Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03440372 |
Recruitment Status :
Recruiting
First Posted : February 22, 2018
Last Update Posted : February 21, 2023
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn Disease | Drug: Ozanimod Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 27, 2018 |
Estimated Primary Completion Date : | March 22, 2024 |
Estimated Study Completion Date : | June 28, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Administration of oral Ozanimod |
Drug: Ozanimod
Specified dose on specified days |
Placebo Comparator: Administration of Placebo |
Other: Placebo
Specified dose on specified days |
- Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150 [ Time Frame: Week 12 ]
- Proportion 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 [ Time Frame: Week 12 ]
- Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
- Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [ Time Frame: Week 12 ]
- Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
- Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
- Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points [ Time Frame: Week 12 ]
- Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
- Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes) [ Time Frame: Week 12 ]
- Proportion of participants with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 12 ]
- Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Week 12 ]
- Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440372
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
Contact: First line of the email MUST contain the NCT# and Site #. |


United States, Arizona | |
Holland Center for Family Health | Completed |
Peoria, Arizona, United States, 85381 | |
United States, Arkansas | |
Arkansas Gastroenterology, P.A. | Recruiting |
North Little Rock, Arkansas, United States, 72117 | |
Contact: Scott Wofford, Site 026 | |
United States, California | |
Sharp Chula Vista Medical Center | Completed |
Chula Vista, California, United States, 91911 | |
Valley View Internal Medicine | Recruiting |
Garden Grove, California, United States, 92843 | |
Contact: Michael Kurtz, Site 039 855-229-1665 | |
San Diego Clinical Trials | Completed |
La Mesa, California, United States, 91942 | |
Children's Hospital Of Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Sarah Sheibani, Site 061 | |
GastroIntestinal Biosciences | Recruiting |
Los Angeles, California, United States, 90067 | |
Contact: Nicholas Karyotakis, Site 110 310-766-2079 | |
Local Institution - 209 | Withdrawn |
Mather, California, United States, 95655 | |
ABS Health, LLC | Completed |
Mission Viejo, California, United States, 92691 | |
Alliance Clinical Research | Completed |
Oceanside, California, United States, 92056 | |
Palo Alto Center-Palo Alto Medical Foundation Research Institute | Completed |
Palo Alto, California, United States, 94304 | |
Inland Empire Liver Foundation | Recruiting |
Rialto, California, United States, 92377 | |
Contact: Zeid Kayali, Site 006 909-883-2999 | |
Medical Associates Research Group | Recruiting |
San Diego, California, United States, 92123 | |
Contact: Hyun Kim, Site 003 858-277-5678 | |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06510 | |
Contact: Deborah Proctor, Site 091 203-785-4138 | |
United States, Florida | |
Gastro Florida | Recruiting |
Clearwater, Florida, United States, 33756-3839 | |
Contact: Michael Weiss, Site 062 239-275-8882 | |
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza | Recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Angela Pham, Site 218 | |
Qway Research LLC | Recruiting |
Hialeah, Florida, United States, 33010 | |
Contact: Miguel Chamah, Site 203 | |
Floridian Clinical Research LLC | Completed |
Hialeah, Florida, United States, 33016 | |
Harmony Medical Research Institute | Completed |
Hialeah, Florida, United States, 33016 | |
The Center for Gastrointestinal Disorders | Recruiting |
Hollywood, Florida, United States, 33021 | |
Contact: Mark Lamet, Site 179 954-961-7771 | |
Vista Health Research | Completed |
Homestead, Florida, United States, 33033 | |
Florida Center for Gastroenterology | Recruiting |
Largo, Florida, United States, 33777 | |
Contact: Steven Beljic, Site 016 727-544-2555 | |
Nova Clinical Research Center LLC | Recruiting |
Miami, Florida, United States, 33125 | |
Contact: Amado Viera, Site 199 786-534-8856 | |
LCC Medical Research Institute, LLC | Completed |
Miami, Florida, United States, 33126 | |
Research Associates of South Florida LLC | Recruiting |
Miami, Florida, United States, 33156 | |
Contact: Javier Sobrado, Site 169 305-270-0402 | |
Advanced Research for Health Improvement | Completed |
Naples, Florida, United States, 34109 | |
NSB Research | Recruiting |
New Smyrna Beach, Florida, United States, 32168 | |
Contact: Bryan Heath, Site 214 386-672-1985 | |
HMD Research LLC | Recruiting |
Orlando, Florida, United States, 32819 | |
Contact: Marvin Heuer, Site 076 | |
Advanced Medical Research Center | Recruiting |
Port Orange, Florida, United States, 32127 | |
Contact: Ammar Hemaidan, Site 098 | |
Asclepes Research Centers | Completed |
Weeki Wachee, Florida, United States, 34607 | |
United States, Georgia | |
Consultative Gastroenterology | Completed |
Atlanta, Georgia, United States, 30308 | |
Atlanta Gastroenterology Associates, Llc | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Douglas Wolf, Site 019 404-257-9000 | |
Children's Center for Digestive Healthcare | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Jeffery Lewis, Site 063 | |
Local Institution - 074 | Completed |
Columbus, Georgia, United States, 31904 | |
Gastroenterology Associates Of Central Georgia LLC | Recruiting |
Macon, Georgia, United States, 31201 | |
Contact: Shahriar Sedghi, Site 028 | |
United States, Illinois | |
Rush University Medical Center - University Cardiovascular Surgeons | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Garth Swanson, Site 194 | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60622 | |
Contact: Stephen Hanauer, Site 036 312-695-8952 | |
Carle Foundation Hospital | Completed |
Urbana, Illinois, United States, 61801 | |
United States, Iowa | |
Iowa Digestive Disease Center | Completed |
Clive, Iowa, United States, 50325 | |
United States, Kentucky | |
University of Kentucky Health Care | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Deborah Flomenhoft, Site 155 859-323-1086 | |
United States, Louisiana | |
CroNOLA LLC | Completed |
Houma, Louisiana, United States, 70360 | |
Centex Studies, Inc. | Completed |
Lake Charles, Louisiana, United States, 70601 | |
Nola Research Works | Completed |
New Orleans, Louisiana, United States, 70125 | |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Alyssa Parian, Site 278 | |
Local Institution - 129 | Completed |
Catonsville, Maryland, United States, 21228 | |
Woodholme Gastroenterology Associates | Recruiting |
Glen Burnie, Maryland, United States, 21061 | |
Contact: Kenolisa Onwueme, Site 282 | |
United States, Massachusetts | |
Brigham and Women's Hospital - Crohn's and Colitis Center | Recruiting |
Chestnut Hill, Massachusetts, United States, 02467 | |
Contact: Jessica Allegretti, Site 142 305-338-3662 | |
Local Institution - 286 | Completed |
Springfield, Massachusetts, United States, 01199 | |
United States, Michigan | |
Medex Research Institute | Recruiting |
Caro, Michigan, United States, 48723 | |
Contact: Naveed Mahfooz, Site 191 517-673-4126 | |
Revive Research Institute | Recruiting |
Southfield, Michigan, United States, 48034 | |
Contact: Alan Cutler, Site 108 | |
United States, Mississippi | |
Southern Therapy and Advanced Research | Recruiting |
Jackson, Mississippi, United States, 39216 | |
Contact: Brian Borg, Site 274 601-984-4548 | |
United States, Missouri | |
Washington University School Of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Parakkal Deepak, Site 029 847-316-4000 | |
United States, New Jersey | |
Englewood Hospital and Medical Center | Completed |
Englewood, New Jersey, United States, 07631 | |
United States, New York | |
Advantage Clinical Trials | Completed |
Bronx, New York, United States, 10468 | |
NY Scientific | Recruiting |
Brooklyn, New York, United States, 11235 | |
Contact: Igor Grosman, Site 144 347-547-6972 | |
Northwell Health | Recruiting |
Great Neck, New York, United States, 11021 | |
Contact: Keith Sultan, Site 009 516-562-4281 | |
Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Randy Longman, Site 105 | |
Lenox Hill Hospital | Recruiting |
New York, New York, United States, 10075 | |
Contact: Arun Swaminath, Site 043 | |
Circuit Clinical | Completed |
Orchard Park, New York, United States, 14127 | |
United States, North Carolina | |
Local Institution - 017 | Completed |
Asheville, North Carolina, United States, 28801 | |
Carolinas HealthCare System Digestive Health | Recruiting |
Charlotte, North Carolina, United States, 28204 | |
Contact: John Hanson, Site 152 | |
Local Institution - 055 | Completed |
Charlotte, North Carolina, United States, 28207 | |
Carolina Research Center | Recruiting |
Greenville, North Carolina, United States, 27834 | |
Contact: Phillip Goldstein, Site 133 252-758-8182 | |
United States, Ohio | |
Great Lakes Medical Research, LLC | Completed |
Beachwood, Ohio, United States, 44122 | |
Ohio GI and Liver Institute | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Matthew Atkinson, Site 291 513-872-4549 | |
Local Institution - 018 | Completed |
Cleveland, Ohio, United States, 44195 | |
Great Lakes Gastroenterology | Completed |
Mentor, Ohio, United States, 44060 | |
Great Lakes Medical Research, LLC | Completed |
Warren, Ohio, United States, 44483 | |
United States, Oklahoma | |
University Of Oklahoma Health Sciences Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Richard Harty, Site 208 | |
Digestive Disease Specialists | Recruiting |
Oklahoma City, Oklahoma, United States, 73112 | |
Contact: David Stokesberry, Site 131 405-942-6620 | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Nir Modiano, Site 113 | |
United States, Pennsylvania | |
Penn State Milton S Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Kofi Clarke, Site 197 717-531-0630 | |
Penn State University Milton S Hershey Medical Center | Completed |
State College, Pennsylvania, United States, 16803 | |
United States, South Carolina | |
Medical University Of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Erin Forster, Site 289 843-792-6982 | |
United States, Tennessee | |
Local Institution - 121 | Completed |
Nashville, Tennessee, United States, 37211 | |
Vanderbilt University Medical Center | Completed |
Nashville, Tennessee, United States, 37212 | |
Advanced Gastroenterology | Completed |
Union City, Tennessee, United States, 38261 | |
United States, Texas | |
Avant Research Associates, LLC - Austin | Recruiting |
Austin, Texas, United States, 78742 | |
Contact: Rajesh Mehta, Site 158 | |
Houston Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Bincy Abraham, Site 056 713-441-0006 | |
Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jason Hou, Site 150 713-798-0951 | |
Biopharma Informatic Inc. Research Center | Completed |
Houston, Texas, United States, 77043 | |
Local Institution - 082 | Completed |
Houston, Texas, United States, 77070 | |
Local Institution - 088 | Completed |
Houston, Texas, United States, 77084 | |
Sun Research Institute | Recruiting |
San Antonio, Texas, United States, 78215 | |
Contact: Carl Dukes, Site 085 210-227-1289 | |
Texas Digestive Disease Consultants - Southlake | Recruiting |
Southlake, Texas, United States, 76092 | |
Contact: Timothy Ritter, Site 007 817-424-1525 | |
Digestive Health Specialists of Tyler | Recruiting |
Tyler, Texas, United States, 75701 | |
Contact: George Du Vall, Site 073 903-595-5101 | |
United States, Utah | |
University Of Utah School Of Medicine | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Jessica Johnson, Site 025 | |
United States, Virginia | |
Local Institution - 189 | Completed |
Gainesville, Virginia, United States, 20155 | |
Local Institution - 139 | Completed |
Petersburg, Virginia, United States, 23805 | |
Virginia Gastroenterology Institute PC | Completed |
Suffolk, Virginia, United States, 23434 | |
United States, Washington | |
University Of Washington Medical Center | Not yet recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Scott Lee, Site 012 206-685-8684 | |
Dermatologist Specialists of Spokane | Recruiting |
Spokane, Washington, United States, 99204 | |
Contact: Gary Gleason, Site 125 | |
United States, Wisconsin | |
Aurora Health Care Aurora Research | Completed |
Grafton, Wisconsin, United States, 53024 | |
Argentina | |
Local Institution - 501 | Recruiting |
Buenos Aires, Argentina, 0 | |
Contact: Site 501 | |
Local Institution - 571 | Recruiting |
Buenos Aires, Argentina, 1702 | |
Contact: Site 571 | |
Local Institution - 500 | Recruiting |
Buenos Aires, Argentina, B1878 | |
Contact: Site 500 | |
Local Institution - 568 | Not yet recruiting |
Buenos Aires, Argentina, C1264 | |
Contact: Site 568 | |
Local Institution - 494 | Completed |
Ciudad Autonoma de Buenos Aires, Argentina, 1180 | |
Local Institution - 570 | Recruiting |
Cordoba, Argentina, X5003DCE | |
Contact: Site 570 | |
Local Institution - 495 | Recruiting |
Cordoba, Argentina, X5016 | |
Contact: Site 495 | |
Local Institution - 569 | Recruiting |
Mar del Plata, Argentina, B7600 | |
Contact: Site 569 | |
Local Institution - 502 | Recruiting |
Rosario, Santa Fe, Argentina, S2002 | |
Contact: Site 502 | |
Local Institution - 496 | Completed |
Rosario, Argentina, 2000 | |
Local Institution - 497 | Recruiting |
Rosario, Argentina, 2000 | |
Contact: Site 497 | |
Local Institution - 492 | Recruiting |
San Miguel de Tucuman, Argentina, 4000 | |
Contact: Site 492 | |
Australia, New South Wales | |
Local Institution - 310 | Recruiting |
Concord, New South Wales, Australia, 2139 | |
Contact: Site 310 | |
Local Institution - 319 | Recruiting |
Kingswood, New South Wales, Australia, 2747 | |
Contact: Site 319 | |
Local Institution - 323 | Recruiting |
Wollongong, New South Wales, Australia, 2500 | |
Contact: Site 323 | |
Australia, Queensland | |
Local Institution - 311 | Recruiting |
Woolloongabba, Queensland, Australia, 4102 | |
Contact: Site 311 | |
Australia, South Australia | |
Local Institution - 308 | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Site 308 | |
Local Institution - 320 | Recruiting |
Woodville South, South Australia, Australia, 5011 | |
Contact: Site 320 | |
Australia, Western Australia | |
Local Institution - 316 | Completed |
Murdoch, Western Australia, Australia, 6150 | |
Australia | |
Local Institution - 325 | Not yet recruiting |
Bankstown, Australia, 2200 | |
Contact: Site 325 | |
Local Institution - 330 | Recruiting |
Box Hill, Australia, 3128 | |
Contact: Site 330 | |
Local Institution - 324 | Not yet recruiting |
Sydney, NSW, Australia, NSW 2050 | |
Contact: Site 324 | |
Belarus | |
Local Institution - 745 | Recruiting |
Grodno, Belarus, 230026 | |
Contact: Site 745 | |
Local Institution - 737 | Recruiting |
Vitebsk, Belarus, 210604 | |
Contact: Site 737 | |
Belgium | |
Local Institution - 943 | Completed |
Brasschaat, Antwerpen, Belgium, 2930 | |
Local Institution - 940 | Recruiting |
Brussels, Belgium, 1090 | |
Contact: Site 940 | |
Local Institution - 939 | Recruiting |
Edegem, Belgium, 2650 | |
Contact: Site 939 | |
Local Institution - 937 | Completed |
Ghent, Belgium, 9000 | |
Local Institution - 942 | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Site 942 | |
Local Institution - 936 | Recruiting |
Liege, Belgium, 4000 | |
Contact: Site 936 | |
Local Institution - 938 | Recruiting |
Seraing, Belgium, 4100 | |
Contact: Site 938 | |
Local Institution - 941 | Completed |
Tournai, Belgium, 7500 | |
Bosnia and Herzegovina | |
Local Institution - 743 | Recruiting |
Banja Luka, Bosnia and Herzegovina, 78000 | |
Contact: Site 743 | |
Local Institution - 741 | Completed |
Mostar, Bosnia and Herzegovina, 88000 | |
Local Institution - 738 | Completed |
Sarajevo, Bosnia and Herzegovina, 71000 | |
Local Institution - 742 | Completed |
Sarajevo, Bosnia and Herzegovina, 71000 | |
Bulgaria | |
Local Institution - 746 | Recruiting |
Plovdiv, Bulgaria, 4002 | |
Contact: Site 746 | |
Local Institution - 747 | Completed |
Sofia, Bulgaria, 1202 | |
Local Institution - 749 | Completed |
Sofia, Bulgaria, 1606 | |
Local Institution - 748 | Recruiting |
Sofia, Bulgaria, 1784 | |
Contact: Site 748 | |
Local Institution - 553 | Completed |
Stara Zagora, Bulgaria, 6000 | |
Local Institution - 754 | Completed |
Varna, Bulgaria, 9002 | |
Canada, Alberta | |
Local Institution - 273 | Recruiting |
Calgary, Alberta, Canada, T2N 4Z6 | |
Contact: Site 273 | |
Canada, British Columbia | |
Local Institution - 263 | Completed |
Kelowna, British Columbia, Canada, V1Y 1Z9 | |
Local Institution - 255 | Completed |
Vancouver, British Columbia, Canada, V5Z1M9 | |
Canada, Manitoba | |
Local Institution - 261 | Completed |
Winnipeg, Manitoba, Canada, R3CON2 | |
Canada, Nova Scotia | |
Local Institution - 268 | Completed |
Bridgewater, Nova Scotia, Canada, B4V 3N2 | |
Canada, Ontario | |
Local Institution - 252 | Recruiting |
London, Ontario, Canada, N6A 5A5 | |
Contact: Site 252 | |
Local Institution - 251 | Recruiting |
London, Ontario, Canada, N6A 5W9 | |
Contact: Site 251 | |
Local Institution - 271 | Recruiting |
Vaughan, Ontario, Canada, L4L 4Y7 | |
Contact: Site 271 | |
Chile | |
Local Institution - 389 | Not yet recruiting |
Concepción, Chile, 4070038 | |
Contact: Site 389 | |
Local Institution - 387 | Recruiting |
Santiago, Chile, 7500571 | |
Contact: Site 387 | |
Local Institution - 390 | Recruiting |
Santiago, Chile, 8320000 | |
Contact: Site 390 | |
Croatia | |
Local Institution - 763 | Completed |
Osijek, Croatia, 31000 | |
Local Institution - 764 | Completed |
Rijeka, Croatia, 51000 | |
Local Institution - 765 | Recruiting |
Split, Croatia, HR-21000 | |
Contact: Site 765 | |
Local Institution - 761 | Completed |
Zagreb, Croatia, 10000 | |
Local Institution - 762 | Completed |
Zagreb, Croatia, 10000 | |
Local Institution - 766 | Recruiting |
Zagreb, Croatia, 10000 | |
Contact: Site 766 | |
Czechia | |
Local Institution - 767 | Recruiting |
Brno, Czechia, 615 00 | |
Contact: Site 767 | |
Local Institution - 772 | Recruiting |
Brno, Czechia, 656 91 | |
Contact: Site 772 | |
Local Institution - 773 | Recruiting |
Hradec Králové, Czechia, 500 12 | |
Contact: Site 773 | |
Local Institution - 775 | Recruiting |
Most, Czechia, 43401 | |
Contact: Site 775 | |
Local Institution - 771 | Recruiting |
Olomouc, Czechia, 77900 | |
Contact: Site 771 | |
Local Institution - 774 | Recruiting |
Pardubice, Czechia, 532 03 | |
Contact: Site 774 | |
Local Institution - 769 | Completed |
Plzen, Czechia, 30460 | |
Local Institution - 768 | Completed |
Prague 5, Czechia, 150 06 | |
Local Institution - 770 | Recruiting |
Prague 9, Czechia, 190 00 | |
Contact: Site 770 | |
Local Institution - 573 | Recruiting |
Prague, Czechia, 120 00 | |
Contact: Site 573 | |
Local Institution - 776 | Recruiting |
Praha 4, Czechia, 14021 | |
Contact: Site 776 | |
Denmark | |
Local Institution - 611 | Completed |
Copenhagen, Denmark, 2400 | |
Local Institution - 610 | Completed |
Holbaek, Denmark, 4300 | |
Local Institution - 609 | Completed |
Nykobing F, Denmark, 4800 | |
Finland | |
Local Institution - 614 | Completed |
Turku, Finland, FI-20521 | |
France | |
Local Institution - 638 | Recruiting |
Amiens cedex 1, France, 80054 | |
Contact: Site 638 | |
Local Institution - 711 | Recruiting |
Creteil Cedex, France, 94010 | |
Contact: Site 711 | |
Local Institution - 616 | Recruiting |
Dijon Cedex, France, 21079 | |
Contact: Site 616 | |
Local Institution - 615 | Recruiting |
Grenoble Cedex 9, France, 38700 | |
Contact: Site 615 | |
Local Institution - 633 | Recruiting |
Lillie Cedex, France, 59037 | |
Contact: Site 633 | |
Local Institution - 646 | Recruiting |
Marseille cedex 20, France, 13915 | |
Contact: Site 646 | |
Local Institution - 641 | Recruiting |
Rennes, France, 35033 | |
Contact: Site 641 | |
Local Institution - 612 | Recruiting |
Rouen Cedex, France, 76031 | |
Contact: Site 612 | |
Local Institution - 643 | Completed |
Toulouse Cedex 09, France, 31059 | |
Germany | |
Local Institution - 626 | Recruiting |
Berlin, Germany, 10117 | |
Contact: Site 626 | |
Local Institution - 665 | Completed |
Berlin, Germany, 10825 | |
Local Institution - 650 | Recruiting |
Berlin, Germany, 14050 | |
Contact: Site 650 | |
Local Institution - 662 | Recruiting |
Frankfurt, Germany, 60431 | |
Contact: Site 662 | |
Local Institution - 654 | Completed |
Frankfurt, Germany, 60594 | |
Local Institution - 659 | Recruiting |
Hamburg, Germany, 20246 | |
Contact: Site 659 | |
Local Institution - 337 | Not yet recruiting |
Leipzig, Germany, 04103 | |
Contact: Site 337 | |
Local Institution - 651 | Recruiting |
Leipzig, Germany, 04103 | |
Contact: Site 651 | |
Local Institution - 655 | Recruiting |
Ludwigshafen am Rhein, Germany, 67067 | |
Contact: Site 655 | |
Local Institution - 730 | Recruiting |
Ludwigshafen am Rhein, Germany, 67067 | |
Contact: Site 730 | |
Local Institution - 661 | Completed |
Stuttgart, Germany, 70376 | |
Local Institution - 666 | Recruiting |
Tuebingen, Germany, 72076 | |
Contact: Site 666 | |
Local Institution - 663 | Recruiting |
Ulm, Germany, 89081 | |
Contact: Site 663 | |
Ireland | |
Local Institution - 975 | Recruiting |
Dublin 4, Dublin, Ireland, DO4 T6F4 | |
Contact: Site 975 | |
Local Institution - 973 | Recruiting |
Dublin 9, Ireland, D09 V2N0 | |
Contact: Site 973 | |
Israel | |
Local Institution - 345 | Completed |
Bat Yam, Israel, 5962025 | |
Local Institution - 339 | Recruiting |
Jerusalem, Israel, 91031 | |
Contact: Site 339 | |
Local Institution - 344 | Completed |
Nahariya, Israel, 22100 | |
Local Institution - 342 | Recruiting |
Ramat Gan, Israel, 52621 | |
Contact: Site 342 | |
Local Institution - 338 | Recruiting |
Rechovot, Israel, 76100 | |
Contact: Site 338 | |
Italy | |
Local Institution - 677 | Active, not recruiting |
Bologna, Italy, 40138 | |
Local Institution - 684 | Recruiting |
Brescia, Italy, 25123 | |
Contact: Site 684 | |
Local Institution - 688 | Recruiting |
Brescia, Italy, 25124 | |
Contact: Site 688 | |
Local Institution - 689 | Recruiting |
Castellana Grotte, Italy, 70013 | |
Contact: Site 689 | |
Local Institution - 679 | Recruiting |
Catanzaro, Italy, 88100 | |
Contact: Site 679 | |
Local Institution - 687 | Recruiting |
Chieti, Italy, 66100 | |
Contact: Site 687 | |
Local Institution - 674 | Recruiting |
Messina, Italy, 98125 | |
Contact: Site 674 | |
Local Institution - 686 | Completed |
Milano, Italy, 20122 | |
Local Institution - 334 | Recruiting |
Milano, Italy, 20132 | |
Contact: Site 334 | |
Local Institution - 672 | Recruiting |
Milan, Italy, 20089 | |
Contact: Site 672 | |
Local Institution - 678 | Recruiting |
Monza, Italy, 20900 | |
Contact: Site 678 | |
Local Institution - 685 | Recruiting |
Padova, Italy, 35128 | |
Contact: Site 685 | |
Local Institution - 682 | Recruiting |
Palermo, Italy, 90146 | |
Contact: Site 682 | |
Local Institution - 673 | Recruiting |
Pavia, Italy, 27100 | |
Contact: Site 673 | |
Local Institution - 681 | Completed |
Roma, Italy, 00133 | |
Local Institution - 675 | Recruiting |
Roma, Italy, 00168 | |
Contact: Site 675 | |
Local Institution - 671 | Recruiting |
Rome, Italy, 00152 | |
Contact: Site 671 | |
Local Institution - 680 | Recruiting |
Udine, Italy, 33100 | |
Contact: Site 680 | |
Local Institution - 670 | Completed |
Varese, Italy, 21100 | |
Local Institution - 676 | Recruiting |
Verona, Italy, 37024 | |
Contact: Site 676 | |
Korea, Republic of | |
Local Institution - 437 | Completed |
Ansan, Korea, Republic of, 152-703 | |
Local Institution - 441 | Recruiting |
Busan, Korea, Republic of, 49201 | |
Contact: Site 441 | |
Local Institution - 435 | Recruiting |
Guri-si, Korea, Republic of, 11923 | |
Contact: Site 435 | |
Local Institution - 436 | Completed |
Seongnam-si, Korea, Republic of, 13620 | |
Local Institution - 433 | Recruiting |
Seoul, Korea, Republic of, 06351 | |
Contact: Site 433 | |
Local Institution - 440 | Recruiting |
Seoul, Korea, Republic of, 06591 | |
Contact: Site 440 | |
Local Institution - 430 | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Contact: Site 430 | |
Local Institution - 442 | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact: Site 442 | |
Local Institution - 427 | Recruiting |
Seoul, Korea, Republic of, 3181 | |
Contact: Site 427 | |
Local Institution - 439 | Recruiting |
Seoul, Korea, Republic of, 7985 | |
Contact: Site 439 | |
Latvia | |
Local Institution - 602 | Recruiting |
Riga, Latvia, LV-1002 | |
Contact: Site 602 | |
Local Institution - 601 | Recruiting |
Riga, Latvia, LV-1006 | |
Contact: Site 601 | |
Local Institution - 600 | Completed |
Riga, Latvia, LV-1038 | |
Mexico | |
Local Institution - 526 | Recruiting |
Zapapan, Jalisco, Mexico, 45030 | |
Contact: Site 526 | |
Local Institution - 532 | Recruiting |
Monterrey, Nuevo León, Mexico, 64610 | |
Contact: Site 532 | |
Local Institution - 525 | Completed |
Monterrey, Nuevo León, Mexico, 64718 | |
Local Institution - 447 | Recruiting |
Monterrey, Nuevo León, Mexico, C.P 64000 | |
Contact: Site 447 | |
Local Institution - 449 | Recruiting |
Monterrey, Nuevo León, Mexico, C.P 64060 | |
Contact: Site 449 | |
Local Institution - 529 | Recruiting |
Santiago de Queretaro, Querétaro, Mexico, 76070 | |
Contact: Site 529 | |
Local Institution - 528 | Completed |
Chihuahua, Mexico, 31020 | |
Local Institution - 448 | Recruiting |
Mexico City, Mexico, 6700 | |
Contact: Site 448 | |
Local Institution - 527 | Recruiting |
Mexico, Mexico, 07020 | |
Contact: Site 527 | |
Local Institution - 530 | Recruiting |
Tlalpan, Mexico, 14080 | |
Contact: Site 530 | |
Moldova, Republic of | |
Local Institution - 811 | Recruiting |
Chisinau, Moldova, Republic of, MD-2068 | |
Contact: Site 811 | |
Local Institution - 810 | Completed |
Chisinau, Moldova, Republic of, MD2005 | |
Local Institution - 809 | Recruiting |
Chisinau, Moldova, Republic of, MD2025 | |
Contact: Site 809 | |
Local Institution - 812 | Recruiting |
Chisinau, Moldova, Republic of, MD2025 | |
Contact: Site 812 | |
Local Institution - 813 | Recruiting |
Chisinau, Moldova, Republic of, MD2025 | |
Contact: Site 813 | |
Poland | |
Local Institution - 820 | Recruiting |
Bialystok, Poland, 15-276 | |
Contact: Site 820 | |
Local Institution - 818 | Recruiting |
Bochnia, Poland, 32-700 | |
Contact: Site 818 | |
Local Institution - 828 | Completed |
Katowice, Poland, 40-660 | |
Local Institution - 819 | Recruiting |
Katowice, Poland, 40-752 | |
Contact: Site 819 | |
Local Institution - 817 | Recruiting |
Klodzko, Poland, 57-300 | |
Contact: Site 817 | |
Local Institution - 815 | Completed |
Krakow, Poland, 30-363 | |
Local Institution - 823 | Recruiting |
Krakow, Poland, 31-156 | |
Contact: Site 823 | |
Local Institution - 826 | Recruiting |
Krakow, Poland, 31-501 | |
Contact: Site 826 | |
Local Institution - 829 | Recruiting |
Lodz, Poland, 90-302 | |
Contact: Site 829 | |
Local Institution - 888 | Completed |
Lodz, Poland, 91-839 | |
Local Institution - 760 | Recruiting |
Lublin, Poland, 20-049 | |
Contact: Site 760 | |
Local Institution - 830 | Recruiting |
Olsztyn, Poland, 10-561 | |
Contact: Site 830 | |
Local Institution - 758 | Recruiting |
Poznan, Poland, 60-529 | |
Contact: Site 758 | |
Local Institution - 575 | Recruiting |
Poznan, Poland, 60-702 | |
Contact: Site 575 | |
Local Institution - 822 | Completed |
Torun, Poland, 87-100 | |
Local Institution - 824 | Recruiting |
Tychy, Poland, 43-100 | |
Contact: Site 824 | |
Local Institution - 827 | Recruiting |
Ul. Piotrkowska 177, Poland, 90-447 | |
Contact: Site 827 | |
Local Institution - 410 | Recruiting |
Warsaw, Poland, 00-632 | |
Contact: Site 410 | |
Local Institution - 576 | Recruiting |
Warszawa, Poland, 01-192 | |
Contact: Site 576 | |
Local Institution - 825 | Completed |
Warszawa, Poland, 03-580 | |
Romania | |
Local Institution - 808 | Completed |
Bucharest, Romania, 010719 | |
Local Institution - 836 | Completed |
Bucharest, Romania, 010719 | |
Local Institution - 499 | Recruiting |
Bucharest, Romania, 013823 | |
Contact: Site 499 | |
Local Institution - 795 | Recruiting |
Bucharest, Romania, 021494 | |
Contact: Site 795 | |
Local Institution - 837 | Recruiting |
Bucharest, Romania, 022328 | |
Contact: Site 837 | |
Local Institution - 839 | Completed |
Bucharest, Romania, 050098 | |
Local Institution - 842 | Recruiting |
Bucharest, Romania, 10825 | |
Contact: Site 842 | |
Local Institution - 843 | Completed |
Craiova, Romania, 200642 | |
Local Institution - 838 | Recruiting |
Napoca, Romania, 400001 | |
Contact: Site 838 | |
Local Institution - 840 | Completed |
Targu Mures, Romania, 540136 | |
Russian Federation | |
Local Institution - 598 | Terminated |
Chita, Russian Federation, 672090 | |
Local Institution - 848 | Completed |
Irkutsk, Russian Federation, 664049 | |
Local Institution - 892 | Terminated |
Kazan, Russian Federation, 420103 | |
Local Institution - 599 | Completed |
Khanty-mansiysk, Russian Federation, 628012 | |
Local Institution - 927 | Completed |
Krasnoyarsk, Russian Federation, 660037 | |
Local Institution - 851 | Completed |
Moscow, Russian Federation, 111123 | |
Local Institution - 594 | Completed |
Novosibirsk, Russian Federation, 630007 | |
Local Institution - 858 | Completed |
Petrozavodsk, Russian Federation, 185019 | |
Local Institution - 859 | Completed |
Pushkin, Russian Federation, 196603 | |
Local Institution - 960 | Completed |
Pyatigorsk, Russian Federation, 357502 | |
Local Institution - 846 | Completed |
Pyatigorsk, Russian Federation, 357538 | |
Local Institution - 883 | Completed |
Rostov-on-Don, Russian Federation, 344022 | |
Local Institution - 847 | Completed |
Saint Petersburg, Russian Federation, 194354 | |
Local Institution - 844 | Completed |
Samara, Russian Federation, 443041 | |
Local Institution - 862 | Completed |
St Petersburg, Russian Federation, 194044 | |
Local Institution - 857 | Completed |
St. Petersburg, Russian Federation, 195009 | |
Local Institution - 845 | Completed |
St. Petersburg, Russian Federation, 195067 | |
Local Institution - 856 | Terminated |
St. Petersburg, Russian Federation, 195257 | |
Local Institution - 948 | Not yet recruiting |
Surgut, Russian Federation, 628408 | |
Contact: Site 948 | |
Local Institution - 806 | Terminated |
Tula, Russian Federation, 300053 | |
Local Institution - 861 | Completed |
Ufa, Russian Federation, 450071 | |
Local Institution - 642 | Not yet recruiting |
Ulyanovsk, Russian Federation, 432017 | |
Contact: Site 642 | |
Local Institution - 855 | Completed |
Veliky Novgorod, Russian Federation, 173008 | |
Local Institution - 935 | Completed |
Vladimir, Russian Federation, 600023 | |
Local Institution - 999 | Completed |
Vladivostok, Russian Federation, 690091 | |
Local Institution - 986 | Completed |
Vladivostok, Russian Federation, 690922 | |
Saudi Arabia | |
Local Institution - 534 | Completed |
Dammam, Saudi Arabia, 32253 | |
Local Institution - 537 | Recruiting |
Jeddah, Saudi Arabia, 22252 | |
Contact: Site 537 | |
Local Institution - 536 | Recruiting |
Riyadh, Saudi Arabia, 12746 | |
Contact: Site 536 | |
Local Institution - 535 | Recruiting |
Riyadh, Saudi Arabia, 14611 | |
Contact: Site 535 | |
Spain | |
Local Institution - 703 | Recruiting |
Alicante, Spain, 03010 | |
Contact: Site 703 | |
Local Institution - 690 | Recruiting |
Badalona, Spain, 08916 | |
Contact: Site 690 | |
Local Institution - 698 | Recruiting |
La Laguna, Spain, 38320 | |
Contact: Site 698 | |
Local Institution - 691 | Recruiting |
Madrid, Spain, 28006 | |
Contact: Site 691 | |
Local Institution - 692 | Recruiting |
Madrid, Spain, 28046 | |
Contact: Site 692 | |
Local Institution - 696 | Completed |
Sevilla, Spain, 41009 | |
Local Institution - 705 | Completed |
Sevilla, Spain, 41013 | |
Local Institution - 700 | Completed |
Viladecans, Spain, 08840 | |
Switzerland | |
Local Institution - 967 | Recruiting |
Bern, Switzerland, 3001 | |
Contact: Site 967 | |
Local Institution - 968 | Recruiting |
St.Gallen, Switzerland, 9007 | |
Contact: Site 968 | |
Local Institution - 969 | Completed |
Zurich, Switzerland, 8091 | |
Taiwan | |
Local Institution - 363 | Recruiting |
Kozlu, Taiwan, 67000 | |
Contact: Site 363 | |
Turkey | |
Local Institution - 356 | Completed |
Ankara, Turkey, 06590 | |
Local Institution - 360 | Completed |
Bursa, Turkey, 16059 | |
Local Institution - 362 | Recruiting |
Istanbul, Turkey, 34093 | |
Contact: Site 362 | |
Local Institution - 355 | Completed |
Istanbul, Turkey, 34840 | |
Local Institution - 354 | Active, not recruiting |
Izmit/Kocaeli, Turkey, 41380 | |
Local Institution - 359 | Recruiting |
Trabzon, Turkey, 61080 | |
Contact: Site 359 | |
Ukraine | |
Local Institution - 560 | Recruiting |
Cardiff, Ukraine, CF15 9SS | |
Contact: Site 560 | |
Local Institution - 914 | Recruiting |
Chernivtsi, Ukraine, 58001 | |
Contact: Site 914 | |
Local Institution - 950 | Recruiting |
Dnipropetrovsk, Ukraine, 49074 | |
Contact: Site 950 | |
Local Institution - 912 | Recruiting |
Ivano-Frankivsk, Ukraine, 76018 | |
Contact: Site 912 | |
Local Institution - 919 | Completed |
Kharkiv, Ukraine, 61018 | |
Local Institution - 901 | Recruiting |
Kyiv, Ukraine, 01030 | |
Contact: Site 901 | |
Local Institution - 915 | Recruiting |
Kyiv, Ukraine, 02000 | |
Contact: Site 915 | |
Local Institution - 911 | Recruiting |
Kyiv, Ukraine, 02175 | |
Contact: Site 911 | |
Local Institution - 918 | Recruiting |
Kyiv, Ukraine, 04053 | |
Contact: Site 918 | |
Local Institution - 908 | Recruiting |
Kyiv, Ukraine, 04107 | |
Contact: Site 908 | |
Local Institution - 562 | Recruiting |
Kyiv, Ukraine, 4210 | |
Contact: Site 562 | |
Local Institution - 910 | Completed |
Lviv, Ukraine, 79059 | |
Local Institution - 905 | Recruiting |
Poltava, Ukraine, 36011 | |
Contact: Site 905 | |
Local Institution - 934 | Completed |
Ternopil, Ukraine, 46008 | |
Local Institution - 909 | Recruiting |
Vinnytsia, Ukraine, 02029 | |
Contact: Site 909 | |
Local Institution - 971 | Recruiting |
Vinnytsia, Ukraine, 21018 | |
Contact: Site 971 | |
United Kingdom | |
Local Institution - 557 | Recruiting |
Birmingham, United Kingdom, B15 2SQ | |
Contact: Site 557 | |
Local Institution - 714 | Completed |
Bristol, United Kingdom, BS2 8HW | |
Local Institution - 558 | Recruiting |
Chorley, United Kingdom, PR7 7NA | |
Contact: Site 558 | |
Local Institution - 559 | Recruiting |
Corbridge Road, United Kingdom, NE46 1QJ | |
Contact: Site 559 | |
Local Institution - 712 | Completed |
Dundonald, United Kingdom, BT16 1RH | |
Local Institution - 713 | Completed |
Glasgow, United Kingdom, G51 4TF | |
Local Institution - 716 | Completed |
Lancashire Blackpool, United Kingdom, FY3 8NR | |
Local Institution - 722 | Recruiting |
London, United Kingdom, E1 1BB | |
Contact: Site 722 | |
Local Institution - 729 | Recruiting |
London, United Kingdom, NW1 2BU | |
Contact: Site 729 | |
Local Institution - 715 | Recruiting |
London, United Kingdom, SE1 9RT | |
Contact: Site 715 | |
Local Institution - 561 | Recruiting |
North Manchester Science Park, United Kingdom, M15 6SX | |
Contact: Site 561 | |
Local Institution - 593 | Recruiting |
Shrewsbury, United Kingdom, SY38XQ | |
Contact: Site 593 | |
Local Institution - 723 | Recruiting |
Southampton, United Kingdom, SO16 6YD | |
Contact: Site 723 | |
Local Institution - 718 | Completed |
Torquay, United Kingdom, TQ2 7AA |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT03440372 |
Other Study ID Numbers: |
RPC01-3201 U1111-1203-7225 ( Registry Identifier: WHO ) 2017-004292-31 ( EudraCT Number ) |
First Posted: | February 22, 2018 Key Record Dates |
Last Update Posted: | February 21, 2023 |
Last Verified: | February 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Crohn's Disease Crohn Disease Oral Ozanimod |
Moderately active Severely active RPC01 RPC01-3201 |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Ozanimod Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |