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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03440372
• Other study ID #: RPC01-3201
• Secondary ID: U1111-1203-72252
• Status: Recruiting
• Phase: Phase 3
• Start date: February 27, 2018
• Est. completion date: March 24, 2025

Study information

• Verified date: March 2024
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 24, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Ozanimod
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 500	Buenos Aires
Argentina	Local Institution - 501	Buenos Aires
Argentina	Local Institution - 568	Buenos Aires
Argentina	Local Institution - 571	Buenos Aires
Argentina	Local Institution - 494	Ciudad Autonoma de Buenos Aires
Argentina	Local Institution - 495	Cordoba
Argentina	Local Institution - 570	Cordoba
Argentina	Local Institution - 569	Mar del Plata
Argentina	Local Institution - 496	Rosario
Argentina	Local Institution - 497	Rosario
Argentina	Local Institution - 502	Rosario, Santa Fe
Argentina	Local Institution - 492	San Miguel de Tucuman
Australia	Local Institution - 308	Adelaide	South Australia
Australia	Lyell McEwin Hospital	Adelaide	South Australia
Australia	Local Institution - 325	Bankstown
Australia	Box Hill Hospital and Eastern Clinical Research Unit	Box Hill
Australia	Local Institution - 310	Concord	New South Wales
Australia	Local Institution - 319	Kingswood	New South Wales
Australia	Local Institution - 707	Maroochydore	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Local Institution - 316	Murdoch	Western Australia
Australia	Local Institution - 324	Sydney, NSW
Australia	Local Institution - 323	Wollongong	New South Wales
Australia	Local Institution - 320	Woodville South	South Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belarus	Local Institution - 745	Grodno
Belarus	Local Institution - 737	Vitebsk
Belgium	Local Institution - 943	Brasschaat	Antwerpen
Belgium	Local Institution - 940	Brussels
Belgium	Local Institution - 939	Edegem
Belgium	Local Institution - 937	Ghent
Belgium	Local Institution - 942	Leuven
Belgium	Local Institution - 936	Liege
Belgium	Local Institution - 938	Seraing
Belgium	Local Institution - 941	Tournai
Bosnia and Herzegovina	Local Institution - 743	Banja Luka
Bosnia and Herzegovina	Local Institution - 741	Mostar
Bosnia and Herzegovina	Local Institution - 738	Sarajevo
Bosnia and Herzegovina	Local Institution - 742	Sarajevo
Bulgaria	Multiprofile Hospital for Active Treatment - Blagoevgrad	Blagoevgrad
Bulgaria	Local Institution - 746	Plovdiv
Bulgaria	Local Institution - 747	Sofia
Bulgaria	Local Institution - 748	Sofia
Bulgaria	Local Institution - 749	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD	Sofia
Bulgaria	Local Institution - 553	Stara Zagora
Bulgaria	Local Institution - 754	Varna
Canada	Local Institution - 268	Bridgewater	Nova Scotia
Canada	Local Institution - 273	Calgary	Alberta
Canada	GIRI Gastroenterology and Internal Medicine Research Institute	Edmonton	Alberta
Canada	Local Institution - 263	Kelowna	British Columbia
Canada	LHSC Victoria Hospital	London	Ontario
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	Local Institution - 275	Toronto	Ontario
Canada	Local Institution - 255	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates Inc	Vaughan	Ontario
Canada	Local Institution - 261	Winnipeg	Manitoba
Chile	Local Institution - 389	Concepción
Chile	Local Institution - 393	La Serena
Chile	Local Institution - 387	Santiago
Chile	Local Institution - 390	Santiago
Chile	Local Institution - 391	Santiago
Chile	Medical Services Society	Santiago
Croatia	Local Institution - 453	Koprivnica
Croatia	Local Institution - 763	Osijek
Croatia	Local Institution - 764	Rijeka
Croatia	Local Institution - 765	Split
Croatia	Local Institution - 452	Zagreb
Croatia	Local Institution - 761	Zagreb
Croatia	Local Institution - 762	Zagreb
Croatia	Local Institution - 766	Zagreb
Czechia	Local Institution - 767	Brno
Czechia	Local Institution - 772	Brno
Czechia	Local Institution - 773	Hradec Králové
Czechia	Local Institution - 775	Most
Czechia	Local Institution - 771	Olomouc
Czechia	Local Institution - 774	Pardubice
Czechia	Local Institution - 769	Plzen
Czechia	Clinoxus s.r.o Outpatient Clinic Budejovicka	Prague
Czechia	Local Institution - 573	Prague
Czechia	Local Institution - 768	Prague 5
Czechia	Local Institution - 770	Prague 9
Czechia	Local Institution - 776	Praha 4
Denmark	Local Institution - 611	Copenhagen
Denmark	Local Institution - 610	Holbaek
Denmark	Local Institution - 609	Nykobing F
Finland	Local Institution - 614	Turku
France	Local Institution - 638	Amiens cedex 1
France	Local Institution - 711	Creteil Cedex
France	Local Institution - 616	Dijon Cedex
France	Local Institution - 615	Grenoble Cedex 9
France	Local Institution - 633	Lillie Cedex
France	Local Institution - 646	Marseille cedex 20
France	Saint Eloi Hospital	Montpellier
France	Local Institution - 641	Rennes
France	Local Institution - 612	Rouen Cedex
France	Local Institution - 643	Toulouse Cedex 09
Georgia	Helsicore - Israeli Georgian Medical Research Clinic	Tbilisi
Georgia	Local Institution - 250	Tbilisi
Georgia	LTD The First Medical Center	Tbilisi
Georgia	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC	Tbilisi
Germany	Local Institution - 626	Berlin
Germany	Local Institution - 650	Berlin
Germany	Local Institution - 665	Berlin
Germany	Local Institution - 654	Frankfurt
Germany	Local Institution - 662	Frankfurt
Germany	Local Institution - 659	Hamburg
Germany	Local Institution - 337	Leipzig
Germany	Local Institution - 651	Leipzig
Germany	Local Institution - 655	Ludwigshafen am Rhein
Germany	Local Institution - 730	Ludwigshafen am Rhein
Germany	Local Institution - 661	Stuttgart
Germany	Local Institution - 666	Tuebingen
Germany	Local Institution - 663	Ulm
India	Local Institution - 333	Belgaum	Karnataka
India	Sri Ramakrishna Hospital	Coimbatore	Tamil Nadu
India	G.B. Pant Hospital	Delhi
India	Fortis Memorial Research Institute (FMRI)	Gurgaon	Haryana
India	Asian Institute Of Gastroenterology	Hyderabad	Telangana
India	Yashoda Hospitals Hitec City	Hyderabad	Andhra Pradesh
India	S R Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	SMS Medical College & Attached Hospitals	Jaipur	Rajasthan
India	Amrita Institute Of Medical Sciences	Kochi	Kerala
India	Local Institution - 409	Kochi	Kerala
India	Dayanand Medical College And Hospital	Ludhiana	Punjab
India	All India Institute Of Medical Sciences	New Delhi
India	Surat Institute of Digestive Sciences	Surat	Gujarat
Ireland	Local Institution - 975	Dublin 4	Dublin
Ireland	Beaumont Hospital	Dublin 9
Israel	Local Institution - 345	Bat Yam
Israel	Local Institution - 339	Jerusalem
Israel	Local Institution - 344	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Local Institution - 338	Rechovot
Italy	Local Institution - 677	Bologna
Italy	Local Institution - 684	Brescia
Italy	Poliambulanza Hospital	Brescia
Italy	Local Institution - 689	Castellana Grotte
Italy	Local Institution - 679	Catanzaro
Italy	Local Institution - 687	Chieti
Italy	Local Institution - 674	Messina
Italy	Local Institution - 672	Milan
Italy	Local Institution - 334	Milano
Italy	Local Institution - 686	Milano
Italy	Local Institution - 678	Monza
Italy	Local Institution - 685	Padova
Italy	Local Institution - 682	Palermo
Italy	Local Institution - 673	Pavia
Italy	Local Institution - 675	Roma
Italy	Local Institution - 681	Roma
Italy	Local Institution - 671	Rome
Italy	Local Institution - 680	Udine
Italy	Local Institution - 670	Varese
Italy	Local Institution - 676	Verona
Korea, Republic of	Local Institution - 437	Ansan
Korea, Republic of	Local Institution - 441	Busan
Korea, Republic of	Local Institution - 435	Guri-si
Korea, Republic of	Local Institution - 436	Seongnam-si
Korea, Republic of	Local Institution - 427	Seoul
Korea, Republic of	Local Institution - 430	Seoul
Korea, Republic of	Local Institution - 433	Seoul
Korea, Republic of	Local Institution - 439	Seoul
Korea, Republic of	Local Institution - 440	Seoul
Korea, Republic of	Local Institution - 442	Seoul
Latvia	Local Institution - 600	Riga
Latvia	Local Institution - 601	Riga
Latvia	Local Institution - 602	Riga
Mexico	Local Institution - 528	Chihuahua
Mexico	Local Institution - 450	Ciudad de Mexico	Distrito Federal
Mexico	Centro de Investigacion Clinica Acelerada (CICA) S.C.	Mexico
Mexico	Clinica Omega S.C.	Mexico City
Mexico	Accelerium Clinicla Research	Monterrey	Nuevo León
Mexico	Local Institution - 449	Monterrey	Nuevo León
Mexico	Local Institution - 525	Monterrey	Nuevo León
Mexico	Local Institution - 532	Monterrey	Nuevo León
Mexico	Local Institution - 529	Santiago de Queretaro	Querétaro
Mexico	Local Institution - 530	Tlalpan
Mexico	Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.	Zapapan	Jalisco
Moldova, Republic of	Local Institution - 809	Chisinau
Moldova, Republic of	Local Institution - 810	Chisinau
Moldova, Republic of	Local Institution - 811	Chisinau
Moldova, Republic of	Local Institution - 812	Chisinau
Moldova, Republic of	Local Institution - 813	Chisinau
Poland	Local Institution - 820	Bialystok
Poland	Local Institution - 818	Bochnia
Poland	Local Institution - 819	Katowice
Poland	Local Institution - 828	Katowice
Poland	Synexus Polska Sp. z o.o. Branch in Katowice	Katowice
Poland	Local Institution - 817	Klodzko
Poland	Local Institution - 815	Krakow
Poland	Local Institution - 823	Krakow
Poland	Local Institution - 826	Krakow
Poland	Local Institution - 829	Lodz
Poland	Local Institution - 888	Lodz
Poland	Local Institution - 760	Lublin
Poland	Local Institution - 830	Olsztyn
Poland	Local Institution - 402	Opole
Poland	Local Institution - 400	Oswiecim
Poland	Local Institution - 401	Poznan
Poland	Local Institution - 575	Poznan
Poland	Local Institution - 758	Poznan
Poland	Dariusz Kleczkowski Specialist Medical Practice	Sopot
Poland	TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC	Szczecin
Poland	Local Institution - 822	Torun
Poland	Local Institution - 824	Tychy
Poland	Local Institution - 827	Ul. Piotrkowska 177
Poland	Local Institution - 236	Warsaw
Poland	Local Institution - 410	Warsaw
Poland	Local Institution - 576	Warszawa
Poland	Local Institution - 825	Warszawa
Poland	ETG Zamosc - PPDS	Zamosc	Lubelskie
Poland	Local Institution - 403	Zamosc	Lubelskie
Romania	Center of Diagnosis and Treatment Provita	Bucharest
Romania	Dr. Carol Davila Central Military Emergency Clinical Hospital	Bucharest
Romania	Local Institution - 808	Bucharest
Romania	Local Institution - 836	Bucharest
Romania	Local Institution - 837	Bucharest
Romania	Local Institution - 839	Bucharest
Romania	Monza Oncology Hospital SRL, Department of Gastroenterology	Bucharest
Romania	Local Institution - 843	Craiova
Romania	Colentina Clinical Hospital	Napoca
Romania	Local Institution - 840	Targu Mures
Russian Federation	Local Institution - 598	Chita
Russian Federation	Local Institution - 848	Irkutsk
Russian Federation	Local Institution - 892	Kazan
Russian Federation	Local Institution - 599	Khanty-mansiysk
Russian Federation	Local Institution - 927	Krasnoyarsk
Russian Federation	Local Institution - 851	Moscow
Russian Federation	Local Institution - 594	Novosibirsk
Russian Federation	Local Institution - 858	Petrozavodsk
Russian Federation	Local Institution - 859	Pushkin
Russian Federation	Local Institution - 846	Pyatigorsk
Russian Federation	Local Institution - 960	Pyatigorsk
Russian Federation	Local Institution - 883	Rostov-on-Don
Russian Federation	Local Institution - 847	Saint Petersburg
Russian Federation	Local Institution - 844	Samara
Russian Federation	Local Institution - 862	St Petersburg
Russian Federation	Local Institution - 845	St. Petersburg
Russian Federation	Local Institution - 856	St. Petersburg
Russian Federation	Local Institution - 857	St. Petersburg
Russian Federation	Local Institution - 948	Surgut
Russian Federation	Local Institution - 806	Tula
Russian Federation	Local Institution - 861	Ufa
Russian Federation	Local Institution - 642	Ulyanovsk
Russian Federation	Local Institution - 855	Veliky Novgorod
Russian Federation	Local Institution - 935	Vladimir
Russian Federation	Local Institution - 986	Vladivostok
Russian Federation	Local Institution - 999	Vladivostok
Saudi Arabia	Local Institution - 534	Dammam
Saudi Arabia	King Abdul Aziz University Hospital	Jeddah
Saudi Arabia	King Saud Medical Complex	Riyadh
Saudi Arabia	Local Institution - 535	Riyadh
Serbia	Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Zvezdara University Medical Center	Belgrade
Spain	Local Institution - 703	Alicante
Spain	Local Institution - 690	Badalona
Spain	Local Institution - 698	La Laguna
Spain	Local Institution - 691	Madrid
Spain	Local Institution - 692	Madrid
Spain	Local Institution - 696	Sevilla
Spain	Local Institution - 705	Sevilla
Spain	Local Institution - 700	Viladecans
Switzerland	Local Institution - 967	Bern
Switzerland	Local Institution - 968	St.Gallen
Switzerland	Local Institution - 969	Zurich
Taiwan	Local Institution - 363	Kozlu
Turkey	Local Institution - 356	Ankara
Turkey	Local Institution - 360	Bursa
Turkey	Bezmialem Foundation University Medical Faculty	Istanbul
Turkey	Local Institution - 355	Istanbul
Turkey	Kocaeli University Medical Faculty	Izmit/Kocaeli
Turkey	Local Institution - 367	Mersin
Turkey	Local Institution - 359	Trabzon
Ukraine	Local Institution - 914	Chernivtsi
Ukraine	Local Institution - 950	Dnipropetrovsk
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk
Ukraine	Local Institution - 912	Ivano-Frankivsk
Ukraine	Local Institution - 919	Kharkiv
Ukraine	Limited Liability Company Edelweiss Medics	Kyiv
Ukraine	Local Institution - 562	Kyiv
Ukraine	Local Institution - 901	Kyiv
Ukraine	Local Institution - 908	Kyiv
Ukraine	Local Institution - 911	Kyiv
Ukraine	Local Institution - 915	Kyiv
Ukraine	Local Institution - 918	Kyiv
Ukraine	Medical Center within the Medical Scientific and Practical Association Medbud	Kyiv
Ukraine	Volyn Regional Clinical Hospital	Lutsk
Ukraine	Local Institution - 910	Lviv
Ukraine	Lviv Regional Clinical Hospital	Lviv
Ukraine	Odesa Regional Clinical Hospital	Odesa
Ukraine	Local Institution - 905	Poltava
Ukraine	Local Institution - 934	Ternopil
Ukraine	Local Institution - 909	Vinnytsia
Ukraine	Local Institution - 971	Vinnytsia
Ukraine	National Pirogov Memorial Medical University	Vinnytsia
United Kingdom	Synexus Midlands Clinical Research Centre	Birmingham
United Kingdom	Local Institution - 714	Bristol
United Kingdom	Local Institution - 560	Cardiff
United Kingdom	Synexus Lancashire Clinical Research Centre	Chorley
United Kingdom	Synexus Hexham Clinical Research Centre	Corbridge Road
United Kingdom	Local Institution - 712	Dundonald
United Kingdom	Local Institution - 713	Glasgow
United Kingdom	Local Institution - 716	Lancashire Blackpool
United Kingdom	Local Institution - 715	London
United Kingdom	Local Institution - 722	London
United Kingdom	Local Institution - 729	London	LND
United Kingdom	Local Institution - 561	North Manchester Science Park
United Kingdom	Local Institution - 721	Oxford
United Kingdom	Local Institution - 593	Shrewsbury
United Kingdom	Local Institution - 723	Southampton	Hampshire
United Kingdom	Local Institution - 718	Torquay
United States	Local Institution - 017	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates, Llc	Atlanta	Georgia
United States	Local Institution - 063	Atlanta	Georgia
United States	Local Institution - 205	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia
United States	Local Institution - 158	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Local Institution - 210	Beachwood	Ohio
United States	Connecticut Clinical Research Institute	Bristol	Connecticut
United States	Advantage Clinical Trials	Bronx	New York
United States	Local Institution - 144	Brooklyn	New York
United States	Om Research, LLC	Camarillo	California
United States	Local Institution - 191	Caro	Michigan
United States	Local Institution - 129	Catonsville	Maryland
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Local Institution - 055	Charlotte	North Carolina
United States	Local Institution - 152	Charlotte	North Carolina
United States	Brigham and Women's Hospital - Crohn's and Colitis Center	Chestnut Hill	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center - University Cardiovascular Surgeons	Chicago	Illinois
United States	Local Institution - 165	Chula Vista	California
United States	Local Institution - 291	Cincinnati	Ohio
United States	Local Institution - 062	Clearwater	Florida
United States	Local Institution - 018	Cleveland	Ohio
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	Local Institution - 074	Columbus	Georgia
United States	Local Institution - 215	Englewood	New Jersey
United States	Local Institution - 189	Gainesville	Virginia
United States	University of Florida Health Endocrinology - Medical Specialties - Medical Plaza	Gainesville	Florida
United States	Local Institution - 039	Garden Grove	California
United States	Woodholme Gastroenterology Associates	Glen Burnie	Maryland
United States	Aurora Health Care Aurora Research	Grafton	Wisconsin
United States	Northwell Health	Great Neck	New York
United States	Carolina Research Center	Greenville	North Carolina
United States	Local Institution - 197	Hershey	Pennsylvania
United States	Harmony Medical Research Institute	Hialeah	Florida
United States	Local Institution - 078	Hialeah	Florida
United States	Local Institution - 203	Hialeah	Florida
United States	Local Institution - 179	Hollywood	Florida
United States	Local Institution - 101	Homestead	Florida
United States	CroNOLA LLC	Houma	Louisiana
United States	Houston Methodist Hospital	Houston	Texas
United States	Local Institution - 082	Houston	Texas
United States	Local Institution - 088	Houston	Texas
United States	Local Institution - 102	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Local Institution - 274	Jackson	Mississippi
United States	San Diego Clinical Trials	La Mesa	California
United States	Local Institution - 053	Lake Charles	Louisiana
United States	Topography Health	Lakewood	Colorado
United States	Local Institution - 016	Largo	Florida
United States	University Of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Local Institution - 061	Los Angeles	California
United States	Local Institution - 110	Los Angeles	California
United States	Local Institution - 028	Macon	Georgia
United States	Gastroenterology Associates P.C.	Manassas	Virginia
United States	Local Institution - 209	Mather	California
United States	Local Institution - 177	Mentor	Ohio
United States	LCC Medical Research Institute, LLC	Miami	Florida
United States	Local Institution - 199	Miami	Florida
United States	Research Associates of South Florida LLC	Miami	Florida
United States	Local Institution - 140	Mission Viejo	California
United States	Local Institution - 090	Naples	Florida
United States	Local Institution - 121	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Local Institution - 091	New Haven	Connecticut
United States	Local Institution - 104	New Orleans	Louisiana
United States	NSB Research	New Smyrna Beach	Florida
United States	Cornell University	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Local Institution - 026	North Little Rock	Arkansas
United States	University of Massachusetts Memorial Medical Center	North Worcester	Massachusetts
United States	Alliance Clinical Research	Oceanside	California
United States	Digestive Disease Specialists	Oklahoma City	Oklahoma
United States	Local Institution - 208	Oklahoma City	Oklahoma
United States	Clinnova	Orange	California
United States	Local Institution - 094	Orchard Park	New York
United States	Local Institution - 076	Orlando	Florida
United States	Palo Alto Center-Palo Alto Medical Foundation Research Institute	Palo Alto	California
United States	Holland Center for Family Health	Peoria	Arizona
United States	Local Institution - 139	Petersburg	Virginia
United States	Local Institution - 098	Port Orange	Florida
United States	Local Institution - 113	Portland	Oregon
United States	Local Institution - 16	Princeton	New Jersey
United States	Local Institution - 19	Princeton	New Jersey
United States	Local Institution - 25	Princeton	New Jersey
United States	Local Institution - 26	Princeton	New Jersey
United States	Local Institution - 28	Princeton	New Jersey
United States	Local Institution - 29	Princeton	New Jersey
United States	Local Institution - 3	Princeton	New Jersey
United States	Local Institution - 36	Princeton	New Jersey
United States	Local Institution - 39	Princeton	New Jersey
United States	Local Institution - 43	Princeton	New Jersey
United States	Local Institution - 55	Princeton	New Jersey
United States	Local Institution - 56	Princeton	New Jersey
United States	Local Institution - 6	Princeton	New Jersey
United States	Local Institution - 61	Princeton	New Jersey
United States	Local Institution - 62	Princeton	New Jersey
United States	Local Institution - 63	Princeton	New Jersey
United States	Local Institution - 7	Princeton	New Jersey
United States	Local Institution - 73	Princeton	New Jersey
United States	Local Institution - 74	Princeton	New Jersey
United States	Local Institution - 76	Princeton	New Jersey
United States	Local Institution - 85	Princeton	New Jersey
United States	Local Institution - 9	Princeton	New Jersey
United States	Local Institution - 91	Princeton	New Jersey
United States	Local Institution - 98	Princeton	New Jersey
United States	University of Gastroenterology	Providence	Rhode Island
United States	M3 Wake Research Inc	Raleigh	North Carolina
United States	Local Institution - 006	Rialto	California
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	University Of Utah School Of Medicine	Salt Lake City	Utah
United States	Southern Star Research Institute LLC	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Medical Associates Research Group	San Diego	California
United States	University Of Washington Medical Center	Seattle	Washington
United States	Local Institution - 108	Southfield	Michigan
United States	Texas Digestive Disease Consultants - Southlake	Southlake	Texas
United States	Local Institution - 125	Spokane	Washington
United States	Local Institution - 286	Springfield	Massachusetts
United States	Penn State University Milton S Hershey Medical Center	State College	Pennsylvania
United States	Virginia Gastroenterology Institute PC	Suffolk	Virginia
United States	International Center for Research	Tampa	Florida
United States	USF Health	Tampa	Florida
United States	Local Institution - 073	Tyler	Texas
United States	Advanced Gastroenterology	Union City	Tennessee
United States	Local Institution - 146	Urbana	Illinois
United States	Local Institution - 211	Warren	Ohio
United States	Local Institution - 114	Weeki Wachee	Florida
United States	TPMG Clinical Research	Williamsburg	Virginia
United States	West Michigan Clinical Research Center	Wyoming	Michigan
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  Denmark,  Finland,  France,  Georgia,  Germany,  India,  Ireland,  Israel,  Italy,  Korea, Republic of,  Latvia,  Mexico,  Moldova, Republic of,  Poland,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150		Week 12
Secondary	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		Week 12
Secondary	Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50%		Week 12
Secondary	Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150		Week 12
Secondary	Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 and SES-CD decrease from baseline of = 50%		Week 12
Secondary	Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of = 50%		Week 12
Secondary	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		Week 12
Secondary	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%		Week 12
Secondary	Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes)		Week 12
Secondary	Proportion of participants with CDAI reduction from baseline of = 70 points		Week 12
Secondary	Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%		Week 12
Secondary	Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%		Week 12

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting