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
NCT ID: NCT05470985
Last Updated: 2025-04-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2/PHASE3
5 participants
INTERVENTIONAL
2023-08-22
2024-09-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
NCT03464097
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
NCT05076175
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
NCT03440372
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
NCT03467958
Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease
NCT05057273
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ozanimod Dose Level 1
Ozanimod
Specific dose on specific days
Ozanimod Dose Level 2
Ozanimod
Specific dose on specific days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ozanimod
Specific dose on specific days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
2 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0010
Garden Grove, California, United States
Local Institution - 0028
Los Angeles, California, United States
Local Institution - 0002
Sacramento, California, United States
Local Institution - 0009
San Francisco, California, United States
Local Institution - 0011
Hartford, Connecticut, United States
Local Institution - 0044
Orlando, Florida, United States
Local Institution - 0037
Orlando, Florida, United States
Local Institution - 0053
Atlanta, Georgia, United States
Local Institution - 0059
Indianapolis, Indiana, United States
Local Institution - 0038
Springfield, Massachusetts, United States
Local Institution - 0006
Detroit, Michigan, United States
Local Institution - 0003
Rochester, Minnesota, United States
Local Institution - 0016
St Louis, Missouri, United States
Local Institution - 0071
Lebanon, New Hampshire, United States
Local Institution - 0060
New York, New York, United States
Local Institution - 0075
Fort Worth, Texas, United States
Local Institution - 0070
Houston, Texas, United States
Local Institution - 0008
Seattle, Washington, United States
Local Institution - 0040
Tacoma, Washington, United States
Local Institution - 0045
Joonladup, Western Australia, Australia
Local Institution - 0058
Brussels, BRU, Belgium
Local Institution - 0023
Leuven, VBR, Belgium
Local Institution - 0048
Liège, WLG, Belgium
Local Institution - 0062
Liège, WLG, Belgium
Local Institution - 0047
Brussels, , Belgium
Local Institution - 0055
Brussels, , Belgium
Local Institution - 0014
Halifax, Nova Scotia, Canada
Local Institution - 0001
London, Ontario, Canada
Local Institution - 0054
Montreal, Quebec, Canada
Local Institution - 0066
Bron, , France
Local Institution - 0065
Caen, , France
Local Institution - 0072
Paris, , France
Local Institution - 0063
Toulouse, , France
Local Institution - 0057
Dresden, Saxony, Germany
Local Institution - 0067
Leipzig, Saxony, Germany
Local Institution - 0015
Miskolc, , Hungary
Local Institution - 0026
Szeged, , Hungary
Local Institution - 0007
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0052
Rzeszów, Podkarpackie Voivodeship, Poland
Local Institution - 0061
Lodz, , Poland
Local Institution - 0031
Warsaw, , Poland
Local Institution - 0033
Warsaw, , Poland
Local Institution - 0025
Barcelona, B, Spain
Local Institution - 0030
Badalona, , Spain
Local Institution - 0035
Barcelona, , Spain
Local Institution - 0017
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-005019-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM047-023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.