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 : May 17, 2022
|
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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 : | June 27, 2023 |
Estimated Study Completion Date : | September 25, 2023 |

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 |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | 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 | |
Elite Clinical Studies, LLC | Not yet recruiting |
Phoenix, Arizona, United States, 85018 | |
United States, Arkansas | |
Arkansas Gastroenterology, P.A. | Recruiting |
North Little Rock, Arkansas, United States, 72117 | |
United States, California | |
Sharp Chula Vista Medical Center | Recruiting |
Chula Vista, California, United States, 91911 | |
Valley View Internal Medicine | Recruiting |
Garden Grove, California, United States, 92843 | |
San Diego Clinical Trials | Recruiting |
La Mesa, California, United States, 91942 | |
Children's Hospital of Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Gastrointestinal Biosciences | Recruiting |
Los Angeles, California, United States, 90067 | |
VA Northern California Health Care System | Not yet recruiting |
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 | |
Medical Associates Research Group | Recruiting |
San Diego, California, United States, 92123 | |
United States, Colorado | |
Childrens Hospital Colorado | Not yet recruiting |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06510 | |
United States, Florida | |
Gastro Florida | Recruiting |
Clearwater, Florida, United States, 33756-3839 | |
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza | Recruiting |
Gainesville, Florida, United States, 32608 | |
Qway Research LLC | Recruiting |
Hialeah, Florida, United States, 33010 | |
Floridian Clinical Research LLC | Recruiting |
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 | |
Vista Health Research | Recruiting |
Homestead, Florida, United States, 33033 | |
Florida Center for Gastroenterology | Recruiting |
Largo, Florida, United States, 33777 | |
Nova Clinical Research Center LLC | Recruiting |
Miami, Florida, United States, 33125 | |
LCC Medical Research Institute, LLC | Completed |
Miami, Florida, United States, 33126 | |
Research Associates of South Florida LLC | Recruiting |
Miami, Florida, United States, 33156 | |
Advanced Research for Health Improvement | Recruiting |
Naples, Florida, United States, 34109 | |
NSB Research | Recruiting |
New Smyrna Beach, Florida, United States, 32168 | |
HMD Research LLC | Recruiting |
Orlando, Florida, United States, 32819 | |
Advanced Medical Research Center | Recruiting |
Port Orange, Florida, United States, 32127 | |
Asclepes Research Centers | Recruiting |
Weeki Wachee, Florida, United States, 34607 | |
United States, Georgia | |
Consultative Gastroenterology | Recruiting |
Atlanta, Georgia, United States, 30308 | |
Atlanta Gastroenterology Associates, LLC | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Children's Center for Digestive Healthcare | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Gastrointestinal Disease Research | Recruiting |
Columbus, Georgia, United States, 31904 | |
Gastroenterology Associates Of Central Georgia LLC | Recruiting |
Macon, Georgia, United States, 31201 | |
United States, Illinois | |
Rush University Medical Center - University Cardiovascular Surgeons | Recruiting |
Chicago, Illinois, United States, 60612 | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60622 | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60622 | |
Contact: Stephen Hanauer, Site 036 312-695-8952 | |
Carle Foundation Hospital | Recruiting |
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 | |
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. | Recruiting |
Lake Charles, Louisiana, United States, 70601 | |
Nola Research Works | Recruiting |
New Orleans, Louisiana, United States, 70125 | |
LSU Health Sciences Center Shreveport | Not yet recruiting |
Shreveport, Louisiana, United States, 71103 | |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | Not yet recruiting |
Baltimore, Maryland, United States, 21224 | |
Digestive Disease Associates, PA | Recruiting |
Catonsville, Maryland, United States, 21228 | |
Woodholme Gastroenterology Associates | Recruiting |
Glen Burnie, Maryland, United States, 21061 | |
United States, Massachusetts | |
Brigham and Women's Hospital - Crohn's and Colitis Center | Recruiting |
Chestnut Hill, Massachusetts, United States, 02467 | |
Baystate Medical Center | Recruiting |
Springfield, Massachusetts, United States, 01199 | |
United States, Michigan | |
Medex Research Institute | Recruiting |
Caro, Michigan, United States, 48723 | |
Revive Research Institute | Recruiting |
Southfield, Michigan, United States, 48034 | |
United States, Mississippi | |
Southern Therapy and Advanced Research | Recruiting |
Jackson, Mississippi, United States, 39216 | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Englewood Hospital and Medical Center | Recruiting |
Englewood, New Jersey, United States, 07631 | |
United States, New Mexico | |
University of New Mexico Hospital | Not yet recruiting |
Albuquerque, New Mexico, United States, 87106 | |
United States, New York | |
Advantage Clinical Trials | Completed |
Bronx, New York, United States, 10468 | |
NY Scientific | Recruiting |
Brooklyn, New York, United States, 11235 | |
Adirondack Medical Research Center | Not yet recruiting |
Glens Falls, New York, United States, 12801 | |
Northwell Health | Recruiting |
Great Neck, New York, United States, 11021 | |
Cornell University | Recruiting |
New York, New York, United States, 10021 | |
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 | |
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 | |
Asheville Gastroenterology Associates, P.A. | Recruiting |
Asheville, North Carolina, United States, 28801 | |
Carolinas HealthCare System Digestive Health | Recruiting |
Charlotte, North Carolina, United States, 28204 | |
Internal Medicine Research | Recruiting |
Charlotte, North Carolina, United States, 28207 | |
Carolina Research Center | Recruiting |
Greenville, North Carolina, United States, 27834 | |
United States, Ohio | |
Great Lakes Medical Research, LLC | Recruiting |
Beachwood, Ohio, United States, 44122 | |
Cleveland Clinic - Taussig Cancer Institute | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Local Institution - 018 | Active, not recruiting |
Cleveland, Ohio, United States, 44195 | |
Great Lakes Gastroenterology | Recruiting |
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 | |
Digestive Disease Specialists | Recruiting |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Penn State Milton S Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
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 289 843-876-1227 | |
United States, Tennessee | |
Local Institution - 121 | Active, not recruiting |
Nashville, Tennessee, United States, 37211 | |
Quality Medical Research | Completed |
Nashville, Tennessee, United States, 37211 | |
Vanderbilt University Medical Center | Recruiting |
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 | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Houston Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Biopharma Informatic Inc. Research Center | Completed |
Houston, Texas, United States, 77043 | |
GI Specialists of Houston | Completed |
Houston, Texas, United States, 77070 | |
Local Institution - 088 | Active, not recruiting |
Houston, Texas, United States, 77084 | |
Premier Vein and Vascular Center | Completed |
Houston, Texas, United States, 77084 | |
Sun Research Institute | Recruiting |
San Antonio, Texas, United States, 78215 | |
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 | |
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 | |
United States, Utah | |
University of Utah School of Medicine | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
University Of Utah School Of Medicine | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Jessica Johnson, Site 025 | |
United States, Virginia | |
Gastroenterology Associates, PC | Recruiting |
Gainesville, Virginia, United States, 20155 | |
Local Institution - 139 | Recruiting |
Petersburg, Virginia, United States, 23805 | |
Contact: Site 139 | |
Summit Clinical Research, LLC | 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 | |
Dermatologist Specialists of Spokane | Recruiting |
Spokane, Washington, United States, 99204 | |
United States, Wisconsin | |
Aurora Health Care Aurora Research | Completed |
Grafton, Wisconsin, United States, 53024 | |
Argentina | |
Sanatorio Guemes | Recruiting |
Ciudad Autonoma de Buenos Aires, Argentina, 1180 | |
Hospital Privado Centro Medico de Cordoba | Recruiting |
Cordoba, Argentina, X5016 | |
Instituto Medico de la Fundacion Estudios Clinicos | Completed |
Rosario, Argentina, 2000 | |
Universidad Nacional De Rosario - Hospital Provincial Del Centenario | Recruiting |
Rosario, Argentina, 2000 | |
Sanatorio 9 de Julio - CICE 9 de Julio | Recruiting |
San Miguel de Tucuman, Argentina, 4000 | |
Australia, New South Wales | |
Concord Repatriation General Hospital | Recruiting |
Concord, New South Wales, Australia, 2139 | |
Local Institution - 310 | Recruiting |
Concord, New South Wales, Australia, 2139 | |
Contact: Site 310 | |
Nepean Hospital | Recruiting |
Kingswood, New South Wales, Australia, 2747 | |
Wollongong Hospital | Recruiting |
Wollongong, New South Wales, Australia, 2500 | |
Australia, Queensland | |
Princess Alexandra Hospital | Recruiting |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
Royal Adelaide Hospital | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
The Queen Elizabeth Hospital | Recruiting |
Woodville South, South Australia, Australia, 5011 | |
Australia, Western Australia | |
Harry Perkins Medical Research Institute, Fiona Stanley Hospital | Recruiting |
Murdoch, Western Australia, Australia, 6150 | |
Australia | |
Ballarat Base Hospital | Not yet recruiting |
Ballarat, Australia, 3350 | |
Belarus | |
Grodno City Clinical Hospital #4 | Active, not recruiting |
Grodno, Belarus, 230026 | |
Vitebsk Regional Clinical Specialized Center | Active, not recruiting |
Vitebsk, Belarus, 210604 | |
Belgium | |
Algemeen Ziekenhuis Klina | Recruiting |
Brasschaat, Belgium, 2930 | |
Universitair Ziekenhuis Brussel | Recruiting |
Brussels, Belgium, 1090 | |
University Hospital Brussels | Not yet recruiting |
Brussels, Belgium, 1090 | |
CHU Saint-Luc | Not yet recruiting |
Brussels, Belgium, 1200 | |
Queen Fabiola Children's University Hospital | Not yet recruiting |
Brussels, Belgium, 1200 | |
Universitair Ziehenhuis Antwerpen | Recruiting |
Edegem, Belgium, 2650 | |
Universitair Ziekenhuis Gent | Recruiting |
Ghent, Belgium, 9000 | |
Local Institution - 942 | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Site 942 | |
Universitair Ziekenhuis Leuven, Campus Gasthuisberg | Recruiting |
Leuven, Belgium, 3000 | |
Clinique du Montlegia | Recruiting |
Liege, Belgium, 4000 | |
Local Institution - 938 | Recruiting |
Seraing, Belgium, 4100 | |
Contact: Site 938 | |
Sart Tilman Hospital Department of Gastroenterology and Hepatology | Recruiting |
Seraing, Belgium, 4100 | |
Hospital Centre of Walloon Picarde | Recruiting |
Tournai, Belgium, 7500 | |
Bosnia and Herzegovina | |
University Clinical Centre of the Republic of Srpska | Recruiting |
Banja Luka, Bosnia and Herzegovina, 78000 | |
University Clinical Hospital Mostar | Completed |
Mostar, Bosnia and Herzegovina, 88000 | |
Clinical Center University of Sarajevo | Completed |
Sarajevo, Bosnia and Herzegovina, 71000 | |
General Hospital "Prim.dr. Abdulah Nakas" | Recruiting |
Sarajevo, Bosnia and Herzegovina, 71000 | |
Bulgaria | |
Multiprofile Hospital for Active Treatment Medline | Recruiting |
Plovdiv, Bulgaria, 4002 | |
Second MHAT Sofia AD | Recruiting |
Sofia, Bulgaria, 1202 | |
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD | Recruiting |
Sofia, Bulgaria, 1606 | |
Local Institution - 748 | Recruiting |
Sofia, Bulgaria, 1784 | |
Contact: Site 748 | |
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia | Recruiting |
Sofia, Bulgaria, 1784 | |
ACIBADEM City Clinic Medical Center Bregalnitsa | Completed |
Varna, Bulgaria, 9002 | |
Canada, Alberta | |
Local Institution - 273 | Recruiting |
Calgary, Alberta, Canada, T2N 4Z6 | |
Contact: Site 273 | |
University of Calgary Health - The Gastrointestinal Research Group (GIRG) | Recruiting |
Calgary, Alberta, Canada, T2N 4Z6 | |
Canada, British Columbia | |
Okanagan Clinical Trials Ltd | Completed |
Kelowna, British Columbia, Canada, V1Y 1Z9 | |
Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre | Completed |
Vancouver, British Columbia, Canada, V5Z1M9 | |
Canada, Manitoba | |
Winnipeg Clinic Dermatology Research | Completed |
Winnipeg, Manitoba, Canada, R3CON2 | |
Canada, Nova Scotia | |
Viable Clinical Research | Recruiting |
Bridgewater, Nova Scotia, Canada, B4V 3N2 | |
Canada, Ontario | |
Local Institution - 252 | Recruiting |
London, Ontario, Canada, N6A 5A5 | |
Contact: Site 252 | |
London Health Sciences Centre, University Hospital | Recruiting |
London, Ontario, Canada, N6A 5A5 | |
LHSC Victoria Hospital | Recruiting |
London, Ontario, Canada, N6A 5W9 | |
Toronto Digestive Disease Associates Inc | Recruiting |
Vaughan, Ontario, Canada, L4L 4Y7 | |
Chile | |
Local Institution - 390 | Recruiting |
Santiago, Chile, 8320000 | |
Contact: Site 390 | |
Croatia | |
Clinical Hospital Center Osijek | Recruiting |
Osijek, Croatia, 31000 | |
Clinical Hospital Centre Rijeka | Completed |
Rijeka, Croatia, 51000 | |
Clinical Hospital Center Split | Recruiting |
Split, Croatia, HR-21000 | |
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases | Recruiting |
Zagreb, Croatia, 10000 | |
Clinical Hospital Dubrava | Completed |
Zagreb, Croatia, 10000 | |
University Hospital Centre Zagreb, Clinic of Internal Diseases | Recruiting |
Zagreb, Croatia, 10000 | |
Czechia | |
Local Institution - 767 | Recruiting |
Brno, Czechia, 615 00 | |
Contact: Site 767 | |
Military Hospital Brno | Recruiting |
Brno, Czechia, 615 00 | |
St. Anne's University Hospital Brno | Recruiting |
Brno, Czechia, 656 91 | |
Hepato-Gastroenterologie HK, s. r. o. | Recruiting |
Hradec Králové, Czechia, 500 12 | |
Soukroma Gastroenterologicka ambulance a endoskopie | Recruiting |
Most, Czechia, 43401 | |
PreventaMed | Recruiting |
Olomouc, Czechia, 77900 | |
Krajská nemocnice Pardubice, Kožní oddelení | Recruiting |
Pardubice, Czechia, 532 03 | |
University Hospital Pilsen | Recruiting |
Plzen, Czechia, 30460 | |
University Hospital Motol | Completed |
Prague 5, Czechia, 150 06 | |
ISCARE, a.s. | Recruiting |
Prague 9, Czechia, 190 00 | |
Institut klinicke a experimentalni mediciny | Recruiting |
Praha 4, Czechia, 14021 | |
Denmark | |
Bispebjerg Hospital | Completed |
Copenhagen, Denmark, 2400 | |
Holbaek Hospital | Completed |
Holbaek, Denmark, 4300 | |
Nykobing F Hospital | Completed |
Nykobing F, Denmark, 4800 | |
Finland | |
Turku University Hospital | Recruiting |
Turku, Finland, FI-20520 | |
France | |
CHU Amiens Picardie - Site Sud | Recruiting |
Amiens cedex 1, France, 80054 | |
Centre Hospitalier Intercommunal de Creteil | Recruiting |
Creteil Cedex, France, 94010 | |
CHU de Dijon Bourgogne - Hopital Francois Mitterand | Recruiting |
Dijon Cedex, France, 21079 | |
CHU de Grenoble Alpes | Recruiting |
Grenoble Cedex 9, France, 38700 | |
CHRU de Lille - Hopital Claude Huriez | Recruiting |
Lillie Cedex, France, 59037 | |
Local Institution - 633 | Recruiting |
Lillie Cedex, France, 59037 | |
Contact: Site 633 | |
Hopital Nord | Not yet recruiting |
Marseille cedex 20, France, 13915 | |
Hospital Pontchaillou | Recruiting |
Rennes, France, 35033 | |
CHU de Rouen Hopital Charles Nicolle | Recruiting |
Rouen Cedex, France, 76031 | |
CHU de Toulouse Hopital Rangueil | Recruiting |
Toulouse Cedex 09, France, 31059 | |
Germany | |
Charite - Universitaetsmedizin Berlin | Recruiting |
Berlin, Germany, 10117 | |
Gastroenterology Am Bayerischen Platz | Recruiting |
Berlin, Germany, 10825 | |
DRK Clinics Berlin | Recruiting |
Berlin, Germany, 14050 | |
Local Institution - 650 | Recruiting |
Berlin, Germany, 14050 | |
Contact: Site 650 | |
Agaplesion Markus Krankenhaus | Recruiting |
Frankfurt, Germany, 60431 | |
Interdisciplinary Crohn Colitis Center Rhein Main | Recruiting |
Frankfurt, Germany, 60594 | |
Local Institution - 654 | Recruiting |
Frankfurt, Germany, 60594 | |
Contact: Site 654 | |
University Hospital Hamburg-Eppendorf | Recruiting |
Hamburg, Germany, 20246 | |
Universitaetsklinikum Leipzig AoeR | Recruiting |
Leipzig, Germany, 04103 | |
Practice for Gastroenterology and Internal Medicine | Recruiting |
Ludwigshafen am Rhein, Germany, 67067 | |
St Marien und St Annastiftskrankenhaus | Recruiting |
Ludwigshafen am Rhein, Germany, 67067 | |
Synesis Research Center | Not yet recruiting |
Munich, Germany, 80331 | |
Local Institution - 666 | Recruiting |
Tuebingen, Germany, 72076 | |
Contact: Site 666 | |
Universitaetsklinikum Tuebingen | Recruiting |
Tuebingen, Germany, 72076 | |
Universitaetsklinikum Ulm | Recruiting |
Ulm, Germany, 89081 | |
Ireland | |
St Vincent's University Hospital | Recruiting |
Dublin 4, Dublin, Ireland, DO4 T6F4 | |
Beaumont Hospital | Recruiting |
Dublin 9, Ireland, D09 V2N0 | |
Local Institution - 973 | Recruiting |
Dublin 9, Ireland, D09 V2N0 | |
Contact: Site 973 | |
Israel | |
Bat Yamon Medical Center, Clalit Medical Services | Completed |
Bat Yam, Israel, 5962025 | |
Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel, 91031 | |
Galilee Medical Center | Recruiting |
Nahariya, Israel, 22100 | |
Local Institution - 344 | Completed |
Nahariya, Israel, 22100 | |
Chaim Sheba Medical Center | Recruiting |
Ramat Gan, Israel, 52621 | |
Kaplan Medical Center | Recruiting |
Rechovot, Israel, 76100 | |
Italy | |
University Polyclinic Hospital of Bari | Not yet recruiting |
Bari, Italy, 70124 | |
Polyclinic S. Orsola-Malpighi | Recruiting |
Bologna, Italy, 40138 | |
Civil Hospital of Brescia | Recruiting |
Brescia, Italy, 25123 | |
Poliambulanza Hospital | Recruiting |
Brescia, Italy, 25124 | |
IRCCS "Savario De Bellis" | Recruiting |
Castellana Grotte, Italy, 70013 | |
University Hospital Mater Domini | Recruiting |
Catanzaro, Italy, 88100 | |
"Ss. Annunziata" Policlinic of Chieti | Recruiting |
Chieti, Italy, 66100 | |
University Polyclinic Hospital G. Martino | Recruiting |
Messina, Italy, 98125 | |
Maggiore Polyclinic Hospital, IRCCS Ca' Granda | Completed |
Milano, Italy, 20122 | |
Humanitas Research Hospital - Humanitas Mirasole S.p.A | Recruiting |
Milan, Italy, 20089 | |
Azienda Socio Sanitaria Territoriale (ASST) di Monza | Recruiting |
Monza, Italy, 20900 | |
Hospital of Di Padova | Recruiting |
Padova, Italy, 35128 | |
Local Institution - 685 | Recruiting |
Padova, Italy, 35128 | |
Contact: Site 685 | |
United Hospitals Villa Sofia Cervello | Recruiting |
Palermo, Italy, 90146 | |
Polyclinic San Matteo IRCCS | Recruiting |
Pavia, Italy, 27100 | |
Polyclinic Tor Vergata | Recruiting |
Roma, Italy, 00133 | |
Univerisity Polyclinic Foundation Agostino Gemelli | Recruiting |
Roma, Italy, 00168 | |
Azienda Ospedaliera San Camillo Forlanini | Recruiting |
Rome, Italy, 00152 | |
Integrated University Hospital Santa Maria della Misericordia of Udine | Recruiting |
Udine, Italy, 33100 | |
A.O. Universitaria Fondazione Macchi | Recruiting |
Varese, Italy, 21100 | |
Local Institution - 676 | Recruiting |
Verona, Italy, 37024 | |
Contact: Site 676 | |
Sacred Heart Don Calabria | Recruiting |
Verona, Italy, 37024 | |
Korea, Republic of | |
Korea University Medical Center - Korea University Ansan Hospital | Completed |
Ansan, Korea, Republic of, 152-703 | |
Local Institution - 441 | Recruiting |
Busan, Korea, Republic of, 49201 | |
Contact: Site 441 | |
Hanyang University Guri Hospital | Recruiting |
Guri-si, Korea, Republic of, 11923 | |
Seoul National University Bundang Hospital | Recruiting |
Seongnam-si, Korea, Republic of, 13620 | |
Severance Hospital | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of, 135-710 | |
Kangbuk Samsung Hospital | Recruiting |
Seoul, Korea, Republic of, 3181 | |
Ewha Womans University Mokdong Hospital | Recruiting |
Seoul, Korea, Republic of, 7985 | |
Latvia | |
P. Stradins Clinical University Hospital | Recruiting |
Riga, Latvia, LV-1002 | |
Digestive Diseases Center Gastro | Recruiting |
Riga, Latvia, LV-1006 | |
Riga East Clinical University Hospital clinic Gailezers | Recruiting |
Riga, Latvia, LV-1038 | |
Mexico | |
Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V. | Recruiting |
Zapapan, Jalisco, Mexico, 45030 | |
Centro Regiomontano de Estudios Clinicos Roma SC. | Recruiting |
Monterrey, Nuevo León, Mexico, 64610 | |
Instituto Tecnológico y de Estudios Superiores de Monterrey | Recruiting |
Monterrey, Nuevo León, Mexico, 64718 | |
SMIQ | Recruiting |
Santiago de Queretaro, Querétaro, Mexico, 76070 | |
Hospital Christus Muquerza del Parque S.A. de C.V. | Recruiting |
Chihuahua, Mexico, 31020 | |
Centro de Investigacion Clinica Acelerada (CICA) S.C. | Recruiting |
Mexico, Mexico, 07020 | |
Local Institution - 527 | Recruiting |
Mexico, Mexico, 07020 | |
Contact: Site 527 | |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Recruiting |
Tlalpan, Mexico, 14080 | |
Moldova, Republic of | |
"Sfanta Treime" Clinical Municipal Hospital | Recruiting |
Chisinau, Moldova, Republic of, MD-2068 | |
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery | Completed |
Chisinau, Moldova, Republic of, MD2005 | |
"Sf. Arhanghel Mihail" Municipal Clinical Hospital | Recruiting |
Chisinau, Moldova, Republic of, MD2025 | |
Local Institution - 809 | Recruiting |
Chisinau, Moldova, Republic of, MD2025 | |
Contact: Site 809 | |
Republican Clinical Hospital, Department of Colorectal Surgery | Recruiting |
Chisinau, Moldova, Republic of, MD2025 | |
Republican Clinical Hospital | Recruiting |
Chisinau, Moldova, Republic of, MD2025 | |
Norway | |
Akershus University Hospital | Not yet recruiting |
Lørenskog, Norway, 1478 | |
Lovisenberg Diakonale Sykehus | Not yet recruiting |
Oslo, Norway, 0440 | |
Poland | |
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego | Recruiting |
Bialystok, Poland, 15-276 | |
Medical Services Center MaxMed | Recruiting |
Bochnia, Poland, 32-700 | |
Nzoz All-Medicus | Completed |
Katowice, Poland, 40-660 | |
Kornel Gibinski Independent Public Central Clinical Hospital in Katowice | Recruiting |
Katowice, Poland, 40-752 | |
GLOBE Clinical Research Sp. z o.o. LLC | Recruiting |
Klodzko, Poland, 57-300 | |
Local Institution - 817 | Recruiting |
Klodzko, Poland, 57-300 | |
Contact: Site 817 | |
PLEJADY Sp. z o.o. (LLC) Medical Centre | Recruiting |
Krakow, Poland, 30-363 | |
Landa Specialist Doctor's Offices | Recruiting |
Krakow, Poland, 31-156 | |
Local Institution - 823 | Recruiting |
Krakow, Poland, 31-156 | |
Contact: Site 823 | |
Krakow Medical Center LLC | Recruiting |
Krakow, Poland, 31-501 | |
Santa Familia Centrum Badan, Profilaktyki i Leczenia | Recruiting |
Lodz, Poland, 90-302 | |
Local Institution - 888 | Active, not recruiting |
Lodz, Poland, 91-839 | |
Salve Limited Liability Company Limited Partnership, Outpatient Clinic | Recruiting |
Lodz, Poland, 91-839 | |
1 Military Clinical Hospital in Lublin | Recruiting |
Lublin, Poland, 20-049 | |
Local Institution - 760 | Recruiting |
Lublin, Poland, 20-049 | |
Contact: Site 760 | |
Local Institution - 830 | Recruiting |
Olsztyn, Poland, 10-561 | |
Contact: Site 830 | |
Provincial Specialist Hospital in Olsztyn | Recruiting |
Olsztyn, Poland, 10-561 | |
SOLUMED Medical Center | Recruiting |
Poznan, Poland, 60-529 | |
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe | Completed |
Torun, Poland, 87-100 | |
H-T. Medical Center Sp. z o.o. LLC Limited Partnership | Recruiting |
Tychy, Poland, 43-100 | |
Local Institution - 824 | Recruiting |
Tychy, Poland, 43-100 | |
Contact: Site 824 | |
Polimedica | Recruiting |
Ul. Piotrkowska 177, Poland, 90-447 | |
Maternal Pediatric and Adolescent Healthcare Centre | Recruiting |
Warsaw, Poland, 00-632 | |
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED | Completed |
Warszawa, Poland, 03-580 | |
Romania | |
Hyperclinica MedLife Grivita | Recruiting |
Bucharest, Romania, 010719 | |
Center of Diagnosis and Treatment Provita | Recruiting |
Bucharest, Romania, 021494 | |
Local Institution - 795 | Recruiting |
Bucharest, Romania, 021494 | |
Contact: Site 795 | |
Fundeni Clinical Institute | Recruiting |
Bucharest, Romania, 022328 | |
Bucharest University Emergency Hospital, Department of Internal Medicine II | Recruiting |
Bucharest, Romania, 050098 | |
Dr. Carol Davila Central Military Emergency Clinical Hospital | Recruiting |
Bucharest, Romania, 10825 | |
Local Institution - 842 | Recruiting |
Bucharest, Romania, 10825 | |
Contact: Site 842 | |
Craiova County Emergency Clinical Hospital | Recruiting |
Craiova, Romania, 200642 | |
Colentina Clinical Hospital | Recruiting |
Napoca, Romania, 400001 | |
Local Institution - 838 | Recruiting |
Napoca, Romania, 400001 | |
Contact: Site 838 | |
Targu Mures County Emergency Clinical Hospital | Recruiting |
Targu Mures, Romania, 540136 | |
Russian Federation | |
Chita State Medical Academy | Active, not recruiting |
Chita, Russian Federation, 672090 | |
Local Institution - 598 | Recruiting |
Chita, Russian Federation, 672090 | |
Contact: Site 598 | |
Irkutsk State Medical Academy of Postgraduate Education | Active, not recruiting |
Irkutsk, Russian Federation, 664049 | |
City Clinical Hospital No 7 - Kazan | Active, not recruiting |
Kazan, Russian Federation, 420103 | |
Local Institution - 892 | Recruiting |
Kazan, Russian Federation, 420103 | |
Contact: Site 892 | |
Regional Clinical Hospital | Active, not recruiting |
Khanty-mansiysk, Russian Federation, 628012 | |
Federal Siberian Research and Clinical Center | Active, not recruiting |
Krasnoyarsk, Russian Federation, 660037 | |
Moscow Clinical Scientific and Practical Center | Completed |
Moscow, Russian Federation, 111123 | |
Novosibirskiy Gastrocenter | Active, not recruiting |
Novosibirsk, Russian Federation, 630007 | |
Republican Hospital na VA Baranov | Active, not recruiting |
Petrozavodsk, Russian Federation, 185019 | |
Evromedservis | Active, not recruiting |
Pushkin, Russian Federation, 196603 | |
Clinic UZI 4D, LLC | Active, not recruiting |
Pyatigorsk, Russian Federation, 357502 | |
Pyatigorsk City Hospital 2 | Active, not recruiting |
Pyatigorsk, Russian Federation, 357538 | |
Rostov State Medical University | Active, not recruiting |
Rostov-on-Don, Russian Federation, 344022 | |
Medical Center Reavita Med Spb LLC | Completed |
Saint Petersburg, Russian Federation, 194354 | |
Samara Station Railway Clinical Hospital under OAO Russian Railways | Active, not recruiting |
Samara, Russian Federation, 443041 | |
S.M. Kirov Military Medical Academy | Active, not recruiting |
St Petersburg, Russian Federation, 194044 | |
Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office | Active, not recruiting |
St. Petersburg, Russian Federation, 195067 | |
SPb SBIH City Hospital of Saint Martyr Elizaveta | Active, not recruiting |
St. Petersburg, Russian Federation, 195257 | |
Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital | Not yet recruiting |
Surgut, Russian Federation, 628408 | |
Local Institution - 806 | Recruiting |
Tula, Russian Federation, 300053 | |
Contact: Site 806 | |
Tula Regional Clinical Hospital | Active, not recruiting |
Tula, Russian Federation, 300053 | |
City Clinical Hospital #21 | Active, not recruiting |
Ufa, Russian Federation, 450071 | |
Ulyanovsk Regional Clinical Hospital | Not yet recruiting |
Ulyanovsk, Russian Federation, 432017 | |
Novgorod Regional Clinical Hospital | Active, not recruiting |
Veliky Novgorod, Russian Federation, 173008 | |
Regional Clinical Hospital | Not yet recruiting |
Vladimir, Russian Federation, 600023 | |
Primorsky Regional Clinical Hospital No.1 | Active, not recruiting |
Vladivostok, Russian Federation, 690091 | |
Medical Center of Far-Eastern Federal University | Active, not recruiting |
Vladivostok, Russian Federation, 690922 | |
Saudi Arabia | |
King Fahad Specialist Hospital | Completed |
Dammam, Saudi Arabia, 32253 | |
King Abdul Aziz University Hospital | Recruiting |
Jeddah, Saudi Arabia, 22252 | |
Local Institution - 537 | Recruiting |
Jeddah, Saudi Arabia, 22252 | |
Contact: Site 537 | |
King Saud Medical Complex | Recruiting |
Riyadh, Saudi Arabia, 12746 | |
Local Institution - 536 | Recruiting |
Riyadh, Saudi Arabia, 12746 | |
Contact: Site 536 | |
King Fahad National Guard Hospital | Recruiting |
Riyadh, Saudi Arabia, 14611 | |
Spain | |
General University Hospital of Alicante | Recruiting |
Alicante, Spain, 03010 | |
Local Institution - 690 | Recruiting |
Badalona, Spain, 08916 | |
Contact: Site 690 | |
University Hospital Germans Trias i Pujol | Recruiting |
Badalona, Spain, 08916 | |
University Hospital of the Canary Islands (HUC) La Laguna | Recruiting |
La Laguna, Spain, 38320 | |
University Hospital de La Princesa | Recruiting |
Madrid, Spain, 28006 | |
University Hospital La Paz | Recruiting |
Madrid, Spain, 28046 | |
University Hospital Virgen Macarena | Recruiting |
Sevilla, Spain, 41009 | |
University Hospital Virgen del Rocio | Recruiting |
Sevilla, Spain, 41013 | |
Viladecans Hospital | Recruiting |
Viladecans, Spain, 08840 | |
Switzerland | |
Lindenhofspital | Recruiting |
Bern, Switzerland, 3001 | |
Local Institution - 967 | Recruiting |
Bern, Switzerland, 3001 | |
Contact: Site 967 | |
Cantonal Hospital Saint Gallen | Recruiting |
St.Gallen, Switzerland, 9007 | |
University Hospital Zurich | Recruiting |
Zurich, Switzerland, 8091 | |
Taiwan | |
Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi | Recruiting |
Kozlu, Taiwan, 67000 | |
Turkey | |
Ankara University Medical Faculty Cebeci Hospital | Completed |
Ankara, Turkey, 06590 | |
Uludag Universitesi Tip Fakultesi | Completed |
Bursa, Turkey, 16059 | |
Bezmialem Foundation University Medical Faculty | Recruiting |
Istanbul, Turkey, 34093 | |
Local Institution - 362 | Recruiting |
Istanbul, Turkey, 34093 | |
Contact: Site 362 | |
Marmara University | Completed |
Istanbul, Turkey, 34840 | |
Goztepe Prof. Dr. Suleyman Yalcin City Hospital | Recruiting |
Kadiköy/Istanbul, Turkey, 41380 | |
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi | Recruiting |
Trabzon, Turkey, 61080 | |
Ukraine | |
Chernivtsi Regional Clinical Hospital | Active, not recruiting |
Chernivtsi, Ukraine, 58001 | |
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases | Active, not recruiting |
Dnipropetrovsk, Ukraine, 49074 | |
Ivano-Frankivsk Central City Clinical Hospital | Active, not recruiting |
Ivano-Frankivsk, Ukraine, 76018 | |
V.T. Zaitsev Institute of General and Emergency Surgery | Completed |
Kharkiv, Ukraine, 61018 | |
Kyiv City Clinical Hospital #18 | Active, not recruiting |
Kyiv, Ukraine, 01030 | |
Medical Center Consilium Medical | Active, not recruiting |
Kyiv, Ukraine, 02000 | |
Ok Clinic Medical Center within International Institute of Clinical Trials, LLC | Active, not recruiting |
Kyiv, Ukraine, 02175 | |
Kyiv Regional Hospital #2 | Active, not recruiting |
Kyiv, Ukraine, 04053 | |
Kyiv Regional Clinical Hospital | Active, not recruiting |
Kyiv, Ukraine, 04107 | |
Local Institution - 562 | Recruiting |
Kyiv, Ukraine, 4210 | |
Contact: Site 562 | |
Public City Clinical Hospital of Emergency Medical Care | Completed |
Lviv, Ukraine, 79059 | |
Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council | Active, not recruiting |
Poltava, Ukraine, 36011 | |
Ternopil City Public Emergency Medical Care Hospital | Active, not recruiting |
Ternopil, Ukraine, 46008 | |
Local Institution - 909 | Recruiting |
Vinnytsia, Ukraine, 02029 | |
Contact: Site 909 | |
Vinnytsia City Clinical Hospital #1 | Active, not recruiting |
Vinnytsia, Ukraine, 02029 | |
Vinnytsia M.I. Pyrohov Regional Clinical Hospital | Active, not recruiting |
Vinnytsia, Ukraine, 21018 | |
First Private Clinic | Not yet recruiting |
Zhytomyr, Ukraine, 10003 | |
United Kingdom | |
Bristol Royal Infirmary | Completed |
Bristol, United Kingdom, BS2 8HW | |
Ulster Hospital | Recruiting |
Dundonald, United Kingdom, BT16 1RH | |
Queen Elizabeth University Hospital | Recruiting |
Glasgow, United Kingdom, G51 4TF | |
Victoria Hospital Blackpool | Recruiting |
Lancashire Blackpool, United Kingdom, FY3 8NR | |
Local Institution - 722 | Recruiting |
London, United Kingdom, E1 1BB | |
Contact: Site 722 | |
Royal London Hospital | Recruiting |
London, United Kingdom, E1 1BB | |
University College London Hospitals NHS Foundation Trust - University College Hospital | Not yet recruiting |
London, United Kingdom, NW1 2BU | |
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital | Recruiting |
London, United Kingdom, SE1 9RT | |
John Radcliffe Hospital | Not yet recruiting |
Oxford, United Kingdom, OX3 9DU | |
Royal Shrewsbury Hospital | Not yet recruiting |
Shrewsbury, United Kingdom, SY38XQ | |
Local Institution - 723 | Recruiting |
Southampton, United Kingdom, SO16 6YD | |
Contact: Site 723 | |
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital | Recruiting |
Southampton, United Kingdom, SO16 6YD | |
Torbay Hospital | Recruiting |
Torquay, United Kingdom, TQ2 7AA |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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: | May 17, 2022 |
Last Verified: | May 2022 |
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 |