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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/NCT03467958




Registration number
NCT03467958
Ethics application status
Date submitted
12/03/2018
Date registered
16/03/2018
Date last updated
31/05/2024

Titles & IDs
Public title
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Scientific title
A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
U1111-1203-8203
Secondary ID [2] 0 0
RPC01-3204
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

Experimental: Administration of oral Ozanimod -


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

Outcomes
Primary outcome [1] 0 0
Proportion of participants with a CDAI score of < 150
Timepoint [1] 0 0
Up to 264 Weeks
Secondary outcome [1] 0 0
Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of = 50%
Timepoint [1] 0 0
Up to 264 Weeks
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
Up to 264 Weeks
Secondary outcome [3] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score of < 150
Timepoint [3] 0 0
Up to 264 Weeks
Secondary outcome [4] 0 0
Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%
Timepoint [4] 0 0
Up to 264 Weeks
Secondary outcome [5] 0 0
Proportion of participants with CDAI reduction from baseline of = 70 points
Timepoint [5] 0 0
Up to 264 Weeks
Secondary outcome [6] 0 0
Change from baseline in CDAI
Timepoint [6] 0 0
Up to 264 Weeks
Secondary outcome [7] 0 0
Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score of < 150 and SES-CD decrease from baseline of = 50%
Timepoint [7] 0 0
Up to 264 Weeks
Secondary outcome [8] 0 0
Proportion of participants with CDAI score of < 150 and SES-CD = 4 points and a SES-CD decrease = 2 points
Timepoint [8] 0 0
Up to 264 Weeks
Secondary outcome [9] 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 and SES-CD = 4 points and a SES-CD decrease = 2 points
Timepoint [9] 0 0
Up to 264 Weeks
Secondary outcome [10] 0 0
Proportion of participants with SES-CD = 4 points and a SES-CD decrease = 2 points
Timepoint [10] 0 0
Up to 264 Weeks
Secondary outcome [11] 0 0
Proportion of participants with a CDAI score < 150 in participants off corticosteroids
Timepoint [11] 0 0
Up to 264 Weeks
Secondary outcome [12] 0 0
Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%
Timepoint [12] 0 0
Up to 264 Weeks

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



- Is not in clinical response or clinical remission after completing 12 weeks in the
Induction Studies

- Experience relapse or who complete the Maintenance Study

- Complete a study of ozanimod for Crohn's Disease and meet the criteria for
participation
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological,
endocrine, psychiatric, or other major systemic disease making implementation of the
protocol or interpretation of the study difficult or that would put the subject at
risk by participating in the study

- Has suspected or diagnosed intra-abdominal or perianal abscess that has not been
appropriately treated

- Is receiving treatment with any of the following drugs or interventions: CYP2C8
inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/03/2031
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
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NSW,QLD,SA,VIC,WA
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Local Institution - 310 - Concord
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Local Institution - 318 - New Lambton Heights
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2139 - Concord
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2747 - Kingswood
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2170 - Liverpool
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2305 - New Lambton Heights
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3220 - Geelong
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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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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an extension study to evaluate safety and efficacy of ozanimod in participants with
moderately to severely active Crohn's Disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03467958
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
Recruiting sites have contact information. Please contact the site 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/ct2/show/NCT03467958