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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03440372
Registration number
NCT03440372
Ethics application status
Date submitted
14/02/2018
Date registered
22/02/2018
Date last updated
14/05/2024
Titles & IDs
Public title
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
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Scientific 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
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Secondary ID [1]
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U1111-1203-7225
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Secondary ID [2]
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RPC01-3201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
0
0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150
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Assessment method [1]
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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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
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Assessment method [1]
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0
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50%
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Assessment method [2]
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0
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150
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Assessment method [3]
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0
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 and SES-CD decrease from baseline of = 50%
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Assessment method [4]
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0
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of = 50%
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Assessment method [5]
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0
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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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
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Assessment method [6]
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0
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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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%
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Assessment method [7]
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0
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes)
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Assessment method [8]
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Timepoint [8]
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Week 12
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Secondary outcome [9]
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Proportion of participants with CDAI reduction from baseline of = 70 points
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Assessment method [9]
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%
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Assessment method [10]
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Timepoint [10]
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Week 12
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Secondary outcome [11]
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Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%
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Assessment method [11]
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Timepoint [11]
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Week 12
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/03/2025
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 310 - Concord
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Local Institution - 319 - Kingswood
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Local Institution - 330 - Box Hill
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Local Institution - 324 - Sydney, NSW
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2139 - Concord
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2747 - Kingswood
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2500 - Wollongong
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4558 - Maroochydore
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4102 - Woolloongabba
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5000 - Adelaide
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5112 - Adelaide
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5011 - Woodville South
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3004 - Melbourne
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6150 - Murdoch
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2200 - Bankstown
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3128 - Box Hill
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NSW 2050 - Sydney, NSW
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Recruitment outside Australia
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Italy
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Mexico
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Mexico
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Tychy
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Ul. Piotrkowska 177
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Romania
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Russian Federation
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Chita
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Russian Federation
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Russian Federation
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Pushkin
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Russian Federation
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St. Petersburg
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Riyadh
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Bern
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Kozlu
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Turkey
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Kyiv
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United Kingdom
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Hampshire
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Dundonald
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London
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North Manchester Science Park
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United Kingdom
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Shrewsbury
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United Kingdom
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Torquay
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celgene
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Address
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Country
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03440372
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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.
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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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/NCT03440372
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