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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05470985




Registration number
NCT05470985
Ethics application status
Date submitted
12/07/2022
Date registered
22/07/2022
Date last updated
26/07/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
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 Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
Secondary ID [1] 0 0
2021-005019-30
Secondary ID [2] 0 0
IM047-023
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: Ozanimod Dose Level 1 -

Experimental: Ozanimod Dose Level 2 -


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

Outcomes
Primary outcome [1] 0 0
Proportion of participants who achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10
Timepoint [1] 0 0
At week 64
Primary outcome [2] 0 0
Proportion of participants achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) = 2 or SES-CD = 4 points with no SES-CD subscore > 1 point
Timepoint [2] 0 0
At week 64
Secondary outcome [1] 0 0
Proportion of participants who achieve PCDAI < 10
Timepoint [1] 0 0
At week 12
Secondary outcome [2] 0 0
Proportion of participants who achieve SES-CD decrease from Baseline of = 50% (ER-50)
Timepoint [2] 0 0
At week 12 and week 64
Secondary outcome [3] 0 0
Proportion of participants who achieve reduction in PCDAI score = 12.5
Timepoint [3] 0 0
At week 12 and week 64
Secondary outcome [4] 0 0
Proportion of participants who achieve total PCDAI score of < 30 points
Timepoint [4] 0 0
At week 12 and week 64
Secondary outcome [5] 0 0
Proportion of adolescents who achieve an average daily abdominal pain score = 1 point
Timepoint [5] 0 0
At week 12 and week 64
Secondary outcome [6] 0 0
Proportion of adolescents who achieve an average daily stool frequency = 3 points with abdominal pain
Timepoint [6] 0 0
At week 12 and week 64
Secondary outcome [7] 0 0
Proportion of adolescents who achieve stool frequency no worse than Baseline
Timepoint [7] 0 0
At week 12 and week 64
Secondary outcome [8] 0 0
Change from Baseline in stool frequency score over time
Timepoint [8] 0 0
Up to 81 weeks
Secondary outcome [9] 0 0
Change from baseline in abdominal pain over time measured by Pediatric Crohn's Disease Activity Index (graded from 0-10)
Timepoint [9] 0 0
Up to 81 weeks
Secondary outcome [10] 0 0
Proportion of adolescents who achieve Crohn's Disease Activity Index (CDAI) score < 150
Timepoint [10] 0 0
At week 12 and week 64
Secondary outcome [11] 0 0
Proportion of adolescents who achieve CDAI reduction from Baseline of = 100 points or CDAI score < 150
Timepoint [11] 0 0
At week 12 and week 64
Secondary outcome [12] 0 0
Proportion of participants who achieve a PCDAI score < 10 while remaining corticosteroid free in the prior 12 weeks
Timepoint [12] 0 0
At week 64
Secondary outcome [13] 0 0
Proportion of participants who achieve a CDAI score < 150 while remaining corticosteroid free in the prior 12 weeks (adolescents only)
Timepoint [13] 0 0
At week 64
Secondary outcome [14] 0 0
Proportion of participants achieving SES-CD = 2 or SES-CD = 4 points with no SES-CD subscore > 1 point
Timepoint [14] 0 0
At week 12
Secondary outcome [15] 0 0
Steady state systemic exposures of ozanimod
Timepoint [15] 0 0
At week 20 and up to 81 weeks
Secondary outcome [16] 0 0
Steady state systemic exposures of CC112273
Timepoint [16] 0 0
At week 20 and up to 81 weeks
Secondary outcome [17] 0 0
Absolute change from Baseline in absolute lymphocyte count (ALC)
Timepoint [17] 0 0
At week 12, week 64, and up to 81 weeks
Secondary outcome [18] 0 0
Percent change from Baseline in ALC
Timepoint [18] 0 0
At week 12, week 64, and up to 81 weeks
Secondary outcome [19] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [19] 0 0
Up to 81 weeks
Secondary outcome [20] 0 0
Number of participants with Serious Adverse Events (SAEs)
Timepoint [20] 0 0
Up to 81 weeks

Eligibility
Key inclusion criteria
* Participants must have a Pediatric Crohn's Disease Activity Index (PCDAI) score = 30 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score = 6 (or SES-CD = 4 in participants with isolated ileal disease)
* Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD):

i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for CD
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study
* Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy
* Participant has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/03/2032
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Local Institution - 0045 - Joonladup
Recruitment postcode(s) [1] 0 0
6027 - Joonladup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Belgium
State/province [14] 0 0
BRU
Country [15] 0 0
Belgium
State/province [15] 0 0
VBR
Country [16] 0 0
Belgium
State/province [16] 0 0
WLG
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussel
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
France
State/province [22] 0 0
Bron
Country [23] 0 0
France
State/province [23] 0 0
Caen
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Toulouse
Country [26] 0 0
Germany
State/province [26] 0 0
SN
Country [27] 0 0
Hungary
State/province [27] 0 0
Miskolc
Country [28] 0 0
Hungary
State/province [28] 0 0
Szeged
Country [29] 0 0
Poland
State/province [29] 0 0
MZ
Country [30] 0 0
Poland
State/province [30] 0 0
PK
Country [31] 0 0
Poland
State/province [31] 0 0
Lodz
Country [32] 0 0
Poland
State/province [32] 0 0
Warsaw
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Spain
State/province [34] 0 0
B
Country [35] 0 0
Spain
State/province [35] 0 0
Badalona
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelone
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
Trial website
https://clinicaltrials.gov/study/NCT05470985
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 http://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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05470985