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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
U1111-1203-7225
Secondary ID [2] 0 0
RPC01-3201
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: 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
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 a Crohn's Disease Activity Index (CDAI) score < 150
Timepoint [1] 0 0
Week 12
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
Timepoint [1] 0 0
Week 12
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%
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 and SES-CD decrease from baseline of = 50%
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of = 50%
Timepoint [5] 0 0
Week 12
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
Timepoint [6] 0 0
Week 12
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%
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes)
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Proportion of participants with CDAI reduction from baseline of = 70 points
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%
Timepoint [11] 0 0
Week 12

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

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/03/2025
Actual
Sample size
Target
600
Accrual to date
Final
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 - 323 - Wollongong
Recruitment hospital [4] 0 0
Local Institution - 707 - Maroochydore
Recruitment hospital [5] 0 0
Local Institution - 311 - Woolloongabba
Recruitment hospital [6] 0 0
Local Institution - 308 - Adelaide
Recruitment hospital [7] 0 0
Local Institution - 708 - Adelaide
Recruitment hospital [8] 0 0
Local Institution - 320 - Woodville South
Recruitment hospital [9] 0 0
Local Institution - 709 - Melbourne
Recruitment hospital [10] 0 0
Local Institution - 316 - Murdoch
Recruitment hospital [11] 0 0
Local Institution - 325 - Bankstown
Recruitment hospital [12] 0 0
Local Institution - 330 - Box Hill
Recruitment hospital [13] 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
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
Recruitment postcode(s) [12] 0 0
3128 - Box Hill
Recruitment postcode(s) [13] 0 0
NSW 2050 - Sydney, NSW
Recruitment outside Australia
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Turkey
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Chernivtsi
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Dnipropetrovsk
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Kharkiv
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Kyiv
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Bristol
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Chorley
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Torquay

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 explore the effect of oral ozanimod as an induction treatment for
participants with moderately to severely active Crohn's Disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03440372
Trial related presentations / publications
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries