Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03440385
Registration number
NCT03440385
Ethics application status
Date submitted
14/02/2018
Date registered
22/02/2018
Date last updated
12/12/2023
Titles & IDs
Public title
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
U1111-1203-7949
Query!
Secondary ID [2]
0
0
RPC01-3202
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Crohn's disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Other interventions - Placebo
Experimental: Administration of oral Ozanimod -
Placebo comparator: Administration of Placebo -
Treatment: Drugs: Ozanimod
Specified dose on specified days
Other interventions: Placebo
Specified dose on specified days
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [1]
0
0
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
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [2]
0
0
Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50%
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Week 12
Query!
Secondary outcome [3]
0
0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Week 12
Query!
Secondary outcome [4]
0
0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 with SES-CD decrease from baseline of = 50%
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Week 12
Query!
Secondary outcome [5]
0
0
Proportion of participants with CDAI score < 150 with SES-CD decrease from baseline of = 50%
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Week 12
Query!
Secondary outcome [6]
0
0
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
Query!
Assessment method [6]
0
0
Both no worse than baseline and an SES-CD = 4 points and decrease =2 points
Query!
Timepoint [6]
0
0
Week 12
Query!
Secondary outcome [7]
0
0
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%
Query!
Assessment method [7]
0
0
Both no worse than baseline and an SES-CD decrease from baseline of = 50%
Query!
Timepoint [7]
0
0
Week 12
Query!
Secondary outcome [8]
0
0
Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Week 12
Query!
Secondary outcome [9]
0
0
Proportion of participants with CDAI reduction from baseline of = 70 points
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Week 12
Query!
Secondary outcome [10]
0
0
Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Week 12
Query!
Secondary outcome [11]
0
0
Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Week 12
Query!
Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
* 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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/03/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/11/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
606
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - 309 - Liverpool
Query!
Recruitment hospital [2]
0
0
Local Institution - 318 - New Lambton Heights
Query!
Recruitment hospital [3]
0
0
Local Institution - 328 - Herston
Query!
Recruitment hospital [4]
0
0
Local Institution - 313 - Maroorchydore
Query!
Recruitment hospital [5]
0
0
Local Institution - 321 - North Mackay
Query!
Recruitment hospital [6]
0
0
Local Institution - 312 - South Brisbane
Query!
Recruitment hospital [7]
0
0
Local Institution - 307 - Bedford Park
Query!
Recruitment hospital [8]
0
0
Local Institution - 326 - Elizabeth Vale
Query!
Recruitment hospital [9]
0
0
Local Institution - 317 - Clayton
Query!
Recruitment hospital [10]
0
0
Local Institution - 305 - Fitzroy
Query!
Recruitment hospital [11]
0
0
Local Institution - 329 - Geelong
Query!
Recruitment hospital [12]
0
0
Local Institution - 327 - Melbourne
Query!
Recruitment hospital [13]
0
0
Local Institution - 315 - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
2305 - New Lambton Heights
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4558 - Maroorchydore
Query!
Recruitment postcode(s) [5]
0
0
4740 - North Mackay
Query!
Recruitment postcode(s) [6]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [7]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [8]
0
0
05112 - Elizabeth Vale
Query!
Recruitment postcode(s) [9]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [10]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [11]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [12]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [13]
0
0
6008 - Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Hampshire
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oklahoma
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Utah
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Virginia
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Wisconsin
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Innsbruck
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
St Polten
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Vienna
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Ruse
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Sofia
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Alberta
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
British Columbia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Manitoba
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Ontario
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Quebec
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Jiangsu
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Shanghai
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Beijing
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Bengbu
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Changchun
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Changsha
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Changzhou
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Chengdu
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Fuzhou
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Guangzhou Shi
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Guangzhou
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Hangzhou, Zhejiang
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Hefei
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Kunming
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Luzhou
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Nanchang
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Nanjing City
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Nanjing
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Taichung City
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Tianjin
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Wuhan Shi
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Wuhan
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Wuxi
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Xi'an
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Zhengzhou
Query!
Country [62]
0
0
Colombia
Query!
State/province [62]
0
0
Armenia
Query!
Country [63]
0
0
Colombia
Query!
State/province [63]
0
0
Barranquilla
Query!
Country [64]
0
0
Colombia
Query!
State/province [64]
0
0
Bogota
Query!
Country [65]
0
0
Colombia
Query!
State/province [65]
0
0
Cali
Query!
Country [66]
0
0
Colombia
Query!
State/province [66]
0
0
Medellin
Query!
Country [67]
0
0
Finland
Query!
State/province [67]
0
0
Helsinki
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Cedex
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Blois Cedex
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Béziers
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Caen
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Colombes
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Nantes
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Pierre-Benite
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Saint Priest en Jarez
Query!
Country [76]
0
0
Georgia
Query!
State/province [76]
0
0
Batumi
Query!
Country [77]
0
0
Georgia
Query!
State/province [77]
0
0
Kutaisi
Query!
Country [78]
0
0
Georgia
Query!
State/province [78]
0
0
Tbilisi
Query!
Country [79]
0
0
Georgia
Query!
State/province [79]
0
0
Telavi
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Berlin
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Brandenburg an der Havel
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Dachau
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Frankfurt am Main
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Halle
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Hamburg
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Hannover
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Keil
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Leipzig
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Mainz
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Muenster
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Neuruppin
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Nuertingen
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Stuttgart
Query!
Country [94]
0
0
Greece
Query!
State/province [94]
0
0
Athens, Attiki
Query!
Country [95]
0
0
Greece
Query!
State/province [95]
0
0
Athens
Query!
Country [96]
0
0
Greece
Query!
State/province [96]
0
0
Heraklion
Query!
Country [97]
0
0
Greece
Query!
State/province [97]
0
0
Thessaloniki
Query!
Country [98]
0
0
Hong Kong
Query!
State/province [98]
0
0
Hong Kong
Query!
Country [99]
0
0
Hong Kong
Query!
State/province [99]
0
0
Kowloon
Query!
Country [100]
0
0
Hong Kong
Query!
State/province [100]
0
0
Sha Tin
Query!
Country [101]
0
0
Hungary
Query!
State/province [101]
0
0
Bekescsaba
Query!
Country [102]
0
0
Hungary
Query!
State/province [102]
0
0
Budapest
Query!
Country [103]
0
0
Hungary
Query!
State/province [103]
0
0
Gyor
Query!
Country [104]
0
0
Hungary
Query!
State/province [104]
0
0
Gyula
Query!
Country [105]
0
0
Hungary
Query!
State/province [105]
0
0
Miskolc
Query!
Country [106]
0
0
Hungary
Query!
State/province [106]
0
0
Nagykanizsa
Query!
Country [107]
0
0
Hungary
Query!
State/province [107]
0
0
Szekesfehervar
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Szekszárd
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Szentes
Query!
Country [110]
0
0
Israel
Query!
State/province [110]
0
0
Afula
Query!
Country [111]
0
0
Israel
Query!
State/province [111]
0
0
Beer Jacob
Query!
Country [112]
0
0
Israel
Query!
State/province [112]
0
0
Haifa
Query!
Country [113]
0
0
Israel
Query!
State/province [113]
0
0
Jerusalem
Query!
Country [114]
0
0
Israel
Query!
State/province [114]
0
0
Kfar-Saba
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
Petah Tikva
Query!
Country [116]
0
0
Israel
Query!
State/province [116]
0
0
Tel-Aviv
Query!
Country [117]
0
0
Korea, Republic of
Query!
State/province [117]
0
0
Busan
Query!
Country [118]
0
0
Korea, Republic of
Query!
State/province [118]
0
0
Daegu
Query!
Country [119]
0
0
Korea, Republic of
Query!
State/province [119]
0
0
Seoul
Query!
Country [120]
0
0
Korea, Republic of
Query!
State/province [120]
0
0
Suwon
Query!
Country [121]
0
0
Lithuania
Query!
State/province [121]
0
0
Kaunas
Query!
Country [122]
0
0
Lithuania
Query!
State/province [122]
0
0
Klaipeda
Query!
Country [123]
0
0
Lithuania
Query!
State/province [123]
0
0
Vilnius
Query!
Country [124]
0
0
Netherlands
Query!
State/province [124]
0
0
Amsterdam
Query!
Country [125]
0
0
Netherlands
Query!
State/province [125]
0
0
Groningen
Query!
Country [126]
0
0
Netherlands
Query!
State/province [126]
0
0
Nijmegen
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Sittard-Geleen
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Tilburg
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Czestochowa
Query!
Country [130]
0
0
Poland
Query!
State/province [130]
0
0
Elblag
Query!
Country [131]
0
0
Poland
Query!
State/province [131]
0
0
Gdansk
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Gdynia
Query!
Country [133]
0
0
Poland
Query!
State/province [133]
0
0
Jelenia Gora
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Jozefow
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Katowice
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Ksawerow
Query!
Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Lodz
Query!
Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Nowy Targ
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Rzeszow
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Sopot
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Szczecin
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Warsaw
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Warszawa
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Wierzchoslawice
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Wroclaw
Query!
Country [146]
0
0
Portugal
Query!
State/province [146]
0
0
Coimbra
Query!
Country [147]
0
0
Portugal
Query!
State/province [147]
0
0
Guimaraes
Query!
Country [148]
0
0
Portugal
Query!
State/province [148]
0
0
Loures
Query!
Country [149]
0
0
Portugal
Query!
State/province [149]
0
0
Viana do Castelo
Query!
Country [150]
0
0
Russian Federation
Query!
State/province [150]
0
0
Barnaul
Query!
Country [151]
0
0
Russian Federation
Query!
State/province [151]
0
0
Bataisk
Query!
Country [152]
0
0
Russian Federation
Query!
State/province [152]
0
0
Chelyabinsk
Query!
Country [153]
0
0
Russian Federation
Query!
State/province [153]
0
0
Ekaterinburg
Query!
Country [154]
0
0
Russian Federation
Query!
State/province [154]
0
0
Kaliningrad
Query!
Country [155]
0
0
Russian Federation
Query!
State/province [155]
0
0
Kaluga
Query!
Country [156]
0
0
Russian Federation
Query!
State/province [156]
0
0
Kemerovo
Query!
Country [157]
0
0
Russian Federation
Query!
State/province [157]
0
0
Moscow
Query!
Country [158]
0
0
Russian Federation
Query!
State/province [158]
0
0
Nizhny Novgorod
Query!
Country [159]
0
0
Russian Federation
Query!
State/province [159]
0
0
Novosibirsk
Query!
Country [160]
0
0
Russian Federation
Query!
State/province [160]
0
0
Omsk
Query!
Country [161]
0
0
Russian Federation
Query!
State/province [161]
0
0
Orenburg
Query!
Country [162]
0
0
Russian Federation
Query!
State/province [162]
0
0
Penza
Query!
Country [163]
0
0
Russian Federation
Query!
State/province [163]
0
0
Saint Petersburg
Query!
Country [164]
0
0
Russian Federation
Query!
State/province [164]
0
0
Saint-Petersburg
Query!
Country [165]
0
0
Russian Federation
Query!
State/province [165]
0
0
Samara
Query!
Country [166]
0
0
Russian Federation
Query!
State/province [166]
0
0
Saratov
Query!
Country [167]
0
0
Russian Federation
Query!
State/province [167]
0
0
Sochi
Query!
Country [168]
0
0
Russian Federation
Query!
State/province [168]
0
0
St Petersburg
Query!
Country [169]
0
0
Russian Federation
Query!
State/province [169]
0
0
St. Petersburg
Query!
Country [170]
0
0
Russian Federation
Query!
State/province [170]
0
0
Tomsk
Query!
Country [171]
0
0
Russian Federation
Query!
State/province [171]
0
0
Ufa
Query!
Country [172]
0
0
Russian Federation
Query!
State/province [172]
0
0
Volgograd
Query!
Country [173]
0
0
Senegal
Query!
State/province [173]
0
0
Cape Town
Query!
Country [174]
0
0
Serbia
Query!
State/province [174]
0
0
Belgrade
Query!
Country [175]
0
0
Serbia
Query!
State/province [175]
0
0
Kragujevac
Query!
Country [176]
0
0
Serbia
Query!
State/province [176]
0
0
Novi Sad
Query!
Country [177]
0
0
Serbia
Query!
State/province [177]
0
0
Pancevo
Query!
Country [178]
0
0
Serbia
Query!
State/province [178]
0
0
Vrsac
Query!
Country [179]
0
0
Serbia
Query!
State/province [179]
0
0
Zrenjanin
Query!
Country [180]
0
0
Slovakia
Query!
State/province [180]
0
0
Bratislava
Query!
Country [181]
0
0
Slovakia
Query!
State/province [181]
0
0
Brezno
Query!
Country [182]
0
0
Slovakia
Query!
State/province [182]
0
0
Nitra
Query!
Country [183]
0
0
Slovakia
Query!
State/province [183]
0
0
Nove Zamky
Query!
Country [184]
0
0
Slovakia
Query!
State/province [184]
0
0
Presov
Query!
Country [185]
0
0
Slovakia
Query!
State/province [185]
0
0
Rimavska Sobota
Query!
Country [186]
0
0
Slovenia
Query!
State/province [186]
0
0
Celje
Query!
Country [187]
0
0
South Africa
Query!
State/province [187]
0
0
Gauteng
Query!
Country [188]
0
0
South Africa
Query!
State/province [188]
0
0
Kempton Park
Query!
Country [189]
0
0
South Africa
Query!
State/province [189]
0
0
Pretoria
Query!
Country [190]
0
0
South Africa
Query!
State/province [190]
0
0
Somerset West
Query!
Country [191]
0
0
South Africa
Query!
State/province [191]
0
0
Val De Grace
Query!
Country [192]
0
0
Spain
Query!
State/province [192]
0
0
Barcelona
Query!
Country [193]
0
0
Spain
Query!
State/province [193]
0
0
Cordoba
Query!
Country [194]
0
0
Spain
Query!
State/province [194]
0
0
Girona
Query!
Country [195]
0
0
Spain
Query!
State/province [195]
0
0
Las Palmas de Gran Canaria
Query!
Country [196]
0
0
Spain
Query!
State/province [196]
0
0
Madrid
Query!
Country [197]
0
0
Spain
Query!
State/province [197]
0
0
Majadahonda, Madrid
Query!
Country [198]
0
0
Spain
Query!
State/province [198]
0
0
Santander
Query!
Country [199]
0
0
Spain
Query!
State/province [199]
0
0
Valencia
Query!
Country [200]
0
0
Sweden
Query!
State/province [200]
0
0
Stockholm
Query!
Country [201]
0
0
Taiwan
Query!
State/province [201]
0
0
Kaohsiung, San Ming Dist.
Query!
Country [202]
0
0
Taiwan
Query!
State/province [202]
0
0
Kaohsiung
Query!
Country [203]
0
0
Taiwan
Query!
State/province [203]
0
0
Niao-Sung Hsiang Kaohsiung County
Query!
Country [204]
0
0
Taiwan
Query!
State/province [204]
0
0
Tainan, Taiana
Query!
Country [205]
0
0
Taiwan
Query!
State/province [205]
0
0
Taoyuan City
Query!
Country [206]
0
0
Taiwan
Query!
State/province [206]
0
0
Tapei, Beitou Dist.
Query!
Country [207]
0
0
Taiwan
Query!
State/province [207]
0
0
Tapei
Query!
Country [208]
0
0
Turkey
Query!
State/province [208]
0
0
Ankara
Query!
Country [209]
0
0
Turkey
Query!
State/province [209]
0
0
Elazig
Query!
Country [210]
0
0
Turkey
Query!
State/province [210]
0
0
Istanbul
Query!
Country [211]
0
0
Turkey
Query!
State/province [211]
0
0
Kadiköy/Istanbul
Query!
Country [212]
0
0
Ukraine
Query!
State/province [212]
0
0
Chernivtsi
Query!
Country [213]
0
0
Ukraine
Query!
State/province [213]
0
0
Ivano-Frankivsk
Query!
Country [214]
0
0
Ukraine
Query!
State/province [214]
0
0
Kharkiv
Query!
Country [215]
0
0
Ukraine
Query!
State/province [215]
0
0
Khmelnytskyi
Query!
Country [216]
0
0
Ukraine
Query!
State/province [216]
0
0
Kropyvnytskyi
Query!
Country [217]
0
0
Ukraine
Query!
State/province [217]
0
0
Kyiv
Query!
Country [218]
0
0
Ukraine
Query!
State/province [218]
0
0
Lutsk
Query!
Country [219]
0
0
Ukraine
Query!
State/province [219]
0
0
Lviv
Query!
Country [220]
0
0
Ukraine
Query!
State/province [220]
0
0
Odesa
Query!
Country [221]
0
0
Ukraine
Query!
State/province [221]
0
0
Vinnytsia
Query!
Country [222]
0
0
Ukraine
Query!
State/province [222]
0
0
Vinnytsya
Query!
Country [223]
0
0
Ukraine
Query!
State/province [223]
0
0
Zaporizhia
Query!
Country [224]
0
0
Ukraine
Query!
State/province [224]
0
0
Zaporizhzhya
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Celgene
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03440385
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03440385
Download to PDF