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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05076175




Registration number
NCT05076175
Ethics application status
Date submitted
4/10/2021
Date registered
13/10/2021

Titles & IDs
Public title
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Scientific title
A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
Secondary ID [1] 0 0
2021-002308-11
Secondary ID [2] 0 0
IM047-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

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

Experimental: Ozanimod High Dose -

Experimental: Ozanimod Low Dose -


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 who achieve clinical remission
Timepoint [1] 0 0
At Week 52
Secondary outcome [1] 0 0
Proportion of participants who achieve clinical remission
Timepoint [1] 0 0
At Week 10
Secondary outcome [2] 0 0
Proportion of participants who achieve clinical response
Timepoint [2] 0 0
At Week 52
Secondary outcome [3] 0 0
Proportion of participants who achieve clinical response
Timepoint [3] 0 0
At Week 10
Secondary outcome [4] 0 0
Proportion of participants who achieve symptomatic remission
Timepoint [4] 0 0
At Week 10 and Week 52
Secondary outcome [5] 0 0
Time to achievement of symptomatic remission
Timepoint [5] 0 0
Up to 6 years
Secondary outcome [6] 0 0
Proportion of participants who achieve endoscopic improvement
Timepoint [6] 0 0
At Week 10 and Week 52
Secondary outcome [7] 0 0
Proportion of participants who achieve corticosteroid free remission
Timepoint [7] 0 0
At Week 52
Secondary outcome [8] 0 0
Incidence of Adverse Events (AEs)
Timepoint [8] 0 0
Up to 6 years
Secondary outcome [9] 0 0
Incidence of Serious Adverse Events
Timepoint [9] 0 0
Up to 6 years
Secondary outcome [10] 0 0
Incidence of AEs leading to discontinuation from treatment
Timepoint [10] 0 0
Up to 6 years
Secondary outcome [11] 0 0
Incidence of AEs of special interest (AESIs)
Timepoint [11] 0 0
Up to 6 years
Secondary outcome [12] 0 0
Steady state systemic exposure of ozanimod and CC112273
Timepoint [12] 0 0
At Week 18 and throughout the study, up to 70 weeks
Secondary outcome [13] 0 0
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Timepoint [13] 0 0
Up to 6 years
Secondary outcome [14] 0 0
Percent change from baseline in ALC
Timepoint [14] 0 0
Up to 6 years

Eligibility
Key inclusion criteria
* Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
* Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
* Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of Crohn's disease or indeterminate colitis
* Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
* Apheresis within 2 weeks of randomization
* History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis

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 2
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
30/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/08/2031
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0094 - Westmead
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Local Institution - 0086 - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
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United States of America
State/province [11] 0 0
Minnesota
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United States of America
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Missouri
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United States of America
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New York
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North Carolina
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Ohio
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United States of America
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Oklahoma
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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United States of America
State/province [20] 0 0
Wisconsin
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Belgium
State/province [21] 0 0
Bruxelles-Capitale, Région De
Country [22] 0 0
Belgium
State/province [22] 0 0
Vlaams-Brabant
Country [23] 0 0
Belgium
State/province [23] 0 0
Brussels
Country [24] 0 0
Belgium
State/province [24] 0 0
Edegem
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
France
State/province [27] 0 0
Haute-Garonne
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France
State/province [28] 0 0
Bron
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France
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Caen
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France
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Paris
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Germany
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Bayern
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Germany
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Dresden
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Israel
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HaMerkaz
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Israel
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HaTsafon
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Israel
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Yerushalayim
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Hiroshima
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Poland
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Dolnoslaskie
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Poland
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Mazowieckie
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Poland
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Malopolskie
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Podkarpackie
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Pomorskie
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Zachodniopomorskie
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Lódzkie
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Russian Federation
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Moscow
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Russian Federation
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Moskva
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Spain
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Barcelona [Barcelona]
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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United Kingdom
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England
Country [56] 0 0
United Kingdom
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Greater London
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


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/NCT05076175