Back to resultsA 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
Primary Purpose
Crohn Disease
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ozanimod
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
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
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.
Sites / Locations
- Phoenix Children's Hospital
- Valley View Wellness Medical CenterRecruiting
- Children's Hospital Los Angeles
- Cedars-Sinai Medical Center (CSMC) - Maxine Dunitz Children's Health Center
- UC Davis Medical Center - UC Davis Medical Group - Pediatric Specialty ClinicsRecruiting
- UCSF Medical Center- Mission BayRecruiting
- Children's Hospital Colorado
- Connecticut Children's Medical CenterRecruiting
- AdventHealth (Florida Hospital) Medical Group - Pediatric Gastroenterology - OrlandoRecruiting
- Arnold Palmer Hospital for Children - Center for Digestive Health and Nutrition - Downtown OrlandoRecruiting
- Emory-Children's Center
- Riley Hospital For ChildrenRecruiting
- University of Iowa Stead Family Children's Hospital
- Johns Hopkins Children's Center - Pediatric Inflammatory Bowel Disease (IBD) Center
- Boston Children's Hospital
- Baystate Medical CenterRecruiting
- Children'S Hospital Of MichiganRecruiting
- Mayo Clinic - Children's Center - Rochester
- Washington University School of Medicine in St. Louis - St. Louis Children's HospitalRecruiting
- Dartmouth-Hitchcock Medical Center (DHMC) - Children's Hospital at Dartmouth (CHaD) - Lebanon
- Morristown Medical Center
- Valley Medical Group (VMG) - Pediatric Gastroenterology
- The Children's Hospital at Montefiore
- Icahn School of Medicine - The Mount Sinai Hospital - The Susan and Leonard Feinstein IBD Center
- Morgan Stanley Children's Hospital of NewYork-PresbyterianRecruiting
- University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
- University Hospitals Cleveland Medical Center
- Oklahoma Pediatric Digestive Institute (OPDI)
- Measurable Outcomes Research
- Cook Children's Gastroenterology
- Texas Children's Hospital
- Seattle Children's Hospital, Research and Foundation
- Mary Bridge Children's Outpatient Center - TacomaRecruiting
- Children's Hospital of Wisconsin - Neenah Clinic
- Local Institution - 0068
- Local Institution - 0029
- Local Institution - 0036
- Local Institution - 0051
- Local Institution - 0056
- Local Institution - 0045
- Local Institution - 0058
- Local Institution - 0023Recruiting
- Local Institution - 0062
- Local Institution - 0048
- Local Institution - 0047
- Local Institution - 0055Recruiting
- Local Institution - 0014
- Local Institution - 0001
- Local Institution - 0039
- Local Institution - 0054
- Local Institution - 0066
- Local Institution - 0065
- Local Institution - 0072
- Local Institution - 0063
- Local Institution - 0073
- Local Institution - 0077
- Local Institution - 0057
- Local Institution - 0067
- Local Institution - 0074
- Local Institution - 0019
- Local Institution - 0015Recruiting
- Local Institution - 0026Recruiting
- Local Institution - 0041
- Local Institution - 0007Recruiting
- Local Institution - 0052Recruiting
- Local Institution - 0061Recruiting
- Local Institution - 0033Recruiting
- Local Institution - 0031Recruiting
- Local Institution - 0025Recruiting
- Local Institution - 0030
- Local Institution - 0035Recruiting
- Local Institution - 0017Recruiting
- Local Institution - 0021
- Local Institution - 0013
- Local Institution - 0046
- Local Institution - 0050
- Local Institution - 0069
- Local Institution - 0049
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ozanimod Dose Level 1
Ozanimod Dose Level 2
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants who achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10
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
Secondary Outcome Measures
Proportion of participants who achieve PCDAI < 10
Proportion of participants who achieve SES-CD decrease from Baseline of ≥ 50% (ER-50)
Proportion of participants who achieve reduction in PCDAI score ≥ 12.5
Proportion of participants who achieve total PCDAI score of < 30 points
Proportion of adolescents who achieve an average daily abdominal pain score ≤ 1 point
Proportion of adolescents who achieve an average daily stool frequency ≤ 3 points with abdominal pain
Proportion of adolescents who achieve stool frequency no worse than Baseline
Change from Baseline in stool frequency score over time
Change from baseline in abdominal pain over time measured by Pediatric Crohn's Disease Activity Index (graded from 0-10)
Proportion of adolescents who achieve Crohn's Disease Activity Index (CDAI) score < 150
Proportion of adolescents who achieve CDAI reduction from Baseline of ≥ 100 points or CDAI score < 150
Proportion of participants who achieve a PCDAI score < 10 while remaining corticosteroid free in the prior 12 weeks
Proportion of participants who achieve a CDAI score < 150 while remaining corticosteroid free in the prior 12 weeks (adolescents only)
Proportion of participants achieving SES-CD ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point
Steady state systemic exposures of ozanimod
Steady state systemic exposures of CC112273
Absolute change from Baseline in absolute lymphocyte count (ALC)
Percent change from Baseline in ALC
Number of participants with Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05470985
Brief 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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
September 24, 2026 (Anticipated)
Study Completion Date
March 16, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ozanimod Dose Level 1
Arm Type
Experimental
Arm Title
Ozanimod Dose Level 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ozanimod
Other Intervention Name(s)
BMS-986374, RPC1063
Intervention Description
Specific dose on specific days
Primary Outcome Measure Information:
Title
Proportion of participants who achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10
Time Frame
At week 64
Title
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
Time Frame
At week 64
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve PCDAI < 10
Time Frame
At week 12
Title
Proportion of participants who achieve SES-CD decrease from Baseline of ≥ 50% (ER-50)
Time Frame
At week 12 and week 64
Title
Proportion of participants who achieve reduction in PCDAI score ≥ 12.5
Time Frame
At week 12 and week 64
Title
Proportion of participants who achieve total PCDAI score of < 30 points
Time Frame
At week 12 and week 64
Title
Proportion of adolescents who achieve an average daily abdominal pain score ≤ 1 point
Time Frame
At week 12 and week 64
Title
Proportion of adolescents who achieve an average daily stool frequency ≤ 3 points with abdominal pain
Time Frame
At week 12 and week 64
Title
Proportion of adolescents who achieve stool frequency no worse than Baseline
Time Frame
At week 12 and week 64
Title
Change from Baseline in stool frequency score over time
Time Frame
Up to 81 weeks
Title
Change from baseline in abdominal pain over time measured by Pediatric Crohn's Disease Activity Index (graded from 0-10)
Time Frame
Up to 81 weeks
Title
Proportion of adolescents who achieve Crohn's Disease Activity Index (CDAI) score < 150
Time Frame
At week 12 and week 64
Title
Proportion of adolescents who achieve CDAI reduction from Baseline of ≥ 100 points or CDAI score < 150
Time Frame
At week 12 and week 64
Title
Proportion of participants who achieve a PCDAI score < 10 while remaining corticosteroid free in the prior 12 weeks
Time Frame
At week 64
Title
Proportion of participants who achieve a CDAI score < 150 while remaining corticosteroid free in the prior 12 weeks (adolescents only)
Time Frame
At week 64
Title
Proportion of participants achieving SES-CD ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point
Time Frame
At week 12
Title
Steady state systemic exposures of ozanimod
Time Frame
At week 20 and up to 81 weeks
Title
Steady state systemic exposures of CC112273
Time Frame
At week 20 and up to 81 weeks
Title
Absolute change from Baseline in absolute lymphocyte count (ALC)
Time Frame
At week 12, week 64, and up to 81 weeks
Title
Percent change from Baseline in ALC
Time Frame
At week 12, week 64, and up to 81 weeks
Title
Number of participants with Adverse Events (AEs)
Time Frame
Up to 81 weeks
Title
Number of participants with Serious Adverse Events (SAEs)
Time Frame
Up to 81 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center http://www.bmsstudyconnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Individual Site Status
Withdrawn
Facility Name
Valley View Wellness Medical Center
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845-2032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kurtz, Site 0010
Phone
855-229-1665
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-6062
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cedars-Sinai Medical Center (CSMC) - Maxine Dunitz Children's Health Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shervin Rabizadeh, Site 0076
Phone
310-423-7100
Facility Name
UC Davis Medical Center - UC Davis Medical Group - Pediatric Specialty Clinics
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trinh Truong, Site 0002
Facility Name
UCSF Medical Center- Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Verstraete, Site 0009
Phone
415-502-3741
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-7106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106-3322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Hyams, Site 0011
Phone
860-545-2571
Facility Name
AdventHealth (Florida Hospital) Medical Group - Pediatric Gastroenterology - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1469
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regino Gonzalez-Peralta, Site 0044
Phone
352-514-7349
Facility Name
Arnold Palmer Hospital for Children - Center for Digestive Health and Nutrition - Downtown Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bornstein, Site 0037
Phone
919-684-2052
Facility Name
Emory-Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30302
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subramaniam Kugathasan, Site 0053
Facility Name
Riley Hospital For Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyi (Tina) Zhang, Site 0059
Facility Name
University of Iowa Stead Family Children's Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Individual Site Status
Withdrawn
Facility Name
Johns Hopkins Children's Center - Pediatric Inflammatory Bowel Disease (IBD) Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Withdrawn
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-5724
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athos Bousvaros, Site 0032
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wael Sayej, Site 0038
Phone
413-794-2305
Facility Name
Children'S Hospital Of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2196
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Cares, Site 0006
Phone
313-745-5585
Facility Name
Mayo Clinic - Children's Center - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Stephens, Site 0003
Phone
111111
Facility Name
Washington University School of Medicine in St. Louis - St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Samson, Site 0016
Phone
513-518-8949
Facility Name
Dartmouth-Hitchcock Medical Center (DHMC) - Children's Hospital at Dartmouth (CHaD) - Lebanon
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-1000
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amer Al-Nimr, Site 0071
Phone
603-653-9666
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Valley Medical Group (VMG) - Pediatric Gastroenterology
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Dankner, Site 0043
Phone
516-398-6397
Facility Name
The Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2403
Country
United States
Individual Site Status
Withdrawn
Facility Name
Icahn School of Medicine - The Mount Sinai Hospital - The Susan and Leonard Feinstein IBD Center
City
New York
State/Province
New York
ZIP/Postal Code
10029-5204
Country
United States
Individual Site Status
Withdrawn
Facility Name
Morgan Stanley Children's Hospital of NewYork-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032-1559
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSEPH PICORARO, Site 0060
Phone
207-653-9312
Facility Name
University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oklahoma Pediatric Digestive Institute (OPDI)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Shambayati, Site 0079
Phone
405-546-1340
Facility Name
Measurable Outcomes Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4470
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cook Children's Gastroenterology
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-2710
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clifton Huang, Site 0075
Phone
559-353-5746
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2316
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Karam, Site 0070
Phone
832-822-3612
Facility Name
Seattle Children's Hospital, Research and Foundation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-3901
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghassan Wahbeh, Site 0008
Phone
111111
Facility Name
Mary Bridge Children's Outpatient Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-3720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghu Varier, Site 0040
Phone
503-847-4748
Facility Name
Children's Hospital of Wisconsin - Neenah Clinic
City
Neenah
State/Province
Wisconsin
ZIP/Postal Code
54956-2883
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Aziz Elkadri, Site 0078
Facility Name
Local Institution - 0068
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0068
Facility Name
Local Institution - 0029
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0036
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0051
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0056
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0045
City
Joonladup
State/Province
Western Australia
ZIP/Postal Code
6027
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0045
Facility Name
Local Institution - 0058
City
Brussel
State/Province
BRU
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0023
City
Leuven
State/Province
VBR
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0062
City
Liege
State/Province
WLG
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0062
Facility Name
Local Institution - 0048
City
Liège
State/Province
WLG
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0047
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
Local Institution - 0055
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0055
Facility Name
Local Institution - 0014
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0001
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0039
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0054
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0066
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0066
Facility Name
Local Institution - 0065
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0065
Facility Name
Local Institution - 0072
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0072
Facility Name
Local Institution - 0063
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0063
Facility Name
Local Institution - 0073
City
Munchen
State/Province
BY
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0077
City
Wuppertal
State/Province
Northwest
ZIP/Postal Code
42283
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0077
Facility Name
Local Institution - 0057
City
Dresden
State/Province
SN
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0067
City
Leipzig
State/Province
SN
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0067
Facility Name
Local Institution - 0074
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0074
Facility Name
Local Institution - 0019
City
Miskolc
State/Province
BZ
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0015
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0026
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0041
City
Krakow
State/Province
MA
ZIP/Postal Code
30-694
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0041
Facility Name
Local Institution - 0007
City
Warszawa
State/Province
MZ
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0052
City
Rzeszow
State/Province
PK
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0061
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0061
Facility Name
Local Institution - 0033
City
Warsaw
ZIP/Postal Code
04-746
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0031
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0025
City
Barcelona
State/Province
B
ZIP/Postal Code
8950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 0030
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0035
City
Barcelone
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0017
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0021
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0013
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0046
City
Birmingham
State/Province
BIR
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0050
City
London
State/Province
LND
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0069
City
Sheffield
State/Province
SHF
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0049
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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
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