 11235, United States

Location

Local Institution - 009

Great Neck, New York, 11021, United States

Location

Local Institution - 105

New York, New York, 10021, United States

Location

Local Institution - 043

New York, New York, 10075, United States

Location

Local Institution - 094

Orchard Park, New York, 14127, United States

Location

Advantage Clinical Trials

The Bronx, New York, 10468, United States

Location

Local Institution - 017

Asheville, North Carolina, 28801, United States

Location

Local Institution - 152

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 055

Charlotte, North Carolina, 28207, United States

Location

Local Institution - 133

Greenville, North Carolina, 27834, United States

Location

Local Institution - 302

Raleigh, North Carolina, 27612, United States

Location

Local Institution - 210

Beachwood, Ohio, 44122, United States

Location

Local Institution - 291

Cincinnati, Ohio, 45219, United States

Location

Local Institution - 018

Cleveland, Ohio, 44195, United States

Location

Local Institution - 177

Mentor, Ohio, 44060, United States

Location

Local Institution - 211

Warren, Ohio, 44483, United States

Location

Local Institution - 208

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 131

Oklahoma City, Oklahoma, 73112, United States

Location

Local Institution - 113

Portland, Oregon, 97239, United States

Location

Local Institution - 197

Hershey, Pennsylvania, 17033, United States

Location

Penn State University Milton S Hershey Medical Center

State College, Pennsylvania, 16803, United States

Location

Local Institution - 253

Providence, Rhode Island, 02904, United States

Location

Local Institution - 289

Charleston, South Carolina, 29425, United States

Location

Local Institution - 121

Nashville, Tennessee, 37211, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Advanced Gastroenterology

Union City, Tennessee, 38261, United States

Location

Local Institution - 158

Austin, Texas, 78742, United States

Location

Local Institution - 056

Houston, Texas, 77030, United States

Location

Local Institution - 150

Houston, Texas, 77030, United States

Location

Local Institution - 102

Houston, Texas, 77043, United States

Location

Local Institution - 082

Houston, Texas, 77070, United States

Location

Local Institution - 303

Houston, Texas, 77074, United States

Location

Local Institution - 088

Houston, Texas, 77084, United States

Location

Local Institution - 085

San Antonio, Texas, 78215, United States

Location

Local Institution - 223

San Antonio, Texas, 78229, United States

Location

Local Institution - 007

Southlake, Texas, 76092, United States

Location

Local Institution - 073

Tyler, Texas, 75701, United States

Location

Local Institution - 025

Salt Lake City, Utah, 84132, United States

Location

Local Institution - 189

Gainesville, Virginia, 20155, United States

Location

Local Institution - 298

Manassas, Virginia, 20110, United States

Location

Local Institution - 139

Petersburg, Virginia, 23805, United States

Location

Virginia Gastroenterology Institute PC

Suffolk, Virginia, 23434, United States

Location

Local Institution - 296

Williamsburg, Virginia, 23188, United States

Location

Local Institution - 125

Spokane, Washington, 99204, United States

Location

Aurora Health Care Aurora Research

Grafton, Wisconsin, 53024, United States

Location

Local Institution - 501

Buenos Aires, 0, Argentina

Location

Local Institution - 494

Buenos Aires, 1180, Argentina

Location

Local Institution - 571

Buenos Aires, 1702, Argentina

Location

Local Institution - 500

Buenos Aires, B1878, Argentina

Location

Local Institution - 570

CĂ³rdoba, X5003DCE, Argentina

Location

Local Institution - 495

CĂ³rdoba, X5016, Argentina

Location

Local Institution - 569

Mar del Plata, B7600, Argentina

Location

Local Institution - 496

Rosario, 2000, Argentina

Location

Local Institution - 497

Rosario, 2000, Argentina

Location

Local Institution - 502

Rosario, Santa Fe, S2002, Argentina

Location

Local Institution - 492

San Miguel de TucumĂ¡n, 4000, Argentina

Location

Local Institution - 310

Concord, New South Wales, 2139, Australia

Location

Local Institution - 319

Kingswood, New South Wales, 2747, Australia

Location

Local Institution - 323

Wollongong, New South Wales, 2500, Australia

Location

Local Institution - 707

Maroochydore, Queensland, 4558, Australia

Location

Local Institution - 311

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 308

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 708

Adelaide, South Australia, 5112, Australia

Location

Local Institution - 320

Woodville South, South Australia, 5011, Australia

Location

Local Institution - 709

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 316

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 325

Bankstown, 2200, Australia

Location

Local Institution - 330

Box Hill, 3128, Australia

Location

Local Institution - 324

Sydney, NSW, NSW 2050, Australia

Location

Local Institution - 745

Grodno, 230026, Belarus

Location

Local Institution - 737

Vitebsk, 210604, Belarus

Location

Local Institution - 943

Brasschaat, Antwerpen, 2930, Belgium

Location

Local Institution - 940

Brussels, 1090, Belgium

Location

Local Institution - 939

Edegem, 2650, Belgium

Location

Local Institution - 937

Ghent, 9000, Belgium

Location

Local Institution - 942

Leuven, 3000, Belgium

Location

Local Institution - 936

Liège, 4000, Belgium

Location

Local Institution - 938

Seraing, 4100, Belgium

Location

Local Institution - 941

Tournai, 7500, Belgium

Location

Local Institution - 743

Banja Luka, 78000, Bosnia and Herzegovina

Location

Local Institution - 741

Mostar, 88000, Bosnia and Herzegovina

Location

Local Institution - 738

Sarajevo, 71000, Bosnia and Herzegovina

Location

Local Institution - 742

Sarajevo, 71000, Bosnia and Herzegovina

Location

Local Institution - 456

Blagoevgrad, 2700, Bulgaria

Location

Local Institution - 746

Plovdiv, 4002, Bulgaria

Location

Local Institution - 747

Sofia, 1202, Bulgaria

Location

Local Institution - 627

Sofia, 1527, Bulgaria

Location

Local Institution - 749

Sofia, 1606, Bulgaria

Location

Local Institution - 748

Sofia, 1784, Bulgaria

Location

Local Institution - 553

Stara Zagora, 6000, Bulgaria

Location

Local Institution - 754

Varna, 9002, Bulgaria

Location

Local Institution - 273

Calgary, Alberta, T2N 4Z6, Canada

Location

Local Institution - 227

Edmonton, Alberta, T5R 1W2, Canada

Location

Local Institution - 263

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Local Institution - 255

Vancouver, British Columbia, V5Z1M9, Canada

Location

Local Institution - 261

Winnipeg, Manitoba, R3CON2, Canada

Location

Local Institution - 268

Bridgewater, Nova Scotia, B4V 3N2, Canada

Location

Local Institution - 252

London, Ontario, N6A 5A5, Canada

Location

Local Institution - 251

London, Ontario, N6A 5W9, Canada

Location

Local Institution - 275

Toronto, Ontario, M5G 1X8, Canada

Location

Local Institution - 271

Vaughan, Ontario, L4L 4Y7, Canada

Location

Local Institution - 389

ConcepciĂ³n, 4070038, Chile

Location

Local Institution - 392

Santiago, 7500010, Chile

Location

Local Institution - 387

Santiago, 7500571, Chile

Location

Local Institution - 391

Santiago, 7550000, Chile

Location

Local Institution - 390

Santiago, 8320000, Chile

Location

Local Institution - 453

Koprivnica, 48000, Croatia

Location

Local Institution - 763

Osijek, 31000, Croatia

Location

Local Institution - 764

Rijeka, 51000, Croatia

Location

Local Institution - 765

Split, HR-21000, Croatia

Location

Local Institution - 452

Zagreb, 10000, Croatia

Location

Local Institution - 761

Zagreb, 10000, Croatia

Location

Local Institution - 762

Zagreb, 10000, Croatia

Location

Local Institution - 766

Zagreb, 10000, Croatia

Location

Local Institution - 767

Brno, 615 00, Czechia

Location

Local Institution - 772

Brno, 656 91, Czechia

Location

Local Institution - 773

Hradec KrĂ¡lovĂ©, 500 12, Czechia

Location

Local Institution - 775

Most, 43401, Czechia

Location

Local Institution - 771

Olomouc, 77900, Czechia

Location

Local Institution - 774

Pardubice, 532 03, Czechia

Location

Local Institution - 769

Pilsen, 30460, Czechia

Location

Local Institution - 573

Prague, 120 00, Czechia

Location

Local Institution - 368

Prague, 14000, Czechia

Location

Local Institution - 776

Prague, 14021, Czechia

Location

Local Institution - 768

Prague, 150 06, Czechia

Location

Local Institution - 770

Prague, 190 00, Czechia

Location

Local Institution - 611

Copenhagen, 2400, Denmark

Location

Local Institution - 610

Holbæk, 4300, Denmark

Location

Local Institution - 609

Nykøbing Falster, 4800, Denmark

Location

Local Institution - 614

Turku, FI-20521, Finland

Location

Local Institution - 638

Amiens, 80054, France

Location

Local Institution - 711

Créteil, 94010, France

Location

Local Institution - 616

Dijon, 21079, France

Location

Local Institution - 615

Grenoble, 38700, France

Location

Local Institution - 633

Lillie Cedex, 59037, France

Location

Local Institution - 646

Marseille, 13915, France

Location

Local Institution - 507

Montpellier, 34295, France

Location

Local Institution - 641

Rennes, 35033, France

Location

Local Institution - 612

Rouen, 76031, France

Location

Local Institution - 643

Toulouse, 31059, France

Location

Local Institution - 248

Tbilisi, 0101, Georgia

Location

Local Institution - 247

Tbilisi, 0112, Georgia

Location

Local Institution - 249

Tbilisi, 0180, Georgia

Location

Local Institution - 626

Berlin, 10117, Germany

Location

Local Institution - 665

Berlin, 10825, Germany

Location

Local Institution - 650

Berlin, 14050, Germany

Location

Local Institution - 662

Frankfurt, 60431, Germany

Location

Local Institution - 654

Frankfurt, 60594, Germany

Location

Local Institution - 659

Hamburg, 20246, Germany

Location

Local Institution - 651

Leipzig, 04103, Germany

Location

Local Institution - 655

Ludwigshafen am Rhein, 67067, Germany

Location

Local Institution - 730

Ludwigshafen am Rhein, 67067, Germany

Location

Local Institution - 661

Stuttgart, 70376, Germany

Location

Local Institution - 666

TĂ¼bingen, 72076, Germany

Location

Local Institution - 663

Ulm, 89081, Germany

Location

Local Institution - 444

Hyderabad, Andhra Pradesh, 500084, India

Location

Local Institution - 407

Surat, Gujarat, 395002, India

Location

Local Institution - 332

Gurgaon, Haryana, 122002, India

Location

Local Institution - 445

Kochi, Kerala, 682041, India

Location

Local Institution - 446

Ludhiana, Punjab, 141001, India

Location

Local Institution - 443

Jaipur, Rajasthan, 302004, India

Location

Local Institution - 399

Jaipur, Rajasthan, 302006, India

Location

Local Institution - 408

Coimbatore, Tamil Nadu, 641044, India

Location

Local Institution - 331

Hyderabad, Telangana, 500032, India

Location

Local Institution - 457

Delhi, 110002, India

Location

Local Institution - 411

New Delhi, 110029, India

Location

Local Institution - 975

Dublin, Dublin, DO4 T6F4, Ireland

Location

Local Institution - 973

Dublin, D09 V2N0, Ireland

Location

Local Institution - 345

Bat Yam, 5962025, Israel

Location

Local Institution - 339

Jerusalem, 91031, Israel

Location

Local Institution - 344

Nahariya, 22100, Israel

Location

Local Institution - 342

Ramat Gan, 52621, Israel

Location

Local Institution - 338

Rehovot, 76100, Israel

Location

Local Institution - 677

Bologna, 40138, Italy

Location

Local Institution - 684

Brescia, 25123, Italy

Location

Local Institution - 688

Brescia, 25124, Italy

Location

Local Institution - 689

Castellana Grotte, 70013, Italy

Location

Local Institution - 679

Catanzaro, 88100, Italy

Location

Local Institution - 687

Chieti, 66100, Italy

Location

Local Institution - 674

Messina, 98125, Italy

Location

Local Institution - 672

Milan, 20089, Italy

Location

Local Institution - 686

Milan, 20122, Italy

Location

Local Institution - 334

Milan, 20132, Italy

Location

Local Institution - 678

Monza, 20900, Italy

Location

Local Institution - 685

Padua, 35128, Italy

Location

Local Institution - 682

Palermo, 90146, Italy

Location

Local Institution - 673

Pavia, 27100, Italy

Location

Local Institution - 681

Roma, 00133, Italy

Location

Local Institution - 675

Roma, 00168, Italy

Location

Local Institution - 671

Rome, 00152, Italy

Location

Local Institution - 680

Udine, 33100, Italy

Location

Local Institution - 670

Varese, 21100, Italy

Location

Local Institution - 676

Verona, 37024, Italy

Location

Local Institution - 602

Riga, LV-1002, Latvia

Location

Local Institution - 601

Riga, LV-1006, Latvia

Location

Local Institution - 600

Riga, LV-1038, Latvia

Location

Local Institution - 526

Zapapan, Jalisco, 45030, Mexico

Location

Local Institution - 532

Monterrey, Nuevo LeĂ³n, 64610, Mexico

Location

Local Institution - 525

Monterrey, Nuevo LeĂ³n, 64718, Mexico

Location

Local Institution - 447

Monterrey, Nuevo LeĂ³n, C.P 64000, Mexico

Location

Local Institution - 449

Monterrey, Nuevo LeĂ³n, C.P 64060, Mexico

Location

Local Institution - 529

Querétaro City, Querétaro, 76070, Mexico

Location

Local Institution - 528

Chihuahua City, 31020, Mexico

Location

Local Institution - 448

Mexico City, 6700, Mexico

Location

Local Institution - 527

México, 07020, Mexico

Location

Local Institution - 530

Tlalpan, 14080, Mexico

Location

Local Institution - 811

Chisinau, MD-2068, Moldova

Location

Local Institution - 810

Chisinau, MD2005, Moldova

Location

Local Institution - 809

Chisinau, MD2025, Moldova

Location

Local Institution - 812

Chisinau, MD2025, Moldova

Location

Local Institution - 813

Chisinau, MD2025, Moldova

Location

Local Institution - 403

Zamość, Lublin Voivodeship, 22-400, Poland

Location

Local Institution - 597

Zamość, Lublin Voivodeship, 22-400, Poland

Location

Local Institution - 820

Bialystok, 15-276, Poland

Location

Local Institution - 818

Bochnia, 32-700, Poland

Location

Local Institution - 238

Katowice, 40-040, Poland

Location

Local Institution - 828

Katowice, 40-660, Poland

Location

Local Institution - 819

Katowice, 40-752, Poland

Location

Local Institution - 815

Krakow, 30-363, Poland

Location

Local Institution - 823

Krakow, 31-156, Poland

Location

Local Institution - 826

Krakow, 31-501, Poland

Location

Local Institution - 817

Kłodzko, 57-300, Poland

Location

Local Institution - 829

Lodz, 90-302, Poland

Location

Local Institution - 888

Lodz, 91-839, Poland

Location

Local Institution - 760

Lublin, 20-049, Poland

Location

Local Institution - 830

Olsztyn, 10-561, Poland

Location

Local Institution - 402

Opole, 45-819, Poland

Location

Local Institution - 400

Oświęcim, 32-600, Poland

Location

Local Institution - 758

Poznan, 60-529, Poland

Location

Local Institution - 575

Poznan, 60-702, Poland

Location

Local Institution - 401

Poznan, 61-293, Poland

Location

Local Institution - 239

Sopot, 81756, Poland

Location

Local Institution - 235

Szczecin, 71434, Poland

Location

Local Institution - 822

Torun, 87-100, Poland

Location

Local Institution - 824

Tychy, 43-100, Poland

Location

Local Institution - 827

Ul. Piotrkowska 177, 90-447, Poland

Location

Local Institution - 410

Warsaw, 00-189, Poland

Location

Local Institution - 576

Warsaw, 01-192, Poland

Location

Local Institution - 825

Warsaw, 03-580, Poland

Location

Local Institution - 236

Warsaw, 04-501, Poland

Location

Local Institution - 808

Bucharest, 010719, Romania

Location

Local Institution - 836

Bucharest, 010719, Romania

Location

Local Institution - 499

Bucharest, 013823, Romania

Location

Local Institution - 795

Bucharest, 021494, Romania

Location

Local Institution - 837

Bucharest, 022328, Romania

Location

Local Institution - 839

Bucharest, 050098, Romania

Location

Local Institution - 842

Bucharest, 10825, Romania

Location

Local Institution - 838

Cluj-Napoca, 400001, Romania

Location

Local Institution - 843

Craiova, 200642, Romania

Location

Local Institution - 840

TĂ¢rgu MureÅŸ, 540136, Romania

Location

Local Institution - 598

Chita, 672090, Russia

Location

Local Institution - 848

Irkutsk, 664049, Russia

Location

Local Institution - 892

Kazan', 420103, Russia

Location

Local Institution - 599

Khanty-Mansiysk, 628012, Russia

Location

Local Institution - 927

Krasnoyarsk, 660037, Russia

Location

Local Institution - 851

Moscow, 111123, Russia

Location

Local Institution - 594

Novosibirsk, 630007, Russia

Location

Local Institution - 858

Petrozavodsk, 185019, Russia

Location

Local Institution - 859

Pushkin, 196603, Russia

Location

Local Institution - 960

Pyatigorsk, 357502, Russia

Location

Local Institution - 846

Pyatigorsk, 357538, Russia

Location

Local Institution - 883

Rostov-on-Don, 344022, Russia

Location

Local Institution - 862

Saint Petersburg, 194044, Russia

Location

Local Institution - 847

Saint Petersburg, 194354, Russia

Location

Local Institution - 857

Saint Petersburg, 195009, Russia

Location

Local Institution - 845

Saint Petersburg, 195067, Russia

Location

Local Institution - 856

Saint Petersburg, 195257, Russia

Location

Local Institution - 844

Samara, 443041, Russia

Location

Local Institution - 806

Tula, 300053, Russia

Location

Local Institution - 861

Ufa, 450071, Russia

Location

Local Institution - 855

Veliky Novgorod, 173008, Russia

Location

Local Institution - 935

Vladimir, 600023, Russia

Location

Local Institution - 999

Vladivostok, 690091, Russia

Location

Local Institution - 986

Vladivostok, 690922, Russia

Location

Local Institution - 534

Dammam, 32253, Saudi Arabia

Location

Local Institution - 537

Jeddah, 22252, Saudi Arabia

Location

Local Institution - 536

Riyadh, 12746, Saudi Arabia

Location

Local Institution - 535

Riyadh, 14611, Saudi Arabia

Location

Local Institution - 241

Belgrade, 11 000, Serbia

Location

Local Institution - 245

Belgrade, 11 080, Serbia

Location

Local Institution - 246

Belgrade, 11000, Serbia

Location

Local Institution - 437

Ansan, 152-703, South Korea

Location

Local Institution - 441

Busan, 49201, South Korea

Location

Local Institution - 435

Guri-si, 11923, South Korea

Location

Local Institution - 436

Seongnam-si, 13620, South Korea

Location

Local Institution - 433

Seoul, 06351, South Korea

Location

Local Institution - 440

Seoul, 06591, South Korea

Location

Local Institution - 430

Seoul, 120-752, South Korea

Location

Local Institution - 442

Seoul, 138-736, South Korea

Location

Local Institution - 427

Seoul, 3181, South Korea

Location

Local Institution - 439

Seoul, 7985, South Korea

Location

Local Institution - 703

Alicante, 03010, Spain

Location

Local Institution - 690

Badalona, 08916, Spain

Location

Local Institution - 691

Madrid, 28006, Spain

Location

Local Institution - 692

Madrid, 28046, Spain

Location

Local Institution - 698

San CristĂ³bal de La Laguna, 38320, Spain

Location

Local Institution - 696

Seville, 41009, Spain

Location

Local Institution - 705

Seville, 41013, Spain

Location

Local Institution - 700

Viladecans, 08840, Spain

Location

Local Institution - 967

Bern, 3001, Switzerland

Location

Local Institution - 968

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 969

Zurich, 8091, Switzerland

Location

Local Institution - 363

Kozlu, 67000, Taiwan

Location

Local Institution - 356

Ankara, 06590, Turkey (TĂ¼rkiye)

Location

Local Institution - 360

Bursa, 16059, Turkey (TĂ¼rkiye)

Location

Local Institution - 362

Istanbul, 34093, Turkey (TĂ¼rkiye)

Location

Local Institution - 355

Istanbul, 34840, Turkey (TĂ¼rkiye)

Location

Local Institution - 354

Izmit/Kocaeli, 41380, Turkey (TĂ¼rkiye)

Location

Local Institution - 359

Trabzon, 61080, Turkey (TĂ¼rkiye)

Location

Local Institution - 914

Chernivtsi, 58001, Ukraine

Location

Local Institution - 950

Dnipropetrovsk, 49074, Ukraine

Location

Local Institution - 229

Ivano-Frankivsk, 76008, Ukraine

Location

Local Institution - 912

Ivano-Frankivsk, 76018, Ukraine

Location

Local Institution - 919

Kharkiv, 61018, Ukraine

Location

Local Institution - 901

Kyiv, 01030, Ukraine

Location

Local Institution - 915

Kyiv, 02000, Ukraine

Location

Local Institution - 243

Kyiv, 02002, Ukraine

Location

Local Institution - 911

Kyiv, 02175, Ukraine

Location

Local Institution - 244

Kyiv, 03037, Ukraine

Location

Local Institution - 918

Kyiv, 04053, Ukraine

Location

Local Institution - 908

Kyiv, 04107, Ukraine

Location

Local Institution - 562

Kyiv, 4210, Ukraine

Location

Local Institution - 240

Lutsk, 43005, Ukraine

Location

Local Institution - 234

Lviv, 79010, Ukraine

Location

Local Institution - 910

Lviv, 79059, Ukraine

Location

Local Institution - 242

Odesa, 65025, Ukraine

Location

Local Institution - 905

Poltava, 36011, Ukraine

Location

Local Institution - 934

Ternopil, 46008, Ukraine

Location

Local Institution - 909

Vinnytsia, 02029, Ukraine

Location

Local Institution - 224

Vinnytsia, 21018, Ukraine

Location

Local Institution - 971

Vinnytsia, 21018, Ukraine

Location

Local Institution - 723

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 729

London, LND, NW1 2BU, United Kingdom

Location

Local Institution - 557

Birmingham, B15 2SQ, United Kingdom

Location

Local Institution - 714

Bristol, BS2 8HW, United Kingdom

Location

Local Institution - 560

Cardiff, CF15 9SS, United Kingdom

Location

Local Institution - 558

Chorley, PR7 7NA, United Kingdom

Location

Local Institution - 559

Corbridge Road, NE46 1QJ, United Kingdom

Location

Local Institution - 712

Dundonald, BT16 1RH, United Kingdom

Location

Local Institution - 713

Glasgow, G51 4TF, United Kingdom

Location

Local Institution - 716

Lancashire Blackpool, FY3 8NR, United Kingdom

Location

Local Institution - 722

London, E1 1BB, United Kingdom

Location

Local Institution - 715

London, SE1 9RT, United Kingdom

Location

Local Institution - 561

North Manchester Science Park, M15 6SX, United Kingdom

Location

Local Institution - 593

Shrewsbury, SY38XQ, United Kingdom

Location

Local Institution - 718

Torquay, TQ2 7AA, United Kingdom

Location

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.

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

ozanimod

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

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

February 27, 2018

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

November 4, 2025

Results First Posted

November 4, 2025

Record last verified: 2025-10

Locations