Clinical trial NCT03464097: A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn's Disease
Crohn Disease
Oral
Ozanimod
Moderately active
Severely active
RPC01
RPC01-3203
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-03-13
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

* Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
* In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study

Exclusion Criteria:

* Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
* Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Proportion of participants with Crohn's Disease Activity Index (CDAI) score < 150
timeFrame: Week 52
measure: Proportion of participants with Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline ≥ 50%
timeFrame: Week 52
Secondary outcomes:
measure: Proportion of participants with CDAI reduction from baseline ≥ 100 points or CDAI score < 150
timeFrame: Week 52
measure: Proportion of participants with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline
timeFrame: Week 52
measure: Proportion of participants with CDAI score < 150 at Week 52, while remaining corticosteroid-free in the 12 weeks prior to Week 52 among all participants at Maintenance Day 1
timeFrame: Week 52
measure: Proportion of participants with CDAI score < 150 in participants with CDAI score < 150 at Maintenance Day 1
timeFrame: Week 52
measure: Proportion of participants with Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 points and SES-CD decrease from baseline ≥ 2 points with no SES-CD subscore > 1 point
timeFrame: Week 52
measure: Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline ≥ 50%
timeFrame: Week 52
measure: Proportion of participants with ADAPS ≤1 point, and average daily stool frequency score ≤3 points with abdominal pain and stool frequency no worse than baseline and SES-CD ≤4 points and SES-CD decrease ≥2 points with no SES-CD subscore >1 point
timeFrame: Week 52
measure: Proportion of participants with CDAI reduction from baseline ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline ≥ 50%
timeFrame: Week 52
measure: Proportion of participants with CDAI score < 150 at Maintenance Day 1 and SES-CD decrease from baseline ≥50%
timeFrame: Week 52
measure: Proportion of participants with CDAI reduction from baseline ≥ 70 points
timeFrame: Week 52
measure: Proportion of participants with CDAI score < 150, while remaining corticosteroid free in the 12 weeks prior to Week 52 among participants using corticosteroids at Maintenance Day 1
timeFrame: Week 52
measure: Proportion of participants with mucosal healing (SES-CD ≤ 4 points and SES-CD decrease ≥ 2 points with no SES-CD subscore > 1 point) and histologic improvement based on Robarts Histologic Index
timeFrame: Week 52
measure: Time to relapse (an increase in CDAI score from Maintenance Day 1 ≥100 points and CDAI score >220, SES-CD ≥6 [or ≥4 if isolated ileal disease]), and exclusion of other causes of an increase in disease activity unrelated to underlying CD
timeFrame: Week 52
measure: Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline ≥ 50%
timeFrame: Week 52
measure: Proportion of participants with CDAI score < 150 and at ≥ 80% of visits between Week 8 and Week 52, inclusive, in participants with CDAI score < 150 at Maintenance Day 1
timeFrame: Week 52
measure: 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 and SES-CD decrease from baseline ≥ 50%
timeFrame: Week 52
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Holland Center for Family Health
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city: Scottsdale
country: United States
facility: Local Institution - 202
state: Arizona
city: North Little Rock
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facility: Local Institution - 026
state: Arkansas
city: Camarillo
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facility: Local Institution - 284
state: California
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facility: Sharp Chula Vista Medical Center
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state: California
city: La Jolla
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facility: Ucsd Medical Center
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facility: San Diego Clinical Trials
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facility: Facey Medical Foundation (Parent)
state: California
city: Mission Viejo
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facility: Alliance Clinical Research
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state: California
city: Palo Alto
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facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute
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facility: Havana Research Institute LLC
state: California
city: Rialto
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state: California
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city: Sacramento
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state: California
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state: California
city: San Francisco
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state: California
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facility: American Research Institute Inc
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facility: Theia Clinical Research, LLC
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city: Port Orange
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state: Florida
city: Sunrise
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facility: Precision Clinical Research, LLC.
state: Florida
city: Tampa
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state: Florida
city: Tampa
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facility: Apex Clinical Research
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state: Florida
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state: Florida
city: Weeki Wachee
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state: Florida
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state: Georgia
city: Atlanta
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state: Georgia
city: Atlanta
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state: Georgia
city: Atlanta
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state: Georgia
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state: Georgia
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state: Idaho
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state: Illinois
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state: Indiana
city: Indianapolis
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state: Indiana
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state: Kansas
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state: Kentucky
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state: Louisiana
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facility: CroNOLA LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Centex Studies, Inc.
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SW Louisiana LLC
state: Louisiana
city: Marrero
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facility: Tandem Clinical Research, LLC
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city: New Orleans
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state: Maryland
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state: Maryland
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state: Maryland
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state: Massachusetts
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state: Massachusetts
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state: Massachusetts
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state: Michigan
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state: Michigan
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state: Michigan
city: Southfield
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state: Michigan
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state: Michigan
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state: Missouri
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state: North Carolina
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state: North Carolina
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state: Ohio
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state: Ohio
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state: Ohio
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facility: Great Lakes Medical Research, LLC
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state: Oklahoma
city: Oklahoma City
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state: Oklahoma
city: Oklahoma City
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state: Oklahoma
city: Oklahoma City
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state: Oklahoma
city: Tulsa
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state: Oklahoma
city: Tulsa
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state: Oklahoma
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state: Oregon
city: Hershey
country: United States
facility: Local Institution - 197
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: State College
country: United States
facility: Penn State University Milton S Hershey Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Local Institution - 253
state: Rhode Island
city: Charleston
country: United States
facility: Local Institution - 289
state: South Carolina
city: Nashville
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state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 158
state: Texas
city: Fort Sam Houston
country: United States
facility: Local Institution - 034
state: Texas
city: Houston
country: United States
facility: Local Institution - 056
state: Texas
city: Houston
country: United States
facility: Local Institution - 150
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc. Research Center
state: Texas
city: Houston
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facility: Centex Studies, Inc.
state: Texas
city: Houston
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facility: GI Specialists of Houston
state: Texas
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state: Texas
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state: Texas
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state: Texas
city: Houston
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country: United States
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state: Utah
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state: Virginia
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country: United States
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state: Virginia
city: Petersburg
country: United States
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country: United States
facility: The Gastroenterology Group
state: Virginia
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country: United States
facility: Local Institution - 072
state: Virginia
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country: United States
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state: Virginia
city: Suffolk
country: United States
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country: United States
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country: United States
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state: Wisconsin
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state: New South Wales
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state: New South Wales
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state: Queensland
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country: Australia
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state: South Australia
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country: Australia
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state: Victoria
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country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Sofia
country: Bulgaria
facility: Local Institution - 750
city: Sofia
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Sofia
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city: Sofia
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city: Sofia
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city: Sofia
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state: Alberta
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state: Alberta
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state: Alberta
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state: British Columbia
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state: British Columbia
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facility: Local Institution - 268
state: Nova Scotia
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facility: Local Institution - 252
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facility: Local Institution - 251
state: Ontario
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facility: Local Institution - 266
state: Ontario
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facility: Local Institution - 264
state: Ontario
city: Toronto
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facility: Local Institution - 257
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city: Vaughan
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country: Chile
facility: Local Institution - 390
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city: Changchun
country: China
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country: China
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city: Guangzhou Shi
country: China
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city: Guangzhou
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city: Nanjing
country: China
facility: Local Institution - 487
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facility: Local Institution - 380
city: Shanghai
country: China
facility: Local Institution - 377
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city: Zagreb
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city: Zagreb
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facility: Local Institution - 768
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country: Czechia
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city: Prague
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facility: Local Institution - 573
city: Prague
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facility: Local Institution - 610
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state: Cedex
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facility: Local Institution - 639
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city: Tbilisi
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facility: Local Institution - 650
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facility: Local Institution - 800
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facility: Local Institution - 688
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facility: Local Institution - 676
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state: Lubelskie
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facility: Local Institution - 824
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city: Tula
country: Russian Federation
facility: Local Institution - 806
city: Ufa
country: Russian Federation
facility: Local Institution - 881
city: Ufa
country: Russian Federation
facility: Local Institution - 861
city: Veliky Novgorod
country: Russian Federation
facility: Local Institution - 855
city: Vladimir
country: Russian Federation
facility: Local Institution - 935
city: Vladivostok
country: Russian Federation
facility: Local Institution - 999
city: Vladivostok
country: Russian Federation
facility: Local Institution - 986
city: Volgograd
country: Russian Federation
facility: Local Institution - 880
city: Dammam
country: Saudi Arabia
facility: Local Institution - 534
city: Jeddah
country: Saudi Arabia
facility: Local Institution - 537
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 536
city: Riyadh
country: Saudi Arabia
facility: Local Institution - 535
city: Cape Town
country: Senegal
facility: Local Institution - 546
city: Belgrade
country: Serbia
facility: Local Institution - 241
city: Belgrade
country: Serbia
facility: Local Institution - 245
city: Belgrade
country: Serbia
facility: Local Institution - 887
city: Belgrade
country: Serbia
facility: Local Institution - 246
city: Belgrade
country: Serbia
facility: Local Institution - 596
city: Belgrade
country: Serbia
facility: Local Institution - 886
city: Belgrade
country: Serbia
facility: Local Institution - 890
city: Kragujevac
country: Serbia
facility: Local Institution - 891
city: Novi Sad
country: Serbia
facility: Local Institution - 884
city: Pancevo
country: Serbia
facility: Local Institution - 885
city: Vrsac
country: Serbia
facility: Local Institution - 585
city: Zrenjanin
country: Serbia
facility: Local Institution - 889
city: Bratislava
country: Slovakia
facility: Local Institution - 900
city: Bratislava
country: Slovakia
facility: Local Institution - 894
city: Brezno
country: Slovakia
facility: Local Institution - 895
city: Nitra
country: Slovakia
facility: Local Institution - 899
city: Nove Zamky
country: Slovakia
facility: Local Institution - 897
city: Presov
country: Slovakia
facility: Local Institution - 898
city: Rimavska Sobota
country: Slovakia
facility: Local Institution - 896
city: Celje
country: Slovenia
facility: Local Institution - 904
city: Gauteng
country: South Africa
facility: Local Institution - 543
city: Kempton Park
country: South Africa
facility: Local Institution - 545
city: Pretoria
country: South Africa
facility: Local Institution - 544
city: Pretoria
country: South Africa
facility: Local Institution - 542
city: Pretoria
country: South Africa
facility: Local Institution - 549
city: Somerset West
country: South Africa
facility: Local Institution - 548
city: Val De Grace
country: South Africa
facility: Local Institution - 547
city: Alicante
country: Spain
facility: Local Institution - 703
city: Badalona
country: Spain
facility: Local Institution - 690
city: Barcelona
country: Spain
facility: Local Institution - 694
city: Cordoba
country: Spain
facility: Local Institution - 702
city: Girona
country: Spain
facility: Local Institution - 699
city: La Laguna
country: Spain
facility: Local Institution - 698
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution - 701
city: Madrid
country: Spain
facility: Local Institution - 691
city: Madrid
country: Spain
facility: Local Institution - 695
city: Madrid
country: Spain
facility: Local Institution - 692
city: Majadahonda, Madrid
country: Spain
facility: Local Institution - 693
city: Santander
country: Spain
facility: Local Institution - 706
city: Sevilla
country: Spain
facility: Local Institution - 696
city: Sevilla
country: Spain
facility: Local Institution - 705
city: Valencia
country: Spain
facility: Local Institution - 697
city: Viladecans
country: Spain
facility: Local Institution - 700
city: Stockholm
country: Sweden
facility: Local Institution - 625
city: Bern
country: Switzerland
facility: Local Institution - 967
city: St.Gallen
country: Switzerland
facility: Local Institution - 968
city: Zurich
country: Switzerland
facility: Local Institution - 969
city: Kaohsiung, San Ming Dist.
country: Taiwan
facility: Local Institution - 463
city: Kaohsiung
country: Taiwan
facility: Local Institution - 460
city: Kozlu
country: Taiwan
facility: Local Institution - 363
city: Niao-Sung Hsiang Kaohsiung County
country: Taiwan
facility: Local Institution - 461
city: Tainan, Taiana
country: Taiwan
facility: Local Institution - 459
city: Taoyuan City
country: Taiwan
facility: Local Institution - 462
city: Tapei, Beitou Dist.
country: Taiwan
facility: Local Institution - 464
city: Tapei
country: Taiwan
facility: Local Institution - 465
city: Ankara
country: Turkey
facility: Local Institution - 357
city: Ankara
country: Turkey
facility: Local Institution - 356
city: Bursa
country: Turkey
facility: Local Institution - 360
city: Elazig
country: Turkey
facility: Local Institution - 365
city: Istanbul
country: Turkey
facility: Local Institution - 362
city: Istanbul
country: Turkey
facility: Local Institution - 358
city: Istanbul
country: Turkey
facility: Local Institution - 361
city: Istanbul
country: Turkey
facility: Local Institution - 355
city: Izmit/Kocaeli
country: Turkey
facility: Local Institution - 354
city: Kadiköy/Istanbul
country: Turkey
facility: Local Institution - 353
city: Trabzon
country: Turkey
facility: Local Institution - 359
city: Chernivtsi
country: Ukraine
facility: Local Institution - 914
city: Chernivtsi
country: Ukraine
facility: Local Institution - 922
city: Dnipropetrovsk
country: Ukraine
facility: Local Institution - 950
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution - 229
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution - 929
city: Ivano-Frankivsk
country: Ukraine
facility: Local Institution - 912
city: Kharkiv
country: Ukraine
facility: Local Institution - 919
city: Kharkiv
country: Ukraine
facility: Local Institution - 965
city: Khmelnytskyi
country: Ukraine
facility: Local Institution - 920
city: Kropyvnytskyi
country: Ukraine
facility: Local Institution - 933
city: Kyiv
country: Ukraine
facility: Local Institution - 901
city: Kyiv
country: Ukraine
facility: Local Institution - 923
city: Kyiv
country: Ukraine
facility: Local Institution - 915
city: Kyiv
country: Ukraine
facility: Local Institution - 243
city: Kyiv
country: Ukraine
facility: Local Institution - 563
city: Kyiv
country: Ukraine
facility: Local Institution - 911
city: Kyiv
country: Ukraine
facility: Local Institution - 244
city: Kyiv
country: Ukraine
facility: Local Institution - 564
city: Kyiv
country: Ukraine
facility: Local Institution - 918
city: Kyiv
country: Ukraine
facility: Local Institution - 908
city: Kyiv
country: Ukraine
facility: Local Institution - 977
city: Kyiv
country: Ukraine
facility: Local Institution - 562
city: Lutsk
country: Ukraine
facility: Local Institution - 240
city: Lutsk
country: Ukraine
facility: Local Institution - 590
city: Lviv
country: Ukraine
facility: Local Institution - 234
city: Lviv
country: Ukraine
facility: Local Institution - 974
city: Lviv
country: Ukraine
facility: Local Institution - 910
city: Odesa
country: Ukraine
facility: Local Institution - 242
city: Odesa
country: Ukraine
facility: Local Institution - 902
city: Poltava
country: Ukraine
facility: Local Institution - 905
city: Ternopil
country: Ukraine
facility: Local Institution - 934
city: Vinnytsia
country: Ukraine
facility: Local Institution - 909
city: Vinnytsia
country: Ukraine
facility: Local Institution - 224
city: Vinnytsia
country: Ukraine
facility: Local Institution - 924
city: Vinnytsia
country: Ukraine
facility: Local Institution - 971
city: Vinnytsya
country: Ukraine
facility: Local Institution - 932
city: Zaporizhia
country: Ukraine
facility: Local Institution - 587
city: Zaporizhzhya
country: Ukraine
facility: Local Institution - 925
city: Southampton
country: United Kingdom
facility: Local Institution - 723
state: Hampshire
city: London
country: United Kingdom
facility: Local Institution - 729
state: LND
city: Birmingham
country: United Kingdom
facility: Local Institution - 557
city: Bristol
country: United Kingdom
facility: Local Institution - 714
city: Cardiff
country: United Kingdom
facility: Local Institution - 560
city: Chorley
country: United Kingdom
facility: Local Institution - 558
city: Corbridge Road
country: United Kingdom
facility: Local Institution - 559
city: Dundonald
country: United Kingdom
facility: Local Institution - 712
city: Glasgow
country: United Kingdom
facility: Local Institution - 713
city: Lancashire Blackpool
country: United Kingdom
facility: Local Institution - 716
city: London
country: United Kingdom
facility: Local Institution - 722
city: London
country: United Kingdom
facility: Local Institution - 715
city: North Manchester Science Park
country: United Kingdom
facility: Local Institution - 561
city: Shrewsbury
country: United Kingdom
facility: Local Institution - 593
city: Torquay
country: United Kingdom
facility: Local Institution - 718
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.