AzTrials
AzTrials

Crohn DiseasePhase 3NCT03440385

Induction Study #2 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 368 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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
606 participants
Where
368 sitesin 31 countries
Study dates
7 Mar 2018to 21 Nov 2023
Phase
Phase 3

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 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)

Who cannot join

  • 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
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

368 sites in 31 countries.

368 sites in 31 countries

United States81 sites

  • Local Institution - 037

    Atlanta, Georgia, 30322

  • Local Institution - 220

    Atlanta, Georgia, 30322

  • Local Institution - 020

    Baton Rouge, Louisiana, 70809

  • Local Institution - 182

    Bristol, Connecticut, 06010

  • Local Institution - 156

    Charlotte, North Carolina, 28209

  • Local Institution - 022

    Chicago, Illinois, 60637

  • Local Institution - 166

    Clearwater, Florida, 33765

  • Local Institution - 084

    Clermont, Florida, 34711

  • Local Institution - 065

    Colorado Springs, Colorado, 80907

  • American Research Institute Inc

    Cutler Bay, Florida, 33157

  • Local Institution - 170

    Dayton, Ohio, 45417

  • Local Institution - 143

    Decatur, Georgia, 30030

  • Local Institution - 112

    Doral, Florida, 33166

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Local Institution - 092

    Evansville, Indiana, 47714

  • Local Institution - 034

    Fort Sam Houston, Texas, 78234

  • Local Institution - 054

    Hartsdale, New York, 10530

  • Local Institution - 049

    Hilliard, Ohio, 43026

  • Local Institution - 079

    Houston, Texas, 77058

  • Local Institution - 196

    Houston, Texas, 77089

  • Gulf Coast Research Group LLC

    Houston, Texas, 77098

  • Local Institution - 115

    Idaho Falls, Idaho, 83404

  • Local Institution - 033

    Indianapolis, Indiana, 46202

  • Local Institution - 167

    Kalamazoo, Michigan, 49008

  • Local Institution - 198

    Kansas City, Missouri, 64111

  • SIH Research

    Kissimmee, Florida, 34759

  • Local Institution - 089

    La Crosse, Wisconsin, 54601

  • Ucsd Medical Center

    La Jolla, California, 92037

  • Clinical Trials of SW Louisiana LLC

    Lake Charles, Louisiana, 70601

  • Local Institution - 010

    Lancaster, California, 93534

  • Internal Medicine Specialists

    Las Vegas, Nevada, 89145

  • Local Institution - 040

    Lebanon, New Hampshire, 03756

  • Local Institution - 067

    Lighthouse PT, Florida, 33064

  • Southern California Research Institute Medical Group, Inc.

    Los Angeles, California, 90045

  • Matrix Clinical Research Inc

    Los Angeles, California, 90048

  • Local Institution - 030

    Lynchburg, Virginia, 24502

  • Center For Advanced Gastroenterology

    Maitland, Florida, 32751

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072

  • LMG Research

    Miami, Florida, 33125

  • Local Institution - 175

    Miami, Florida, 33166

  • Local Institution - 081

    Miami, Florida, 33176

  • Local Institution - 044

    Miami Springs, Florida, 33166

  • Paramount Medical Research & Consulting, Llc

    Middleburg Heights, Ohio, 44130

  • Local Institution - 095

    Minneapolis, Minnesota, 55455

  • Facey Medical Foundation (Parent)

    Mission Hills, California, 91345

  • Local Institution - 192

    New Port Richey, Florida, 34655

  • Weill Cornell Medical College

    New York, New York, 10010

  • Concorde Medical Group

    New York, New York, 10016

  • TrialSpark

    New York, New York, 10024

  • Local Institution - 087

    Norman, Oklahoma, 73071

  • Local Institution - 060

    North Massapequa, New York, 11758-1802

  • Local Institution - 005

    Novi, Michigan, 48377

  • Local Institution - 294

    Oklahoma City, Oklahoma, 73102

  • Local Institution - 200

    Orlando, Florida, 32810

  • Local Institution - 002

    Palmetto Bay, Florida, 33157

  • Local Institution - 093

    Pasadena, California, 91105

  • Accurate Clinical Research Inc

    Pasadena, Texas, 77505

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Theia Clinical Research, LLC

    Pinellas Park, Florida, 33781

  • The Gastroenterology Group

    Reston, Virginia, 20191

  • Local Institution - 071

    Richardson, Texas, 75082

  • Local Institution - 072

    Richmond, Virginia, 23249

  • Local Institution - 292

    Riverton, Utah, 84065

  • Local Institution - 172

    Roanoke, Virginia, 24016

  • Local Institution - 045

    Rochester, Minnesota, 55905

  • Sutter Medical Group

    Roseville, California, 95661

  • Local Institution - 280

    Sacramento, California, 95817

  • Local Institution - 178

    San Antonio, Texas, 78229

  • Local Institution - 281

    San Francisco, California, 94158

  • Local Institution - 202

    Scottsdale, Arizona, 85258

  • Precision Clinical Research, LLC.

    Sunrise, Florida, 33351

  • Local Institution - 183

    Tampa, Florida, 33612-4799

  • Apex Clinical Research

    Tampa, Florida, 33612

  • Local Institution - 107

    Tampa, Florida, 33614

  • Local Institution - 181

    Temple, Texas, 76508

  • Local Institution - 070

    Topeka, Kansas, 66606

  • Local Institution - 185

    Tulsa, Oklahoma, 74136

  • Local Institution - 217

    Tulsa, Oklahoma, 74137

  • Local Institution - 124

    West Covina, California, 91790

  • Local Institution - 052

    Winston-Salem, North Carolina, 27103

  • Local Institution - 024

    Worcester, Massachusetts, 01655

Other trials in United States

China35 sites

  • Local Institution - 482

    Beijing, 100050

  • Local Institution - 467

    Beijing, 100700

  • Local Institution - 379

    Bengbu, 233004

  • Local Institution - 485

    Changchun, 130021

  • Local Institution - 376

    Changchun, 130033

  • Local Institution - 421

    Changsha, 410008

  • Local Institution - 378

    Changsha, 450052

  • Local Institution - 423

    Changzhou, Jiangsu, 213003

  • Local Institution - 414

    Changzhou, 213004

  • Local Institution - 419

    Chengdu, 610041

  • Local Institution - 422

    Fuzhou, 350005

  • Local Institution - 478

    Guangzhou, 510030

  • Local Institution - 472

    Guangzhou, 510180

  • Local Institution - 486

    Guangzhou, 510655

  • Local Institution - 470

    Hangzhou, Zhejiang, 100142

  • Local Institution - 491

    Hefei, 230001

  • Local Institution - 374

    Kunming, 650032

  • Local Institution - 383

    Luzhou, 646099

  • Local Institution - 488

    Nanchang, 330006

  • Local Institution - 418

    Nanjing, 210008

  • Local Institution - 375

    Nanjing, 210009

  • Local Institution - 487

    Nanjing, 210029

  • Local Institution - 369

    Shanghai, Shanghai Municipality, 200120

  • Local Institution - 473

    Shanghai, 200025

  • Local Institution - 380

    Shanghai, 200040

  • Local Institution - 377

    Shanghai, 200080

  • Local Institution - 458

    Taichung City, 40447

  • Local Institution - 373

    Tianjin, 300052

  • Local Institution - 475

    Wuhan, 430022

  • Local Institution - 474

    Wuhan, 430030

  • Local Institution - 483

    Wuhan, 430060

  • Local Institution - 381

    Wuxi, 214023

  • Local Institution - 415

    Xi'an, 710038

  • Local Institution - 420

    Xi'an, 710100

  • Local Institution - 370

    Zhengzhou, 450014

Other trials in China

Russia34 sites

  • Local Institution - 966

    Barnaul, 656015

  • Local Institution - 871

    Barnaul, 656024

  • Local Institution - 589

    Bataysk, 346880

  • Local Institution - 621

    Chelyabinsk, 454021

  • Local Institution - 991

    Chelyabinsk, 454076

  • Local Institution - 998

    Kaliningrad, 236016

  • Local Institution - 882

    Kaluga, 248007

  • Local Institution - 849

    Kemerovo, 650066

  • Local Institution - 566

    Moscow, 105554

  • Local Institution - 995

    Moscow, 115516

  • Local Institution - 873

    Moscow, 117997

  • Local Institution - 870

    Moscow, 119192

  • Local Institution - 869

    Moscow, 123423

  • Local Institution - 990

    Nizhny Novgorod, 603140

  • Local Institution - 853

    Novosibirsk, 630091

  • Local Institution - 876

    Novosibirsk, 630117

  • Local Institution - 996

    Omsk, 644024

  • Local Institution - 875

    Orenburg, 460050

  • Local Institution - 867

    Penza, 440026

  • Local Institution - 863

    Saint Petersburg, 191015

  • Local Institution - 993

    Saint Petersburg, 191015

  • Local Institution - 868

    Saint Petersburg, 194044

  • Local Institution - 857

    Saint Petersburg, 195009

  • Local Institution - 879

    Saint Petersburg, 196143

  • Local Institution - 878

    Saint Petersburg, 196247

  • Local Institution - 874

    Saint Petersburg, 197110

  • Local Institution - 865

    Samara, 443001

  • Local Institution - 992

    Saratov, 410053

  • Local Institution - 866

    Sochi, 354207

  • Local Institution - 877

    Tomsk, 634063

  • Local Institution - 881

    Ufa, 450005

  • Local Institution - 880

    Volgograd, 400107

  • Local Institution - 583

    Yekaterinburg, 620075

  • Local Institution - 872

    Yekaterinburg, 620109

Other trials in Russia

Poland27 sites

  • Local Institution - 580

    Częstochowa, 42-202

  • Local Institution - 988

    Elblag, 82-300

  • Local Institution - 579

    Gdansk, 80-382

  • Local Institution - 978

    Gdansk, 80-803

  • Local Institution - 577

    Gdynia, 81-537

  • Local Institution - 906

    Jelenia Góra, 58-500

  • Local Institution - 757

    Józefów, 05-410

  • Local Institution - 578

    Katowice, 40-040

  • Local Institution - 834

    Ksawerów, 95-054

  • Local Institution - 581

    Lodz, 90-127

  • Local Institution - 981

    Lodz, 93-034

  • Local Institution - 976

    Nowy Targ, 34-400

  • Local Institution - 963

    Rzeszów, 35-302

  • Local Institution - 979

    Sopot, 81-756

  • Local Institution - 835

    Szczecin, 71-270

  • Local Institution - 586

    Warsaw, 00-728

  • Local Institution - 833

    Warsaw, 02-018

  • Local Institution - 989

    Warsaw, 02-653

  • Local Institution - 807

    Warsaw, 04-730

  • Local Institution - 893

    Wierzchosławice, 33-122

  • Local Institution - 983

    Wroclaw, 50-053

  • Local Institution - 984

    Wroclaw, 50-367

  • Local Institution - 582

    Wroclaw, 50-381

  • Local Institution - 982

    Wroclaw, 51-162

  • Local Institution - 831

    Wroclaw, 53-114

  • Local Institution - 987

    Wroclaw, 53-333

  • Local Institution - 832

    Wroclaw, 54-144

Other trials in Poland

Germany19 sites

  • Local Institution - 629

    Berlin, 10787

  • Local Institution - 653

    Berlin, 12200

  • Local Institution - 648

    Berlin, 13353

  • Local Institution - 628

    Berlin, 14163

  • Local Institution - 664

    Brandenburg an der Havel, 14770

  • Local Institution - 732

    Dachau, 85221

  • Local Institution - 574

    Frankfurt am Main, 60313

  • Local Institution - 657

    Frankfurt am Main, 60590

  • Local Institution - 658

    Halle, 06108

  • Local Institution - 656

    Halle, 06120

  • Local Institution - 652

    Hamburg, 22559

  • Local Institution - 591

    Hanover, 30625

  • Local Institution - 649

    Keil, 24105

  • Local Institution - 337

    Leipzig, 04103

  • Local Institution - 660

    Mainz, 55131

  • Local Institution - 667

    Münster, 48149

  • Local Institution - 620

    Neuruppin, 16816

  • Local Institution - 584

    Nürtingen, 72622

  • Local Institution - 661

    Stuttgart, 70376

Other trials in Germany

Ukraine16 sites

  • Local Institution - 922

    Chernivtsi, 58001

  • Local Institution - 929

    Ivano-Frankivsk, 76008

  • Local Institution - 965

    Kharkiv, 61037

  • Local Institution - 920

    Khmelnytskyi, 29000

  • Local Institution - 933

    Kropyvnytskyi, 25006

  • Local Institution - 923

    Kyiv, 01601

  • Local Institution - 563

    Kyiv, 02002

  • Local Institution - 564

    Kyiv, 03037

  • Local Institution - 977

    Kyiv, 04107

  • Local Institution - 590

    Lutsk, 43005

  • Local Institution - 974

    Lviv, 79010

  • Local Institution - 902

    Odesa, 65025

  • Local Institution - 932

    Vinnytsia, 21009

  • Local Institution - 924

    Vinnytsia, 21018

  • Local Institution - 587

    Zaporizhia, 69063

  • Local Institution - 925

    Zaporizhzhya, 69600

Other trials in Ukraine

Georgia15 sites

  • Local Institution - 786

    Batumi, 6010

  • Local Institution - 779

    Kutaisi, 4600

  • Local Institution - 454

    Tbilisi, 0101

  • Local Institution - 778

    Tbilisi, 0112

  • Local Institution - 782

    Tbilisi, 0131

  • Local Institution - 552

    Tbilisi, 0144

  • Local Institution - 793

    Tbilisi, 0159

  • Local Institution - 740

    Tbilisi, 0160

  • Local Institution - 783

    Tbilisi, 0160

  • Local Institution - 784

    Tbilisi, 0160

  • Local Institution - 785

    Tbilisi, 0160

  • Local Institution - 335

    Tbilisi, 0179

  • Local Institution - 455

    Tbilisi, 0180

  • Local Institution - 781

    Tbilisi, 0186

  • Local Institution - 780

    Telavi, 2200

Other trials in Georgia

Australia13 sites

  • Local Institution - 307

    Bedford Park, South Australia, 5042

  • Local Institution - 317

    Clayton, Victoria, 3168

  • Local Institution - 326

    Elizabeth Vale, South Australia, 05112

  • Local Institution - 305

    Fitzroy, Victoria, 3065

  • Local Institution - 329

    Geelong, Victoria, 3220

  • Local Institution - 328

    Herston, Queensland, 4029

  • Local Institution - 309

    Liverpool, New South Wales, 2170

  • Local Institution - 313

    Maroorchydore, Queensland, 4558

  • Local Institution - 327

    Melbourne, Victoria, 3004

  • Local Institution - 318

    New Lambton Heights, New South Wales, 2305

  • Local Institution - 321

    North Mackay, Queensland, 4740

  • Local Institution - 312

    South Brisbane, Queensland, 4101

  • Local Institution - 315

    Subiaco, Western Australia, 6008

Other trials in Australia

Hungary11 sites

  • Local Institution - 798

    Békéscsaba, 5600

  • Local Institution - 803

    Budapest, 1062

  • Local Institution - 804

    Budapest, 1088

  • Local Institution - 556

    Budapest, H-1036

  • Local Institution - 801

    Győr, 9024

  • Local Institution - 555

    Gyula, 5700

  • Local Institution - 797

    Miskolc, 3529

  • Local Institution - 800

    Nagykanizsa, H-8800

  • Local Institution - 799

    Székesfehérvár, 8000

  • Local Institution - 816

    Szekszárd, 7100

  • Local Institution - 805

    Szentes, 6600

Other trials in Hungary

Canada9 sites

  • Local Institution - 256

    Brandon, Manitoba, R7A 0N7

  • Local Institution - 269

    Edmonton, Alberta, T5R1W2

  • Local Institution - 266

    Greater Sudbury, Ontario, P3C 5K6

  • Local Institution - 254

    Montreal, Quebec, H1T 2M4

  • Local Institution - 262

    New Westminster, British Columbia, V3L 3W5

  • Local Institution - 270

    Ottawa, Quebec, K1H 8L6

  • Local Institution - 264

    Toronto, Ontario, M5G 1X5

  • Local Institution - 257

    Toronto, Ontario, M5T 3A9

  • Local Institution - 267

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Serbia9 sites

  • Local Institution - 887

    Belgrade, 11 080

  • Local Institution - 596

    Belgrade, 11000

  • Local Institution - 886

    Belgrade, 11000

  • Local Institution - 890

    Belgrade, 11000

  • Local Institution - 891

    Kragujevac, 34000

  • Local Institution - 884

    Novi Sad, 21 000

  • Local Institution - 885

    Pančevo, 26000

  • Local Institution - 585

    Vršac, 26300

  • Local Institution - 889

    Zrenjanin, 23 000

Other trials in Serbia

France8 sites

  • Local Institution - 639

    Béziers, 34525

  • Local Institution - 635

    Blois, 41016

  • Local Institution - 634

    Caen, 14000

  • Local Institution - 644

    Colombes, 92701

  • Local Institution - 632

    Nantes, 44093

  • Local Institution - 647

    Neuilly-sur-Seine, Cedex, 92200

  • Local Institution - 630

    Pierre-Bénite, 69495

  • Local Institution - 631

    Saint-Priest-en-Jarez, 42270

Other trials in France

Greece8 sites

  • Local Institution - 790

    Athens, 11 527

  • Local Institution - 588

    Athens, 115 28

  • Local Institution - 791

    Athens, 11527

  • Local Institution - 792

    Athens, 18536

  • Local Institution - 592

    Athens, Attiki, 15562

  • Local Institution - 787

    Heraklion, 71 110

  • Local Institution - 789

    Thessaloniki, 54642

  • Local Institution - 788

    Thessaloniki, 56429

Other trials in Greece

Spain8 sites

  • Teknon Medical Center

    Barcelona, 08022

  • University Hospital Reina Sofia

    Córdoba, 14001

  • University Hospital of Girona Dr. Josep Trueta

    Girona, 17007

  • Hospital Universitario De Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35012

  • Local Institution - 695

    Madrid, 28040

  • University Hospital Puerta de Hierro Majadajonda

    Majadahonda, Madrid, 28222

  • University Hospital Marques de Valdecilla (HUMV)

    Santander, 39008

  • Local Institution - 697

    Valencia, 46010

Other trials in Spain

Israel7 sites

  • Local Institution - 343

    Afula, 18341

  • Local Institution - 346

    Beer Jacob, 73100

  • Local Institution - 350

    Haifa, 3109601

  • Local Institution - 347

    Jerusalem, 9362410

  • Local Institution - 349

    Kfar Saba, 44281

  • Local Institution - 341

    Petah Tikva, 49100

  • Local Institution - 340

    Tel Aviv, 64239

Other trials in Israel

Slovakia7 sites

  • Local Institution - 900

    Bratislava, 820 07

  • Local Institution - 894

    Bratislava, 82606

  • Local Institution - 895

    Brezno, 97701

  • Local Institution - 899

    Nitra, 94901

  • Local Institution - 897

    Nové Zámky, 94002

  • Local Institution - 898

    Prešov, 080 01

  • Local Institution - 896

    Rimavská Sobota, 979 01

Other trials in Slovakia

South Africa7 sites

  • Local Institution - 543

    Gauteng, 1820

  • Local Institution - 545

    Kempton Park, 1619

  • Local Institution - 544

    Pretoria, 0001

  • Local Institution - 542

    Pretoria, 0084

  • Local Institution - 549

    Pretoria, 0181

  • Local Institution - 548

    Somerset West, 7130

  • Local Institution - 547

    Val de Grace, 0184

Other trials in South Africa

Taiwan7 sites

  • Local Institution - 460

    Kaohsiung City, 82445

  • Local Institution - 463

    Kaohsiung, San Ming Dist., 807

  • Local Institution - 461

    Niao-Sung Hsiang Kaohsiung County, 83301

  • Local Institution - 459

    Tainan, Taiana, 704

  • Local Institution - 462

    Taoyuan City, 33305

  • Local Institution - 465

    Tapei, 10002

  • Local Institution - 464

    Tapei, Beitou Dist., 11217

Other trials in Taiwan

Bulgaria6 sites

  • Local Institution - 753

    Rousse, 7002

  • Local Institution - 750

    Sofia, 1407

  • Local Institution - 755

    Sofia, 1407

  • Local Institution - 756

    Sofia, 1431

  • Local Institution - 752

    Sofia, 1527

  • Local Institution - 554

    Sofia, 1784

Other trials in Bulgaria

Netherlands6 sites

  • Local Institution - 952

    Amsterdam, 1081 HV

  • Local Institution - 955

    Amsterdam, 1105 AZ

  • Local Institution - 956

    Groningen, 9713 GZ

  • Local Institution - 949

    Nijmegen, 6525 GA

  • Local Institution - 951

    Sittard-Geleen, 6162 BG

  • Local Institution - 954

    Tilburg, 5022 GC

Other trials in Netherlands

Colombia5 sites

  • Local Institution - 397

    Armenia, 630004

  • Local Institution - 398

    Barranquilla, 080020

  • Local Institution - 395

    Bogotá, 110221

  • Local Institution - 396

    Cali, 760026

  • Local Institution - 394

    Medellín, 050034

Other trials in Colombia

Lithuania5 sites

  • Local Institution - 605

    Kaunas, LT-50009

  • Local Institution - 603

    Klaipėda, LT-5808

  • Local Institution - 607

    Vilnius, 08406

  • Local Institution - 606

    Vilnius, LT-08661

  • Local Institution - 604

    Vilnius, LT-10207

Other trials in Lithuania

South Korea5 sites

  • Local Institution - 434

    Busan, 49241

  • Local Institution - 431

    Busan, 612-030

  • Local Institution - 432

    Daegu, 705-030

  • Local Institution - 438

    Seoul, 3080

  • Local Institution - 429

    Suwon, 442723

Other trials in South Korea

Turkey (Türkiye)5 sites

  • Local Institution - 357

    Ankara, 01660

  • Local Institution - 365

    Elâzığ, 23119

  • Local Institution - 358

    Istanbul, 34098

  • Local Institution - 361

    Istanbul, 34668

  • Local Institution - 353

    Kadiköy/Istanbul, 41380

Other trials in Turkey (Türkiye)

Austria4 sites

  • Local Institution - 726

    Innsbruck, 6020

  • Local Institution - 727

    Sankt Pölten, 3100

  • Local Institution - 336

    Vienna, 1020

  • Local Institution - 725

    Vienna, 1090

Other trials in Austria

Portugal4 sites

  • Local Institution - 959

    Coimbra, 3000-075

  • Local Institution - 958

    Guimarães, 4835-044

  • Local Institution - 961

    Loures, 2674-514

  • Local Institution - 957

    Viana do Castelo, 4904-858

Other trials in Portugal

Finland2 sites

  • Local Institution - 613

    Helsinki, 00290

  • Local Institution - 614

    Turku, FI-20521

Other trials in Finland

Hong Kong2 sites

  • Local Institution - 404

    Hong Kong, 0

  • Local Institution - 405

    Kowloon, 0

Other trials in Hong Kong

Senegal1 site

  • Local Institution - 546

    Cape Town, 7500

Other trials in Senegal

Slovenia1 site

  • Local Institution - 904

    Celje, 3000

Other trials in Slovenia

Sweden1 site

  • Local Institution - 625

    Stockholm, 112 81

Other trials in Sweden

About this study

Official title: 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

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, RPC01-3202
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 NCT03440385
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. 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.

    Measured: Week 12

Secondary outcomes (12)

  1. Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission

    Abdominal pain and stool frequency clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 with abdominal pain and stool frequency no worse than baseline at Week 12. Participants entered the responses in diaries daily. The 7 days entries prior to Week 12 visit were considered for calculating average abdominal pain score and stool frequency. The abdominal pain was graded on severity of 0 (none) to 3 (severe) scale and stool frequency was defined number of liquid or soft stools per day. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.

    Measured: Week 12

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

    The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.

    Measured: Week 12

  3. 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

    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. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.

    Measured: Week 12

  4. 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%

    CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers 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 visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.

    Measured: Week 12

  5. 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%

    CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers 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 visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.

    Measured: Week 12

  6. Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points

    Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.

    Measured: Week 12

  7. Percentage of Participants With Global Histologic Activity Score (GHAS) Remission

    GHAS assesses the inflammation and mucosal damage. GHAS has 8 components Epithelial damage, Architectural changes, Infiltration of mononuclear cells in the lamina propria, Infiltration of polymorphonuclear cells in the lamina propria, Polymorphonuclear cells in epithelium, Presence of erosion and/or ulcers, Presence of granuloma and number of biopsy specimens affected. Each of these components was scored on a scale of 0 (none/unaffected) to 2 (worst). Each of these 8 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. Within each segment, the GHAS score has a range of 0 - 16, and the total GHAS score has a range of 0 - 80. Higher numbers correspond to more inflammation and more mucosal damage. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.

    Measured: Week 12

  8. Percentage of Participants With CDAI Reduction From Baseline of >=70 Points

    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. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.

    Measured: Week 12

  9. Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%

    The ulcerated surface were assessed via endoscopy.

    Measured: Week 12

  10. Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%

    CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. The CDEIS divides the intestine into 5 segments: rectum, sigmoid and left colon, transverse colon, right colon, and ileum. Four variables are assessed in each segment: the presence of deep ulceration, the presence of superficial ulceration, the percentage of ulcerated surface, and the percentage of surface affected by CD, indicated on 10-cm visual analogue scales. In addition, the presence of ulcerated stenosis and the presence of nonulcerated stenosis are also assessed over the entire intestine. These factors are weighted and summed to calculate the total score ranging from 0- 44, with higher scores indicating more severe disease.

    Measured: Week 12

  11. Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response

    AP and SF clinical remission is average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). Endoscopic Response is defined as >= 50% decrease from baseline in SES-CD. In SES-CD, each of 4 components are assessed in five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was sum of individual scores of each of components across five segments. Range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.

    Measured: Week 12

  12. Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12

    RHI mucosal healing was defined as RHI remission combined with SES-CD <= 4 points and a SES-CD decrease from baseline >= 2 points with no SES-CD sub-score >1 point. RHI Remission is defined as no active inflammation in any measured segment. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation.

    Measured: 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 start7 Mar 2018
  3. Primary completion21 Nov 2023
  4. Study completion21 Nov 2023

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
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03440385
Sponsor's protocol ID
RPC01-3202
Other IDs
U1111-1203-7949, 2017-004293-33, 2017
Status last verified
Nov 2024
First submitted
14 Feb 2018
Last updated
5 Dec 2024
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

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