Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440385
• Other study ID #: RPC01-3202
• Secondary ID: U1111-1203-79492
• Status: Completed
• Phase: Phase 3
• Start date: March 7, 2018
• Est. completion date: November 21, 2023

Study information

• Verified date: December 2023
• Source: Celgene
• Contact: n/a
• 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: Completed
• Enrollment: 606
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 therapy

• Crohn's Disease Activity Index (CDAI) score = 220 and = 450

• Average daily stool frequency = 4 points and/or an abdominal pain of = 2 points

• Simple Endoscopic Score for Crohn's Disease (SES-CD) score of = 6 (or SES-CD = 4 in participants with isolated ileal disease)

Exclusion Criteria:

• Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention

• Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition

• Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply

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
Australia	Local Institution - 307	Bedford Park	South Australia
Australia	Local Institution - 317	Clayton	Victoria
Australia	Local Institution - 326	Elizabeth Vale	South Australia
Australia	Local Institution - 305	Fitzroy	Victoria
Australia	Local Institution - 329	Geelong	Victoria
Australia	Local Institution - 328	Herston	Queensland
Australia	Local Institution - 309	Liverpool	New South Wales
Australia	Local Institution - 313	Maroorchydore	Queensland
Australia	Local Institution - 327	Melbourne	Victoria
Australia	Local Institution - 318	New Lambton Heights	New South Wales
Australia	Local Institution - 321	North Mackay	Queensland
Australia	Local Institution - 312	South Brisbane	Queensland
Australia	Local Institution - 315	Subiaco	Western Australia
Austria	Local Institution - 726	Innsbruck
Austria	Local Institution - 727	St Polten
Austria	Local Institution - 336	Vienna
Austria	Local Institution - 725	Vienna
Bulgaria	Local Institution - 753	Ruse
Bulgaria	Local Institution - 554	Sofia
Bulgaria	Local Institution - 750	Sofia
Bulgaria	Local Institution - 752	Sofia
Bulgaria	Local Institution - 755	Sofia
Bulgaria	Local Institution - 756	Sofia
Canada	Local Institution - 256	Brandon	Manitoba
Canada	Local Institution - 269	Edmonton	Alberta
Canada	Local Institution - 254	Montreal	Quebec
Canada	Local Institution - 262	New Westminister	British Columbia
Canada	Local Institution - 270	Ottawa	Quebec
Canada	Local Institution - 266	Sudbury	Ontario
Canada	Local Institution - 257	Toronto	Ontario
Canada	Local Institution - 264	Toronto	Ontario
Canada	Local Institution - 267	Vancouver	British Columbia
China	Local Institution - 467	Beijing
China	Local Institution - 482	Beijing
China	Local Institution - 379	Bengbu
China	Local Institution - 376	Changchun
China	Local Institution - 485	Changchun
China	Local Institution - 378	Changsha
China	Local Institution - 421	Changsha
China	Local Institution - 414	Changzhou
China	Local Institution - 423	Changzhou City	Jiangsu
China	Local Institution - 419	Chengdu
China	Local Institution - 422	Fuzhou
China	Local Institution - 478	Guangzhou
China	Local Institution - 472	Guangzhou Shi
China	Local Institution - 486	Guangzhou Shi
China	Local Institution - 470	Hangzhou, Zhejiang
China	Local Institution - 491	Hefei
China	Local Institution - 374	Kunming
China	Local Institution - 383	Luzhou
China	Local Institution - 488	Nanchang
China	Local Institution - 375	Nanjing
China	Local Institution - 487	Nanjing
China	Local Institution - 418	Nanjing City
China	Local Institution - 369	Shanghai	Shanghai
China	Local Institution - 377	Shanghai
China	Local Institution - 380	Shanghai
China	Local Institution - 473	Shanghai
China	Local Institution - 458	Taichung City
China	Local Institution - 373	Tianjin
China	Local Institution - 474	Wuhan
China	Local Institution - 475	Wuhan
China	Local Institution - 483	Wuhan Shi
China	Local Institution - 381	Wuxi
China	Local Institution - 415	Xi'an
China	Local Institution - 420	Xi'an
China	Local Institution - 370	Zhengzhou
Colombia	Local Institution - 397	Armenia
Colombia	Local Institution - 398	Barranquilla
Colombia	Local Institution - 395	Bogota
Colombia	Local Institution - 396	Cali
Colombia	Local Institution - 394	Medellin
Finland	Local Institution - 613	Helsinki
France	Local Institution - 639	Béziers
France	Local Institution - 635	Blois Cedex
France	Local Institution - 634	Caen
France	Local Institution - 644	Colombes
France	Local Institution - 632	Nantes
France	Local Institution - 647	Neuilly-sur-Seine	Cedex
France	Local Institution - 630	Pierre-Benite
France	Local Institution - 631	Saint Priest en Jarez
Georgia	Local Institution - 786	Batumi
Georgia	Local Institution - 779	Kutaisi
Georgia	Local Institution - 335	Tbilisi
Georgia	Local Institution - 454	Tbilisi
Georgia	Local Institution - 455	Tbilisi
Georgia	Local Institution - 552	Tbilisi
Georgia	Local Institution - 740	Tbilisi
Georgia	Local Institution - 778	Tbilisi
Georgia	Local Institution - 781	Tbilisi
Georgia	Local Institution - 782	Tbilisi
Georgia	Local Institution - 783	Tbilisi
Georgia	Local Institution - 784	Tbilisi
Georgia	Local Institution - 785	Tbilisi
Georgia	Local Institution - 793	Tbilisi
Georgia	Local Institution - 780	Telavi
Germany	Local Institution - 628	Berlin
Germany	Local Institution - 629	Berlin
Germany	Local Institution - 648	Berlin
Germany	Local Institution - 653	Berlin
Germany	Local Institution - 664	Brandenburg an der Havel
Germany	Local Institution - 732	Dachau
Germany	Local Institution - 574	Frankfurt am Main
Germany	Local Institution - 657	Frankfurt am Main
Germany	Local Institution - 656	Halle
Germany	Local Institution - 658	Halle
Germany	Local Institution - 652	Hamburg
Germany	Local Institution - 591	Hannover
Germany	Local Institution - 649	Keil
Germany	Local Institution - 337	Leipzig
Germany	Local Institution - 660	Mainz
Germany	Local Institution - 667	Muenster
Germany	Local Institution - 620	Neuruppin
Germany	Local Institution - 584	Nuertingen
Germany	Local Institution - 661	Stuttgart
Greece	Local Institution - 588	Athens
Greece	Local Institution - 790	Athens
Greece	Local Institution - 791	Athens
Greece	Local Institution - 792	Athens
Greece	Local Institution - 592	Athens, Attiki
Greece	Local Institution - 787	Heraklion
Greece	Local Institution - 788	Thessaloniki
Greece	Local Institution - 789	Thessaloniki
Hong Kong	Local Institution - 404	Hong Kong
Hong Kong	Local Institution - 405	Kowloon
Hong Kong	Local Institution - 406	Sha Tin
Hungary	Local Institution - 798	Bekescsaba
Hungary	Local Institution - 556	Budapest
Hungary	Local Institution - 803	Budapest
Hungary	Local Institution - 804	Budapest
Hungary	Local Institution - 801	Gyor
Hungary	Local Institution - 555	Gyula
Hungary	Local Institution - 797	Miskolc
Hungary	Local Institution - 800	Nagykanizsa
Hungary	Local Institution - 799	Szekesfehervar
Hungary	Local Institution - 816	Szekszárd
Hungary	Local Institution - 805	Szentes
Israel	Local Institution - 343	Afula
Israel	Local Institution - 346	Beer Jacob
Israel	Local Institution - 350	Haifa
Israel	Local Institution - 347	Jerusalem
Israel	Local Institution - 349	Kfar-Saba
Israel	Local Institution - 341	Petah Tikva
Israel	Local Institution - 340	Tel-Aviv
Korea, Republic of	Local Institution - 431	Busan
Korea, Republic of	Local Institution - 434	Busan
Korea, Republic of	Local Institution - 432	Daegu
Korea, Republic of	Local Institution - 438	Seoul
Korea, Republic of	Local Institution - 429	Suwon
Lithuania	Local Institution - 605	Kaunas
Lithuania	Local Institution - 603	Klaipeda
Lithuania	Local Institution - 604	Vilnius
Lithuania	Local Institution - 606	Vilnius
Lithuania	Local Institution - 607	Vilnius
Netherlands	Local Institution - 952	Amsterdam
Netherlands	Local Institution - 955	Amsterdam
Netherlands	Local Institution - 956	Groningen
Netherlands	Local Institution - 949	Nijmegen
Netherlands	Local Institution - 951	Sittard-Geleen
Netherlands	Local Institution - 954	Tilburg
Poland	Local Institution - 580	Czestochowa
Poland	Local Institution - 988	Elblag
Poland	Local Institution - 579	Gdansk
Poland	Local Institution - 978	Gdansk
Poland	Local Institution - 577	Gdynia
Poland	Local Institution - 906	Jelenia Gora
Poland	Local Institution - 757	Jozefow
Poland	Local Institution - 578	Katowice
Poland	Local Institution - 834	Ksawerow
Poland	Local Institution - 581	Lodz
Poland	Local Institution - 981	Lodz
Poland	Local Institution - 976	Nowy Targ
Poland	Local Institution - 963	Rzeszow
Poland	Local Institution - 979	Sopot
Poland	Local Institution - 835	Szczecin
Poland	Local Institution - 586	Warsaw
Poland	Local Institution - 807	Warsaw
Poland	Local Institution - 833	Warsaw
Poland	Local Institution - 989	Warszawa
Poland	Local Institution - 893	Wierzchoslawice
Poland	Local Institution - 582	Wroclaw
Poland	Local Institution - 831	Wroclaw
Poland	Local Institution - 832	Wroclaw
Poland	Local Institution - 982	Wroclaw
Poland	Local Institution - 983	Wroclaw
Poland	Local Institution - 984	Wroclaw
Poland	Local Institution - 987	Wroclaw
Portugal	Local Institution - 959	Coimbra
Portugal	Local Institution - 958	Guimaraes
Portugal	Local Institution - 961	Loures
Portugal	Local Institution - 957	Viana do Castelo
Russian Federation	Local Institution - 871	Barnaul
Russian Federation	Local Institution - 966	Barnaul
Russian Federation	Local Institution - 589	Bataisk
Russian Federation	Local Institution - 621	Chelyabinsk
Russian Federation	Local Institution - 991	Chelyabinsk
Russian Federation	Local Institution - 583	Ekaterinburg
Russian Federation	Local Institution - 872	Ekaterinburg
Russian Federation	Local Institution - 998	Kaliningrad
Russian Federation	Local Institution - 882	Kaluga
Russian Federation	Local Institution - 849	Kemerovo
Russian Federation	Local Institution - 566	Moscow
Russian Federation	Local Institution - 869	Moscow
Russian Federation	Local Institution - 870	Moscow
Russian Federation	Local Institution - 873	Moscow
Russian Federation	Local Institution - 995	Moscow
Russian Federation	Local Institution - 990	Nizhny Novgorod
Russian Federation	Local Institution - 853	Novosibirsk
Russian Federation	Local Institution - 876	Novosibirsk
Russian Federation	Local Institution - 996	Omsk
Russian Federation	Local Institution - 875	Orenburg
Russian Federation	Local Institution - 867	Penza
Russian Federation	Local Institution - 874	Saint Petersburg
Russian Federation	Local Institution - 868	Saint-Petersburg
Russian Federation	Local Institution - 865	Samara
Russian Federation	Local Institution - 992	Saratov
Russian Federation	Local Institution - 866	Sochi
Russian Federation	Local Institution - 878	St Petersburg
Russian Federation	Local Institution - 857	St. Petersburg
Russian Federation	Local Institution - 863	St. Petersburg
Russian Federation	Local Institution - 879	St. Petersburg
Russian Federation	Local Institution - 993	St. Petersburg
Russian Federation	Local Institution - 877	Tomsk
Russian Federation	Local Institution - 881	Ufa
Russian Federation	Local Institution - 880	Volgograd
Senegal	Local Institution - 546	Cape Town
Serbia	Local Institution - 596	Belgrade
Serbia	Local Institution - 886	Belgrade
Serbia	Local Institution - 887	Belgrade
Serbia	Local Institution - 890	Belgrade
Serbia	Local Institution - 891	Kragujevac
Serbia	Local Institution - 884	Novi Sad
Serbia	Local Institution - 885	Pancevo
Serbia	Local Institution - 585	Vrsac
Serbia	Local Institution - 889	Zrenjanin
Slovakia	Local Institution - 894	Bratislava
Slovakia	Local Institution - 900	Bratislava
Slovakia	Local Institution - 895	Brezno
Slovakia	Local Institution - 899	Nitra
Slovakia	Local Institution - 897	Nove Zamky
Slovakia	Local Institution - 898	Presov
Slovakia	Local Institution - 896	Rimavska Sobota
Slovenia	Local Institution - 904	Celje
South Africa	Local Institution - 543	Gauteng
South Africa	Local Institution - 545	Kempton Park
South Africa	Local Institution - 542	Pretoria
South Africa	Local Institution - 544	Pretoria
South Africa	Local Institution - 549	Pretoria
South Africa	Local Institution - 548	Somerset West
South Africa	Local Institution - 547	Val De Grace
Spain	Teknon Medical Center	Barcelona
Spain	University Hospital Reina Sofia	Cordoba
Spain	University Hospital of Girona Dr. Josep Trueta	Girona
Spain	Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria
Spain	Local Institution - 695	Madrid
Spain	University Hospital Puerta de Hierro Majadajonda	Majadahonda, Madrid
Spain	University Hospital Marques de Valdecilla (HUMV)	Santander
Spain	Local Institution - 697	Valencia
Sweden	Local Institution - 625	Stockholm
Taiwan	Local Institution - 460	Kaohsiung
Taiwan	Local Institution - 463	Kaohsiung, San Ming Dist.
Taiwan	Local Institution - 461	Niao-Sung Hsiang Kaohsiung County
Taiwan	Local Institution - 459	Tainan, Taiana
Taiwan	Local Institution - 462	Taoyuan City
Taiwan	Local Institution - 465	Tapei
Taiwan	Local Institution - 464	Tapei, Beitou Dist.
Turkey	Local Institution - 357	Ankara
Turkey	Local Institution - 365	Elazig
Turkey	Local Institution - 358	Istanbul
Turkey	Local Institution - 361	Istanbul
Turkey	Local Institution - 353	Kadiköy/Istanbul
Ukraine	Local Institution - 922	Chernivtsi
Ukraine	Local Institution - 929	Ivano-Frankivsk
Ukraine	Local Institution - 965	Kharkiv
Ukraine	Local Institution - 920	Khmelnytskyi
Ukraine	Local Institution - 933	Kropyvnytskyi
Ukraine	Local Institution - 563	Kyiv
Ukraine	Local Institution - 564	Kyiv
Ukraine	Local Institution - 923	Kyiv
Ukraine	Local Institution - 977	Kyiv
Ukraine	Local Institution - 590	Lutsk
Ukraine	Local Institution - 974	Lviv
Ukraine	Local Institution - 902	Odesa
Ukraine	Local Institution - 924	Vinnytsia
Ukraine	Local Institution - 932	Vinnytsya
Ukraine	Local Institution - 587	Zaporizhia
Ukraine	Local Institution - 925	Zaporizhzhya
United States	Local Institution - 037	Atlanta	Georgia
United States	Local Institution - 220	Atlanta	Georgia
United States	Local Institution - 020	Baton Rouge	Louisiana
United States	Local Institution - 182	Bristol	Connecticut
United States	Local Institution - 156	Charlotte	North Carolina
United States	Local Institution - 022	Chicago	Illinois
United States	Local Institution - 166	Clearwater	Florida
United States	Local Institution - 084	Clermont	Florida
United States	Local Institution - 065	Colorado Springs	Colorado
United States	American Research Institute Inc	Cutler Bay	Florida
United States	Local Institution - 170	Dayton	Ohio
United States	Local Institution - 143	Decatur	Georgia
United States	Local Institution - 112	Doral	Florida
United States	Riverside Clinical Research	Edgewater	Florida
United States	Local Institution - 092	Evansville	Indiana
United States	Local Institution - 034	Fort Sam Houston	Texas
United States	Local Institution - 054	Hartsdale	New York
United States	Local Institution - 049	Hilliard	Ohio
United States	Gulf Coast Research Group LLC	Houston	Texas
United States	Local Institution - 079	Houston	Texas
United States	Local Institution - 196	Houston	Texas
United States	Local Institution - 115	Idaho Falls	Idaho
United States	Local Institution - 033	Indianapolis	Indiana
United States	Local Institution - 167	Kalamazoo	Michigan
United States	Local Institution - 198	Kansas City	Missouri
United States	SIH Research	Kissimmee	Florida
United States	Local Institution - 089	La Crosse	Wisconsin
United States	Ucsd Medical Center	La Jolla	California
United States	Clinical Trials of SW Louisiana LLC	Lake Charles	Louisiana
United States	Local Institution - 010	Lancaster	California
United States	Internal Medicine Specialists	Las Vegas	Nevada
United States	Local Institution - 040	Lebanon	New Hampshire
United States	Local Institution - 067	Lighthouse Point	Florida
United States	Matrix Clinical Research Inc	Los Angeles	California
United States	Southern California Research Institute Medical Group, Inc.	Los Angeles	California
United States	Local Institution - 030	Lynchburg	Virginia
United States	Center For Advanced Gastroenterology	Maitland	Florida
United States	Tandem Clinical Research, LLC	Marrero	Louisiana
United States	LMG Research	Miami	Florida
United States	Local Institution - 081	Miami	Florida
United States	Local Institution - 175	Miami	Florida
United States	Local Institution - 044	Miami Springs	Florida
United States	Paramount Medical Research & Consulting, Llc	Middleburg Heights	Ohio
United States	Local Institution - 095	Minneapolis	Minnesota
United States	Facey Medical Foundation (Parent)	Mission Hills	California
United States	Local Institution - 192	New Port Richey	Florida
United States	Concorde Medical Group	New York	New York
United States	TrialSpark	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Local Institution - 087	Norman	Oklahoma
United States	Local Institution - 060	North Massapequa	New York
United States	Local Institution - 005	Novi	Michigan
United States	Local Institution - 294	Oklahoma City	Oklahoma
United States	Local Institution - 200	Orlando	Florida
United States	Local Institution - 002	Palmetto Bay	Florida
United States	Accurate Clinical Research Inc	Pasadena	Texas
United States	Local Institution - 093	Pasadena	California
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Theia Clinical Research, LLC	Pinellas Park	Florida
United States	The Gastroenterology Group	Reston	Virginia
United States	Local Institution - 071	Richardson	Texas
United States	Local Institution - 072	Richmond	Virginia
United States	Local Institution - 292	Riverton	Utah
United States	Local Institution - 172	Roanoke	Virginia
United States	Local Institution - 045	Rochester	Minnesota
United States	Sutter Medical Group	Roseville	California
United States	Local Institution - 280	Sacramento	California
United States	Local Institution - 178	San Antonio	Texas
United States	Local Institution - 281	San Francisco	California
United States	Local Institution - 202	Scottsdale	Arizona
United States	Precision Clinical Research, LLC.	Sunrise	Florida
United States	Apex Clinical Research	Tampa	Florida
United States	Local Institution - 107	Tampa	Florida
United States	Local Institution - 183	Tampa	Florida
United States	Local Institution - 181	Temple	Texas
United States	Local Institution - 070	Topeka	Kansas
United States	Local Institution - 185	Tulsa	Oklahoma
United States	Local Institution - 217	Tulsa	Oklahoma
United States	Local Institution - 124	West Covina	California
United States	Local Institution - 052	Winston-Salem	North Carolina
United States	Local Institution - 024	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Bulgaria,  Canada,  China,  Colombia,  Finland,  France,  Georgia,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Korea, Republic of,  Lithuania,  Netherlands,  Poland,  Portugal,  Russian Federation,  Senegal,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine, 

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 with SES-CD decrease from baseline of = 50%		Week 12
Secondary	Proportion of participants with CDAI score < 150 with 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	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%	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 using the Global Histologic Disease Activity Score		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