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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03464097




Registration number
NCT03464097
Ethics application status
Date submitted
26/02/2018
Date registered
13/03/2018
Date last updated
4/11/2024

Titles & IDs
Public title
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
U1111-1203-8002
Secondary ID [2] 0 0
RPC01-3203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Other interventions - Placebo

Experimental: Ozanimod -

Placebo comparator: Placebo -


Treatment: Drugs: Ozanimod
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Crohn's Disease Activity Index (CDAI) score < 150
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Proportion of participants with Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline = 50%
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of participants with CDAI reduction from baseline = 100 points or CDAI score < 150
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Proportion of participants with CDAI score < 150 in participants with CDAI score < 150 at Maintenance Day 1
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline = 50%
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Proportion of participants with CDAI reduction from baseline = 100 points or CDAI score < 150 and SES-CD decrease from baseline = 50%
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Proportion of participants with CDAI score < 150 at Maintenance Day 1 and SES-CD decrease from baseline =50%
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Proportion of participants with CDAI reduction from baseline = 70 points
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline = 50%
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 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 and SES-CD decrease from baseline = 50%
Timepoint [16] 0 0
Week 52

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



* 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/10/2024
Sample size
Target
Accrual to date
Final
551
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 310 - Concord
Recruitment hospital [2] 0 0
Local Institution - 319 - Kingswood
Recruitment hospital [3] 0 0
Local Institution - 309 - Liverpool
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Local Institution - 318 - New Lambton Heights
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Local Institution - 323 - Wollongong
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Local Institution - 328 - Herston
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Local Institution - 707 - Maroochydore
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Local Institution - 321 - North Mackay
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Local Institution - 312 - South Brisbane
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Local Institution - 308 - Adelaide
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Local Institution - 708 - Adelaide
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Local Institution - 307 - Bedford Park
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Local Institution - 326 - Elizabeth Vale
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Local Institution - 320 - Woodville South
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Local Institution - 317 - Clayton
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Local Institution - 305 - Fitzroy
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Local Institution - 329 - Geelong
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Local Institution - 327 - Melbourne
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Local Institution - 709 - Melbourne
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Local Institution - 316 - Murdoch
Recruitment hospital [23] 0 0
Local Institution - 315 - Subiaco
Recruitment hospital [24] 0 0
Local Institution - 325 - Bankstown
Recruitment hospital [25] 0 0
Local Institution - 330 - Box Hill
Recruitment hospital [26] 0 0
Local Institution - 324 - Sydney, NSW
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
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2305 - New Lambton Heights
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2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4029 - Herston
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4558 - Maroochydore
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4558 - Maroorchydore
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4740 - North Mackay
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4101 - South Brisbane
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4102 - Woolloongabba
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
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5112 - Adelaide
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5042 - Bedford Park
Recruitment postcode(s) [15] 0 0
05112 - Elizabeth Vale
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5011 - Woodville South
Recruitment postcode(s) [17] 0 0
3168 - Clayton
Recruitment postcode(s) [18] 0 0
3065 - Fitzroy
Recruitment postcode(s) [19] 0 0
3220 - Geelong
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3004 - Melbourne
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6150 - Murdoch
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6008 - Subiaco
Recruitment postcode(s) [23] 0 0
2200 - Bankstown
Recruitment postcode(s) [24] 0 0
3128 - Box Hill
Recruitment postcode(s) [25] 0 0
NSW 2050 - Sydney, NSW
Recruitment outside Australia
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03464097
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03464097