AzTrials
AzTrials

Crohn DiseasePhase 3NCT03440372

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

A Phase 3 study testing Ozanimod in people with Crohn Disease, run by Celgene at 408 sites in 35 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. 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
625 participants
Where
408 sitesin 35 countries
Study dates
27 Feb 2018to 1 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

  • 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)

Who cannot join

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

Trial locations and contacts

408 sites in 35 countries.

408 sites in 35 countries

United States107 sites

  • Local Institution - 017

    Asheville, North Carolina, 28801

  • Local Institution - 205

    Atlanta, Georgia, 30308

  • 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 - 210

    Beachwood, Ohio, 44122

  • 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 - 142

    Chestnut Hill, Massachusetts, 02467

  • Local Institution - 194

    Chicago, Illinois, 60612

  • Local Institution - 036

    Chicago, Illinois, 60622

  • Local Institution - 165

    Chula Vista, California, 91911

  • Local Institution - 291

    Cincinnati, Ohio, 45219

  • Local Institution - 062

    Clearwater, Florida, 33756-3839

  • Local Institution - 018

    Cleveland, Ohio, 44195

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Local Institution - 074

    Columbus, Georgia, 31904

  • Local Institution - 215

    Englewood, New Jersey, 07631

  • 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 - 197

    Hershey, Pennsylvania, 17033

  • Local Institution - 203

    Hialeah, Florida, 33010

  • Harmony Medical Research Institute

    Hialeah, Florida, 33016

  • Local Institution - 078

    Hialeah, Florida, 33016

  • Local Institution - 179

    Hollywood, Florida, 33021

  • Local Institution - 101

    Homestead, Florida, 33033

  • CroNOLA LLC

    Houma, Louisiana, 70360

  • Local Institution - 056

    Houston, Texas, 77030

  • Local Institution - 150

    Houston, Texas, 77030

  • Local Institution - 102

    Houston, Texas, 77043

  • Local Institution - 082

    Houston, Texas, 77070

  • Local Institution - 303

    Houston, Texas, 77074

  • Local Institution - 088

    Houston, Texas, 77084

  • Local Institution - 274

    Jackson, Mississippi, 39216

  • San Diego Clinical Trials

    La Mesa, California, 91942

  • Local Institution - 053

    Lake Charles, Louisiana, 70601

  • Local Institution - 297

    Lakewood, Colorado, 80228

  • Local Institution - 016

    Largo, Florida, 33777

  • Local Institution - 155

    Lexington, Kentucky, 40536-0298

  • Local Institution - 061

    Los Angeles, California, 90027

  • Local Institution - 110

    Los Angeles, California, 90067

  • Local Institution - 028

    Macon, Georgia, 31201

  • Local Institution - 298

    Manassas, Virginia, 20110

  • Local Institution - 177

    Mentor, Ohio, 44060

  • Local Institution - 199

    Miami, Florida, 33125

  • LCC Medical Research Institute, LLC

    Miami, Florida, 33126

  • Local Institution - 169

    Miami, Florida, 33156

  • Local Institution - 140

    Mission Viejo, California, 92691

  • Local Institution - 090

    Naples, Florida, 34109

  • Local Institution - 121

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Local Institution - 091

    New Haven, Connecticut, 06510

  • Local Institution - 104

    New Orleans, Louisiana, 70125

  • Local Institution - 214

    New Smyrna Beach, Florida, 32168

  • Local Institution - 105

    New York, New York, 10021

  • Local Institution - 043

    New York, New York, 10075

  • Local Institution - 026

    North Little Rock, Arkansas, 72117

  • Local Institution - 228

    North Worcester, Massachusetts, 01655

  • Alliance Clinical Research

    Oceanside, California, 92056

  • Local Institution - 208

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 131

    Oklahoma City, Oklahoma, 73112

  • Local Institution - 027

    Orange, California, 92868

  • Local Institution - 094

    Orchard Park, New York, 14127

  • Local Institution - 076

    Orlando, Florida, 32819

  • Palo Alto Center-Palo Alto Medical Foundation Research Institute

    Palo Alto, California, 94304

  • Holland Center for Family Health

    Peoria, Arizona, 85381

  • Local Institution - 139

    Petersburg, Virginia, 23805

  • 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

  • Local Institution - 006

    Rialto, California, 92377

  • Local Institution - 025

    Salt Lake City, Utah, 84132

  • Local Institution - 085

    San Antonio, Texas, 78215

  • Local Institution - 223

    San Antonio, Texas, 78229

  • Local Institution - 003

    San Diego, California, 92123

  • 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

  • Local Institution - 226

    Tampa, Florida, 33612

  • Local Institution - 149

    Tampa, Florida, 33614

  • Advantage Clinical Trials

    The Bronx, New York, 10468

  • Local Institution - 073

    Tyler, Texas, 75701

  • Advanced Gastroenterology

    Union City, Tennessee, 38261

  • Local Institution - 146

    Urbana, Illinois, 61801

  • Local Institution - 211

    Warren, Ohio, 44483

  • Local Institution - 114

    Weeki Wachee, Florida, 34607

  • Local Institution - 296

    Williamsburg, Virginia, 23188

  • Local Institution - 301

    Wyoming, Michigan, 49519

  • Local Institution - 300

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland29 sites

  • Local Institution - 820

    Bialystok, 15-276

  • Local Institution - 818

    Bochnia, 32-700

  • Local Institution - 238

    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 - 829

    Lodz, 90-302

  • Local Institution - 888

    Lodz, 91-839

  • Local Institution - 760

    Lublin, 20-049

  • 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 - 239

    Sopot, 81756

  • 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 - 825

    Warsaw, 03-580

  • Local Institution - 236

    Warsaw, 04-501

  • Local Institution - 403

    Zamość, Lublin Voivodeship, 22-400

  • Local Institution - 597

    Zamość, Lublin Voivodeship, 22-400

Other trials in Poland

Russia24 sites

  • Local Institution - 598

    Chita, 672090

  • Local Institution - 848

    Irkutsk, 664049

  • Local Institution - 892

    Kazan', 420103

  • Local Institution - 599

    Khanty-Mansiysk, 628012

  • Local Institution - 927

    Krasnoyarsk, 660037

  • Local Institution - 851

    Moscow, 111123

  • Local Institution - 594

    Novosibirsk, 630007

  • Local Institution - 858

    Petrozavodsk, 185019

  • Local Institution - 859

    Pushkin, 196603

  • Local Institution - 960

    Pyatigorsk, 357502

  • Local Institution - 846

    Pyatigorsk, 357538

  • Local Institution - 883

    Rostov-on-Don, 344022

  • Local Institution - 862

    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 - 844

    Samara, 443041

  • Local Institution - 806

    Tula, 300053

  • 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

Other trials in Russia

Ukraine22 sites

  • Local Institution - 914

    Chernivtsi, 58001

  • Local Institution - 950

    Dnipropetrovsk, 49074

  • Local Institution - 229

    Ivano-Frankivsk, 76008

  • Local Institution - 912

    Ivano-Frankivsk, 76018

  • Local Institution - 919

    Kharkiv, 61018

  • Local Institution - 901

    Kyiv, 01030

  • Local Institution - 915

    Kyiv, 02000

  • Local Institution - 243

    Kyiv, 02002

  • Local Institution - 911

    Kyiv, 02175

  • Local Institution - 244

    Kyiv, 03037

  • Local Institution - 918

    Kyiv, 04053

  • Local Institution - 908

    Kyiv, 04107

  • Local Institution - 562

    Kyiv, 4210

  • Local Institution - 240

    Lutsk, 43005

  • Local Institution - 234

    Lviv, 79010

  • Local Institution - 910

    Lviv, 79059

  • Local Institution - 242

    Odesa, 65025

  • Local Institution - 905

    Poltava, 36011

  • Local Institution - 934

    Ternopil, 46008

  • Local Institution - 909

    Vinnytsia, 02029

  • Local Institution - 224

    Vinnytsia, 21018

  • Local Institution - 971

    Vinnytsia, 21018

Other trials in Ukraine

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

Other trials in Italy

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

Other trials in United Kingdom

Australia13 sites

  • Local Institution - 308

    Adelaide, South Australia, 5000

  • Local Institution - 708

    Adelaide, South Australia, 5112

  • Local Institution - 325

    Bankstown, 2200

  • Local Institution - 330

    Box Hill, 3128

  • Local Institution - 310

    Concord, New South Wales, 2139

  • Local Institution - 319

    Kingswood, New South Wales, 2747

  • Local Institution - 707

    Maroochydore, Queensland, 4558

  • Local Institution - 709

    Melbourne, Victoria, 3004

  • Local Institution - 316

    Murdoch, Western Australia, 6150

  • 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

Other trials in Australia

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

Other trials in Czechia

Germany12 sites

  • Local Institution - 626

    Berlin, 10117

  • Local Institution - 665

    Berlin, 10825

  • Local Institution - 650

    Berlin, 14050

  • Local Institution - 662

    Frankfurt, 60431

  • Local Institution - 654

    Frankfurt, 60594

  • Local Institution - 659

    Hamburg, 20246

  • Local Institution - 651

    Leipzig, 04103

  • Local Institution - 655

    Ludwigshafen am Rhein, 67067

  • Local Institution - 730

    Ludwigshafen am Rhein, 67067

  • Local Institution - 661

    Stuttgart, 70376

  • Local Institution - 666

    Tübingen, 72076

  • Local Institution - 663

    Ulm, 89081

Other trials in Germany

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

Other trials in Argentina

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

Other trials in India

Canada10 sites

  • Local Institution - 268

    Bridgewater, Nova Scotia, B4V 3N2

  • Local Institution - 273

    Calgary, Alberta, T2N 4Z6

  • Local Institution - 227

    Edmonton, Alberta, T5R 1W2

  • Local Institution - 263

    Kelowna, British Columbia, V1Y 1Z9

  • Local Institution - 252

    London, Ontario, N6A 5A5

  • Local Institution - 251

    London, Ontario, N6A 5W9

  • Local Institution - 275

    Toronto, Ontario, M5G 1X8

  • Local Institution - 255

    Vancouver, British Columbia, V5Z1M9

  • Local Institution - 271

    Vaughan, Ontario, L4L 4Y7

  • Local Institution - 261

    Winnipeg, Manitoba, R3CON2

Other trials in Canada

France10 sites

  • Local Institution - 638

    Amiens, 80054

  • 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 - 641

    Rennes, 35033

  • Local Institution - 612

    Rouen, 76031

  • Local Institution - 643

    Toulouse, 31059

Other trials in France

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

Other trials in Mexico

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

Other trials in Romania

South Korea10 sites

  • Local Institution - 437

    Ansan, 152-703

  • Local Institution - 441

    Busan, 49201

  • 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 - 427

    Seoul, 3181

  • Local Institution - 439

    Seoul, 7985

Other trials in South Korea

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

Other trials in Belgium

Bulgaria8 sites

  • Local Institution - 456

    Blagoevgrad, 2700

  • Local Institution - 746

    Plovdiv, 4002

  • Local Institution - 747

    Sofia, 1202

  • Local Institution - 627

    Sofia, 1527

  • Local Institution - 749

    Sofia, 1606

  • Local Institution - 748

    Sofia, 1784

  • Local Institution - 553

    Stara Zagora, 6000

  • Local Institution - 754

    Varna, 9002

Other trials in Bulgaria

Croatia8 sites

  • Local Institution - 453

    Koprivnica, 48000

  • Local Institution - 763

    Osijek, 31000

  • Local Institution - 764

    Rijeka, 51000

  • Local Institution - 765

    Split, HR-21000

  • Local Institution - 452

    Zagreb, 10000

  • Local Institution - 761

    Zagreb, 10000

  • Local Institution - 762

    Zagreb, 10000

  • Local Institution - 766

    Zagreb, 10000

Other trials in Croatia

Spain8 sites

  • Local Institution - 703

    Alicante, 03010

  • Local Institution - 690

    Badalona, 08916

  • Local Institution - 691

    Madrid, 28006

  • Local Institution - 692

    Madrid, 28046

  • Local Institution - 698

    San Cristóbal de La Laguna, 38320

  • Local Institution - 696

    Seville, 41009

  • Local Institution - 705

    Seville, 41013

  • Local Institution - 700

    Viladecans, 08840

Other trials in Spain

Turkey (Türkiye)6 sites

  • Local Institution - 356

    Ankara, 06590

  • Local Institution - 360

    Bursa, 16059

  • Local Institution - 362

    Istanbul, 34093

  • Local Institution - 355

    Istanbul, 34840

  • Local Institution - 354

    Izmit/Kocaeli, 41380

  • Local Institution - 359

    Trabzon, 61080

Other trials in Turkey (Türkiye)

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

Other trials in Chile

Israel5 sites

  • Local Institution - 345

    Bat Yam, 5962025

  • Local Institution - 339

    Jerusalem, 91031

  • Local Institution - 344

    Nahariya, 22100

  • Local Institution - 342

    Ramat Gan, 52621

  • Local Institution - 338

    Rehovot, 76100

Other trials in Israel

Moldova5 sites

  • Local Institution - 811

    Chisinau, MD-2068

  • Local Institution - 810

    Chisinau, MD2005

  • Local Institution - 809

    Chisinau, MD2025

  • Local Institution - 812

    Chisinau, MD2025

  • Local Institution - 813

    Chisinau, MD2025

Other trials in Moldova

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

Other trials in Bosnia and Herzegovina

Saudi Arabia4 sites

  • Local Institution - 534

    Dammam, 32253

  • Local Institution - 537

    Jeddah, 22252

  • Local Institution - 536

    Riyadh, 12746

  • Local Institution - 535

    Riyadh, 14611

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Denmark3 sites

  • Local Institution - 611

    Copenhagen, 2400

  • Local Institution - 610

    Holbæk, 4300

  • Local Institution - 609

    Nykøbing Falster, 4800

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Georgia3 sites

  • Local Institution - 248

    Tbilisi, 0101

  • Local Institution - 247

    Tbilisi, 0112

  • Local Institution - 249

    Tbilisi, 0180

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Latvia3 sites

  • Local Institution - 602

    Riga, LV-1002

  • Local Institution - 601

    Riga, LV-1006

  • Local Institution - 600

    Riga, LV-1038

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Serbia3 sites

  • Local Institution - 241

    Belgrade, 11 000

  • Local Institution - 245

    Belgrade, 11 080

  • Local Institution - 246

    Belgrade, 11000

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Switzerland3 sites

  • Local Institution - 967

    Bern, 3001

  • Local Institution - 968

    Sankt Gallen, 9007

  • Local Institution - 969

    Zurich, 8091

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Belarus2 sites

  • Local Institution - 745

    Grodno, 230026

  • Local Institution - 737

    Vitebsk, 210604

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Ireland2 sites

  • Local Institution - 975

    Dublin, Dublin, DO4 T6F4

  • Local Institution - 973

    Dublin, D09 V2N0

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Finland1 site

  • Local Institution - 614

    Turku, FI-20521

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Taiwan1 site

  • Local Institution - 363

    Kozlu, 67000

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About this study

Official title: Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Conditions
Crohn Disease
Being tested
Ozanimod, Placebo
Keywords
Crohn's Disease, Crohn Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3201
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 groups in NCT03440372
Study groupRoleWhat they receive
Administration of oral OzanimodExperimentalNot described
Receives: Drug: Ozanimod
Administration of PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 12

Secondary outcomes (11)

  1. 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

    Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as an average daily abdominal pain score ≤1 and average daily stool frequency ≤3, with AP and SF no worse than baseline at Week 12. AP was graded on a scale from 0 (none) to 3 (severe), and SF was defined as the number of liquid or soft stools per day. This measure reports the percentage of participants who, by Week 12, had low abdominal pain (score ≤1) and three or fewer bowel movements per day, without worsening symptoms compared to when they started the study. Participants began using the diary at the first visit and continued throughout the study.

    Measured: At Week 12

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

    The Simple Endoscopic Score for Crohn's Disease (SES-CD) is used to assess the degree of inflammation in patients with Crohn's disease. The SES-CD evaluates four components-size of ulcers, ulcerated surface, affected surface, and presence of narrowing-each scored from 0 (none) to 3 (severe): score ranges from 0-12 across four components and 0-60 overall across five segments (ileum, right colon, transverse colon, left colon, rectum). The total higher SES-CD score indicating greater inflammation. Baseline is defined as the last assessment prior to the first drug administration (based on the time of measurement, if available; otherwise, the last assessment prior to or on the date of first drug administration). This measure reports the percentage of participants whose SES-CD score improved by 50% or more from baseline to Week 12.

    Measured: At Week 12

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

    The Crohn's Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn's disease. CDAI is calculated using 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over the 7 days prior to each visit. The remaining variables are also weighted and included in the total CDAI score, which ranges from 0-600, with higher scores indicating worse disease activity (score 150-219 = mild, 220-450 = moderate, >450 = severe). This measure reports the percentage of participants whose CDAI score improved by at least 100 points, or was below 150, at 12 weeks.

    Measured: At Week 12

  4. 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

    The Crohn's Disease Activity Index (CDAI) is a composite score used to measure clinical activity in Crohn's disease. CDAI is based on 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over 7 days prior to each visit. The total CDAI score ranges from 0-600, with higher scores indicating worse disease activity (score 150-219 = mild, 220-450 = moderate, >450 = severe). This measure reports the percentage of participants whose Crohn's disease improved at 12 weeks, defined as a CDAI decrease of at least 100 points or a score below 150, along with at least a 50% reduction in intestinal inflammation (SES-CD score).

    Measured: At Week 12

  5. 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

    This endpoint measured the percentage of participants who achieved both clinical remission and significant endoscopic improvement at Week 12. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than 150 at Week 12. Endoscopic improvement was defined as a decrease of at least 50% from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The CDAI was a composite score assessing disease activity based on symptoms and laboratory values, while the SES-CD evaluated endoscopic findings in the intestinal mucosa. Achieving both criteria indicated substantial improvement in both symptoms and intestinal inflammation.

    Measured: At Week 12

  6. Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12

    This measure reports the percentage of participants whose Crohn's disease symptoms and gut inflammation improved at 12 weeks. It includes those with mild or no belly pain (score ≤1), no more than three bowel movements per day (score ≤3), and no worsening from baseline. It also includes participants whose gut inflammation, measured by SES-CD, was low (score ≤4) and improved by at least 2 points. SES-CD assesses inflammation based on four components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing, each scored from 0 (none) to 3 (severe) across five segments (ileum, right colon, transverse colon, left colon, rectum). The total SES-CD score ranges from 0-12 per segment and 0-60 overall, with higher scores indicating greater inflammation.

    Measured: At Week 12

  7. Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency Score no Worse Than Baseline and an SES-CD Decrease From Baseline of ≥ 50% at Week 12

    This measure reports the percentage of participants whose Crohn's disease symptoms and gut inflammation improved at 12 weeks. It includes those with mild or no belly pain (score ≤1), no more than three bowel movements per day (score ≤3), and no worsening from baseline. It also includes participants whose gut inflammation, measured by SES-CD, improved by at least 50% from baseline. SES-CD assesses inflammation based on four components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing, each scored from 0 (none) to 3 (severe): score ranges from 0-12 across four components and 0-60 overall across five segments (ileum, right colon, transverse colon, left colon, rectum). The total higher SES-CD score indicating greater inflammation.

    Measured: At Week 12

  8. Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12

    This measure evaluated improvement in gut inflammation at 12 wks using Global Histologic Activity Score (GHAS). GHAS was assessed for each ileal \& colonic segment (ileum, right colon, transverse colon, left colon-descending/sigmoid colon \& rectum). Segment subscores were calculated by adding scores for epithelial damage/tissue changes(0-2), cellular infiltration for mononuclear \& polymorphonuclear cells(0-2 each), presence of certain cells(0-3) \& erosion, ulcers, granulomas(0 or 1). GHAS score within each segment ranged from 0-16 \& across five segments ranged from 0-80. Higher scores indicated more inflammation. Responders with histologic remission was defined as GHAS score ≤8 (each segment) [meeting criteria: epithelial damage(0), architectural changes(0-2), mononuclear cell infiltration(0-2), polymorphonuclear cell infiltration(0), polymorphonuclear cells in epithelium(0), erosion/ulcers(0), granuloma(0-1) \& affected biopsy specimens(0-3)] \& ≤40 (across all segments).

    Measured: At Week 12

  9. Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12

    This measure reports the percentage of participants whose Crohn's disease symptoms improved meaningfully after 12 weeks of treatment, defined as a decrease of at least 70 points in their Crohn's Disease Activity Index (CDAI) score from baseline. The CDAI is a composite score used to assess clinical activity in Crohn's disease, based on 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over 7 days prior to each visit. The total CDAI score ranges from 0-600, with higher scores indicating more severe disease (score 150-219 = mild, 220-450 = moderate, >450 = severe).

    Measured: At Week 12

  10. Percent of Participants With Absence of Ulcers ≥ 0.5 cm With No Segment With Any Ulcerated Surface ≥ 10% at Week 12

    This measure shows the percentage of participants have no longer any large ulcers (bigger than 0.5 cm) in their gut and in any section of the gut, less than 10% of the surface has ulcers at 12 weeks. This helps to understand how well the treatment is healing the gut and reducing ulceration.

    Measured: At Week 12

  11. Percent of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% at Week 12

    CDEIS is an index used to determine Crohn's disease severity by endoscopic exam of the ileum and colon. The intestine is divided into 5 segments: rectum, sigmoid/left colon, transverse colon, right colon, and ileum. In each segment, four variables are assessed: deep ulceration, superficial ulceration, percentage of ulcerated surface, and percentage of surface affected by Crohn's disease, using 10-cm visual analogue scales. The presence of ulcerated and nonulcerated stenosis is also evaluated across the entire intestine. These factors are weighted and summed for a total score from 0-44, with higher scores indicating more severe disease. This measure reports the percentage of participants whose CDEIS score improved by at least 50% at 12 weeks, based on endoscopic exam.

    Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start27 Feb 2018
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Why it stopped: Business objectives have changed.

Resources

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
625 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03440372
Sponsor's protocol ID
RPC01-3201
Other IDs
U1111-1203-7225, 2017-004292-31, 2017
Status last verified
Oct 2025
First submitted
14 Feb 2018
Last updated
4 Nov 2025
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

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 408 sites in 35 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 5 inclusion and 4 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 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 408 sites in United States, Poland, Russia, Ukraine, Italy and 30 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 4 Nov 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?

Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 (time frame: At Week 12). 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 NCT03440372, 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 4 Nov 2025.

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