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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
22/04/2025

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
Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64
Timepoint [1] 0 0
Week 64
Primary outcome [2] 0 0
Percentage 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 at Week 64
Timepoint [2] 0 0
Week 64
Secondary outcome [1] 0 0
Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of = 50% (ER-50) at Week 64
Timepoint [2] 0 0
Week 64
Secondary outcome [3] 0 0
Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of = 50% (ER-50) at Week 12 Based on Data as Observed
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score = 12.5 and a Total PCDAI Score of < 30 Points at Week 64
Timepoint [4] 0 0
Week 64
Secondary outcome [5] 0 0
Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score = 12.5 and a Total PCDAI Score of < 30 Points at Week 12 Based on Data as Observed
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Adolescents Who Achieve an Average Daily Abdominal Pain Score = 1 Point and an Average Daily Stool Frequency = 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12 Based on Data as Observed
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Adolescents Who Achieve an Average Daily Abdominal Pain Score = 1 Point and an Average Daily Stool Frequency = 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 64
Timepoint [7] 0 0
Week 64
Secondary outcome [8] 0 0
Change From Baseline in Stool Frequency (SF) Score at Week 64
Timepoint [8] 0 0
Baseline and Week 64
Secondary outcome [9] 0 0
Change From Baseline in Abdominal Pain (AP) Score at Week 64
Timepoint [9] 0 0
Baseline and Week 64
Secondary outcome [10] 0 0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 Based on Data as Observed
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 64
Timepoint [11] 0 0
Week 64
Secondary outcome [12] 0 0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Reduction From Baseline of = 100 Points or CDAI Score < 150 at Week 64
Timepoint [12] 0 0
Week 64
Secondary outcome [13] 0 0
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Reduction From Baseline of = 100 Points or CDAI Score < 150 at Week 12 Based on Data as Observed
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Percentage of Participants Who Achieve a Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks
Timepoint [14] 0 0
Week 64
Secondary outcome [15] 0 0
Percentage of Adolescents Who Achieve a Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks
Timepoint [15] 0 0
Week 64
Secondary outcome [16] 0 0
Percentage of Participants Who Achieve a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 64 While Remaining Corticosteroid Free in the Prior 12 Weeks
Timepoint [16] 0 0
Week 64
Secondary outcome [17] 0 0
Percentage 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 at Week 12 Based on Data as Observed
Timepoint [17] 0 0
Week 12
Secondary outcome [18] 0 0
Steady State Systemic Exposures of Ozanimod at Week 20 and Throughout the Study
Timepoint [18] 0 0
Week 20 and up to end of study (Week 64)
Secondary outcome [19] 0 0
Absolute Lymphocyte Count at Week 12 Based on Data as Observed
Timepoint [19] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [20] 0 0
Absolute Lymphocyte Count at Week 64
Timepoint [20] 0 0
Week 64
Secondary outcome [21] 0 0
Number of Participants With Adverse Events
Timepoint [21] 0 0
From first dose (Day 1) and up to Week 12

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
Stopped early
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
Actual
13/09/2024
Sample size
Target
Accrual to date
Final
5
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
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 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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT05470985