search
Back to results

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ozanimod
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Ulcerative Colitis, Ozanimod, Pediatric

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Local Institution - 0041
  • University of Arizona
  • Local Institution - 0052
  • Loma Linda University Health System
  • Cedars-Sinai Medical Center
  • Lucile Packard Children's Hospital
  • Local Institution - 0007
  • Children's National Medical Center
  • AdventHealth Orlando
  • Local Institution - 0016Recruiting
  • University of IowaRecruiting
  • Maine Medical Partners
  • Local Institution - 0005
  • Local Institution - 0042Recruiting
  • Mayo Clinic in Rochester, Minnesota
  • Washington University
  • Local Institution - 0028Recruiting
  • Local Institution - 0040
  • Local Institution - 0023
  • University of North Carolina Medical Center
  • Atrium Health - Carolinas Medical CenterRecruiting
  • Local Institution - 0036
  • Measurable Outcomes Research
  • Penn State Milton S. Hershey Medical CenterRecruiting
  • Texas Children's Hospital
  • Seattle Children's HospitalRecruiting
  • Swedish Medical Center
  • MultiCare Health System
  • Local Institution - 0037
  • Local Institution - 0085
  • Local Institution - 0086
  • Local Institution - 0076
  • Local Institution - 0059Recruiting
  • Local Institution - 0056
  • Local Institution - 0063
  • Local Institution - 0061
  • Local Institution - 0071
  • Local Institution - 0083
  • Local Institution - 0082
  • CHU de Toulouse - Hôpital des EnfantsRecruiting
  • Hospices Civils de Lyon - Hôpital Femme Mère EnfantRecruiting
  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de NacreRecruiting
  • Hôpital Universitaire Necker Enfants MaladesRecruiting
  • Local Institution - 0073
  • Klinikum der Ludwig-Maximilians-Universitaet MuenchenRecruiting
  • Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
  • Local Institution - 0020Recruiting
  • Local Institution - 0018Recruiting
  • Local Institution - 0019Recruiting
  • Local Institution - 0025Recruiting
  • Local Institution - 0011Recruiting
  • Local Institution - 0068Recruiting
  • Local Institution - 0038Recruiting
  • Local Institution - 0021Recruiting
  • Local Institution - 0024Recruiting
  • Local Institution - 0009Recruiting
  • Local Institution - 0033Recruiting
  • Local Institution - 0069Recruiting
  • Local Institution - 0010Recruiting
  • Local Institution - 0012
  • Local Institution - 0043
  • Local Institution - 0014Recruiting
  • Local Institution - 0084
  • Local Institution - 0015
  • Local Institution - 0013
  • Local Institution - 0079
  • Local Institution - 0088
  • Local Institution
  • Local Institution
  • Local Institution - 0048Recruiting
  • Local Institution - 0051Recruiting
  • Local Institution - 0044Recruiting
  • Local Institution - 0057
  • Local Institution - 0050
  • Local Institution - 0054
  • Local Institution - 0066
  • Local Institution - 0026

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ozanimod High Dose

Ozanimod Low Dose

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants who achieve clinical remission

Secondary Outcome Measures

Proportion of participants who achieve clinical remission
Proportion of participants who achieve clinical response
Proportion of participants who achieve clinical response
Proportion of participants who achieve symptomatic remission
Time to achievement of symptomatic remission
Proportion of participants who achieve endoscopic improvement
Proportion of participants who achieve corticosteroid free remission
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events
Incidence of AEs leading to discontinuation from treatment
Incidence of AEs of special interest (AESIs)
Steady state systemic exposure of ozanimod and CC112273
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Percent change from baseline in ALC

Full Information

First Posted
October 4, 2021
Last Updated
September 29, 2023
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT05076175
Brief Title
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
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 Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
May 22, 2026 (Anticipated)
Study Completion Date
August 14, 2031 (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 effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Ulcerative Colitis, Ozanimod, Pediatric

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 High Dose
Arm Type
Experimental
Arm Title
Ozanimod Low Dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ozanimod
Other Intervention Name(s)
RPC1063
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Proportion of participants who achieve clinical remission
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve clinical remission
Time Frame
At Week 10
Title
Proportion of participants who achieve clinical response
Time Frame
At Week 52
Title
Proportion of participants who achieve clinical response
Time Frame
At Week 10
Title
Proportion of participants who achieve symptomatic remission
Time Frame
At Week 10 and Week 52
Title
Time to achievement of symptomatic remission
Time Frame
Up to 6 years
Title
Proportion of participants who achieve endoscopic improvement
Time Frame
At Week 10 and Week 52
Title
Proportion of participants who achieve corticosteroid free remission
Time Frame
At Week 52
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 6 years
Title
Incidence of Serious Adverse Events
Time Frame
Up to 6 years
Title
Incidence of AEs leading to discontinuation from treatment
Time Frame
Up to 6 years
Title
Incidence of AEs of special interest (AESIs)
Time Frame
Up to 6 years
Title
Steady state systemic exposure of ozanimod and CC112273
Time Frame
At Week 18 and throughout the study, up to 70 weeks
Title
Absolute change from baseline in Absolute Lymphocyte Count (ALC)
Time Frame
Up to 6 years
Title
Percent change from baseline in ALC
Time Frame
Up to 6 years

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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center 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 the 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
Local Institution - 0041
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0052
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Loma Linda University Health System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalyan Ray Parashette, Site 0087
Phone
505-274-0704
Facility Name
Cedars-Sinai Medical 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 0074
Phone
310-423-7100
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Moses, Site 0080
Phone
650-721-2250
Facility Name
Local Institution - 0007
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Completed
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmelo Cuffari, Site 0064
Phone
202-476-4000
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regino Gonzalez-Peralta, Site 0075
Phone
352-514-7349
Facility Name
Local Institution - 0016
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Ebach, Site 0049
Phone
319-471-1301
Facility Name
Maine Medical Partners
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Hoffman, Site 0090
Phone
207-662-5522
Facility Name
Local Institution - 0005
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0042
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
Site 0042
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Stephens, Site 0070
Phone
111111
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Samson, Site 0053
Phone
513-518-8949
Facility Name
Local Institution - 0028
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0040
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0023
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Withdrawn
Facility Name
Atrium Health - Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Linville, Site 0047
Phone
330-718-1986
Facility Name
Local Institution - 0036
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Measurable Outcomes Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefany Garrity, Site 0045
Phone
508-523-1571
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Karam, Site 0067
Phone
832-822-3612
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghassan Wahbeh, Site 0060
Phone
111111
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talya Miller, Site 0091
Phone
206-215-2700
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghu Varier, Site 0046
Phone
503-847-4748
Facility Name
Local Institution - 0037
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0085
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 0085
Facility Name
Local Institution - 0086
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0086
Facility Name
Local Institution - 0076
City
Brussels
State/Province
Bruxelles-Capitale, Région De
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0059
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0059
Facility Name
Local Institution - 0056
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0056
Facility Name
Local Institution - 0063
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0061
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0061
Facility Name
Local Institution - 0071
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0083
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0083
Facility Name
Local Institution - 0082
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 0082
Facility Name
CHU de Toulouse - Hôpital des Enfants
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMMANUEL MAS, Site 0058
Phone
0685946782
Facility Name
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remi Duclaux-Loras, Site 0022
Phone
0472357050
Facility Name
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Dupont-Lucas, Site 0030
Phone
+33668354806
Facility Name
Hôpital Universitaire Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Ruemmele, Site 0017
Phone
0615781674
Facility Name
Local Institution - 0073
City
Paris
ZIP/Postal Code
75571
Country
France
Individual Site Status
Withdrawn
Facility Name
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
City
München
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Schwerd, Site 0032
Phone
089 4400 57727
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Laass, Site 0031
Phone
00493514583449
Facility Name
Local Institution - 0020
City
Petah-Tikva
State/Province
HaMerkaz
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0018
City
Haifa
State/Province
HaTsafon
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0019
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9013102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0025
City
Obu
State/Province
Aichi
ZIP/Postal Code
474-8710
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 0011
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
8300011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0068
City
Komatsu
State/Province
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0068
Facility Name
Local Institution - 0038
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2300012
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0021
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0024
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0009
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
1578535
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0033
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0069
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0010
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0012
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-369
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0043
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0043
Facility Name
Local Institution - 0014
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-746
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0084
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0015
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0013
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0079
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0088
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-434
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0088
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Local Institution
City
Moskva
ZIP/Postal Code
119571
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0048
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0051
City
Esplugues de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0044
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0057
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0050
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0054
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0066
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0066
Facility Name
Local Institution - 0026
City
London
State/Province
London, City Of
ZIP/Postal Code
SE5 9RL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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

Learn more about this trial

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

We'll reach out to this number within 24 hrs