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An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

Primary Purpose

Colitis, Ulcerative

Status
Recruiting
Phase
Phase 4
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, RPC-1063, Zeposia®, Inflammatory bowel disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration

  • Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:

    i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).

  • Report of a previous colonoscopy that documents extent of disease

Exclusion Criteria:

  • Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation
  • Extensive colonic resection or current stoma
  • Colonic dysplasia that has not been removed

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • GUT P.C., dba Digestive Health Specialists
  • GUT P.C., dba Digestive Health SpecialistsRecruiting
  • Arizona Gastrointestinal Associates, PLC - Chandler - Advanced GastroenterologyRecruiting
  • Arizona Arthritis & Rheumatology Research, PLLC
  • Arizona Digestive Health: Scottsdale - GI Alliance
  • Texas Digestive Disease Consultants - Sun City - TDDC - PPDSRecruiting
  • University of Arizona
  • Arkansas Gastroenterology
  • Arkansas GastroenterologyRecruiting
  • Om Research, LLC Apple Valley
  • OM Research LLC - Camarillo - ClinEdge - PPDSRecruiting
  • OM Research LLC - Lancaster - ClinEdge - PPDSRecruiting
  • OM Research LLC - Lancaster - ClinEdge - PPDS
  • Southern California Research Institute Medical Group, Inc.
  • United Clinical Research Institute - Clinedge - PPDS
  • Clinical Applications Laboratories Inc
  • Clinical Applications Laboratories IncRecruiting
  • Medical Associates Research Group, Inc.
  • San Jose Gastroenterology - 2340 Montpelier Dr
  • Rocky Mountain Gastroenterology (RMG) - LittletonRecruiting
  • Gastro Florida
  • Gastro FloridaRecruiting
  • Nature Coast Clinical Research
  • Alliance Medical Research LLC
  • Alliance Medical Research LLCRecruiting
  • Wellness Clinical Research-Miami Florida
  • Homestead Associates in Research Inc
  • Homestead Associates in Research Inc
  • University of Miami
  • Gastroenterology Group of Naples
  • Gastroenterology Group of Naples
  • Digestive Disease Consultants, PA
  • Digestive Disease Consultants, PARecruiting
  • Advanced Gastroenterology Associates, LLC
  • Advanced Gastroenterology Associates, LLCRecruiting
  • Gastro Florida- Riverview
  • Bayfront Health St. Petersburg
  • R&B Medical Center
  • Gastroenterology Associates of Florida (GI AlliancRecruiting
  • Atlanta Gastroenterology Associates
  • Gastroenterology Consultants, PC
  • Gastroenterology Consultants, PCRecruiting
  • Northwest Gastroenterologists
  • Feinberg School of Medicine Northwestern UniversityRecruiting
  • Northwestern Medicine Prentice Women's Hospital
  • Rush University Medical Center -1725 W Harrison St
  • University of Chicago Medical Center
  • University of Chicago
  • Illinois Gastroenterology Group- Gurnee (GI Alliance)Recruiting
  • University of Kansas Medical Center
  • Olathe Health
  • Stormont Vail Health CareRecruiting
  • University of Louisville
  • Texas Digestive Disease Consultants - PPDSRecruiting
  • University of Maryland
  • Chevy Chase Clinical ResearchRecruiting
  • Woodholme Gastroenterology AssociatesRecruiting
  • Boston SpecialistsRecruiting
  • UMass Memorial Medical CenterRecruiting
  • MNGI Digestive Health, PARecruiting
  • Digestive Health Center PA
  • Clinical Research Professionals
  • Clinical Research ProfessionalsRecruiting
  • St. Charles Clinical Research, LLC
  • The Gastroenterology Group of Northern NJ LLCRecruiting
  • NYC Health and Hospitals/Kings County Hospital - BRANY - PPDS
  • Vanguard Gastroenterology LLP (Midtown)
  • NYU Langone Health -Inflammatory Bowel Disease Center
  • Weill Cornell Medical College
  • New York Gastroenterology Associates
  • Digestive Disease Medicine of Central New YorkRecruiting
  • Carolina Digestive Diseases
  • Carolina Digestive Diseases
  • Gastroenterology Associates of the Piedmont
  • University of Cincinnati Physicians Company
  • University of Cincinnati Physicians CompanyRecruiting
  • Cleveland Clinic Hospital
  • Optimed Research Ltd - Clinedge - PPDS
  • The Endoscopy Center of Lake County
  • The Endoscopy Center of Lake CountyRecruiting
  • Eastern Pennsylvania Gastroenterology & Liver Specialists, P.C
  • University Gastroenterology
  • University GastroenterologyRecruiting
  • Medical University of South Carolina - PPDS
  • Gastro One-8110 Walnut Run RdRecruiting
  • Nashville Gastrointestinal Specialists Inc
  • Novel Research LLC
  • Novel Research LLCRecruiting
  • Baylor Research InstituteRecruiting
  • Brooke Army Medical Center - DoD - PPDS
  • Digestive Health Associates of Texas - RichardsonRecruiting
  • Digestive Health Associates of TexasRecruiting
  • Ace Clinical Research Group: Digestive Health Associates
  • Houston Methodist Hospital
  • Biopharma Informatic Inc.
  • Katy Integrative GastroenterologyRecruiting
  • Lubbock Digestive Disease AssociatesRecruiting
  • GI Alliance: Mansfield - TDDC
  • GI Alliance: Mansfield - TDDCRecruiting
  • Gastroenterology Research of San Antonio (GERSA)Recruiting
  • San Antonio Gastroenterology
  • San Antonio GastroenterologyRecruiting
  • Texas Digestive Disease Consultants: San Marcos
  • Tyler Research Institute, LLC
  • Tyler Research Institute, LLCRecruiting
  • Texas Digestive Disease Consultants - TDDC - PPDSRecruiting
  • Ogden Clinic Gastrenterology - CARRecruiting
  • University of Utah - PPDS
  • Granite Peaks Gastroenterology
  • Blue Ridge Medical Research
  • Swedish Gastroenterology - First HillRecruiting
  • Washington Gastroenterology - TacomaRecruiting
  • University of Wisconsin Hospital and Clinics
  • University of Wisconsin Hospital and Clinics
  • Wellness Clinical Research - Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1 - Advanced therapy-naive

Cohort 2 - Advanced therapy-exposed

Arm Description

Outcomes

Primary Outcome Measures

Clinical response as measured by modified Mayo score at Week 12
Cohort 1 and 2

Secondary Outcome Measures

Clinical remission as measured by modified Mayo score
Cohort 1 and 2
Proportion of participants who achieve endoscopic response
Cohort 1 and 2
Proportion of participants who achieve endoscopic improvement
Cohort 1 and 2
Proportion of participants who achieve histological improvement
Cohort 1 and 2
Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline
Cohort 1 and 2
Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline
Cohort 1 and 2
Proportion of participants with IBDQ remission with total score of ≥ 170 points
Cohort 1 and 2
Proportion of participants who achieve endoscopic remission
Cohort 2 only
Proportion of participants who achieve histological remission
Cohort 2 only
Corticosteroid-free clinical remission as measured by modified Mayo score
Cohort 2 only
Proportion of participants with histo-endoscopic mucosal improvement
Cohort 2 only
Proportion of participants with Adverse Events (AEs)
Cohort 1 and 2
Proportion of participants with Serious Adverse Events (SAEs)
Cohort 1 and 2
Proportion of participants with AEs of interest (AEI)
Cohort 1 and 2
Proportion of participants with AEs leading to discontinuation
Cohort 1 and 2
Proportion of participants with clinical laboratory abnormalities
Cohort 1 and 2
Clinical remission by partial Mayo score
Cohort 1 and 2
Corticosteroid-free clinical remission by partial Mayo
Cohort 1 and 2
Clinical response by partial Mayo score
Cohort 1 and 2

Full Information

First Posted
May 6, 2022
Last Updated
October 24, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05369832
Brief Title
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
Official Title
A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
November 29, 2024 (Anticipated)
Study Completion Date
April 28, 2027 (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
No

5. Study Description

Brief Summary
The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

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, RPC-1063, Zeposia®, Inflammatory bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
415 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 - Advanced therapy-naive
Arm Type
Experimental
Arm Title
Cohort 2 - Advanced therapy-exposed
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ozanimod
Other Intervention Name(s)
Zeposia®, RPC-1063, BMS-986374
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Clinical response as measured by modified Mayo score at Week 12
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Secondary Outcome Measure Information:
Title
Clinical remission as measured by modified Mayo score
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants who achieve endoscopic response
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants who achieve endoscopic improvement
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants who achieve histological improvement
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants with IBDQ remission with total score of ≥ 170 points
Description
Cohort 1 and 2
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants who achieve endoscopic remission
Description
Cohort 2 only
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants who achieve histological remission
Description
Cohort 2 only
Time Frame
Up to approximately 26 weeks
Title
Corticosteroid-free clinical remission as measured by modified Mayo score
Description
Cohort 2 only
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants with histo-endoscopic mucosal improvement
Description
Cohort 2 only
Time Frame
Up to approximately 26 weeks
Title
Proportion of participants with Adverse Events (AEs)
Description
Cohort 1 and 2
Time Frame
Up to approximately 2 years
Title
Proportion of participants with Serious Adverse Events (SAEs)
Description
Cohort 1 and 2
Time Frame
Up to approximately 2 years
Title
Proportion of participants with AEs of interest (AEI)
Description
Cohort 1 and 2
Time Frame
Up to approximately 2 years
Title
Proportion of participants with AEs leading to discontinuation
Description
Cohort 1 and 2
Time Frame
Up to approximately 2 years
Title
Proportion of participants with clinical laboratory abnormalities
Description
Cohort 1 and 2
Time Frame
Up to approximately 2 years
Title
Clinical remission by partial Mayo score
Description
Cohort 1 and 2
Time Frame
Up to approximately 104 weeks
Title
Corticosteroid-free clinical remission by partial Mayo
Description
Cohort 1 and 2
Time Frame
Up to approximately 104 weeks
Title
Clinical response by partial Mayo score
Description
Cohort 1 and 2
Time Frame
Up to approximately 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores: i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration). Report of a previous colonoscopy that documents extent of disease Exclusion Criteria: Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation Extensive colonic resection or current stoma Colonic dysplasia that has not been removed 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
GUT P.C., dba Digestive Health Specialists
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305-1156
Country
United States
Individual Site Status
Withdrawn
Facility Name
GUT P.C., dba Digestive Health Specialists
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305-1156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Travis Rutland, Site 0048
Facility Name
Arizona Gastrointestinal Associates, PLC - Chandler - Advanced Gastroenterology
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224-1636
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Ahluwalia, Site 0206
Phone
480-733-0500
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297-0425
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Soloman, Site 0216
Phone
623-512-4320
Facility Name
Arizona Digestive Health: Scottsdale - GI Alliance
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85250-7004
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Digestive Disease Consultants - Sun City - TDDC - PPDS
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351-2867
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chirag Trivedi, Site 0125
Phone
623-972-2116
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-0001
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Taleban, Site 0195
Phone
520-626-6453
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117-2927
Country
United States
Individual Site Status
Withdrawn
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117-2927
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Wofford, Site 0045
Facility Name
Om Research, LLC Apple Valley
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307-1329
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neera Grover, Site 0165
Phone
661-338-2239
Facility Name
OM Research LLC - Camarillo - ClinEdge - PPDS
City
Camarillo
State/Province
California
ZIP/Postal Code
93012-5156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Simon, Site 0162
Phone
610-872-7660
Facility Name
OM Research LLC - Lancaster - ClinEdge - PPDS
City
Lancaster
State/Province
California
ZIP/Postal Code
93534-5856
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jatinder Pruthi, Site 0014
Phone
661-388-2239
Facility Name
OM Research LLC - Lancaster - ClinEdge - PPDS
City
Lancaster
State/Province
California
ZIP/Postal Code
93534-5856
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jatinder Pruthi, Site 0086
Phone
661-388-2239
Facility Name
Southern California Research Institute Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045-3119
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adebambo Ojuri, Site 0209
Facility Name
United Clinical Research Institute - Clinedge - PPDS
City
Murrieta
State/Province
California
ZIP/Postal Code
92563-1405
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Applications Laboratories Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103-5639
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Applications Laboratories Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103-5639
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijayalakshmi Pratha, Site 0002
Phone
619-260-1012
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4207
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Kim, Site 0208
Phone
858-277-5678
Facility Name
San Jose Gastroenterology - 2340 Montpelier Dr
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoan Tran, Site 0185
Phone
408-347-9001
Facility Name
Rocky Mountain Gastroenterology (RMG) - Littleton
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-5641
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Springer, Site 0178
Phone
303-279-1550
Facility Name
Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756-3839
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Michael Weiss, Site 0136
Phone
727-347-0536
Facility Name
Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756-3839
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Michael Weiss, Site 0018
Phone
727-347-0536
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452-4705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Alliance Medical Research LLC
City
Lighthouse Point
State/Province
Florida
ZIP/Postal Code
33064-7058
Country
United States
Individual Site Status
Withdrawn
Facility Name
Alliance Medical Research LLC
City
Lighthouse Point
State/Province
Florida
ZIP/Postal Code
33064-7058
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vipin Gupta, Site 0026
Facility Name
Wellness Clinical Research-Miami Florida
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016-5861
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucky Flores, Site 0068
Facility Name
Homestead Associates in Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Withdrawn
Facility Name
Homestead Associates in Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Fernandez, Site 0050
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Abreu, Site 0167
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102-5449
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Phillips, Site 0071
Phone
239-649-1186
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Phillips, Site 0003
Phone
239-649-1186
Facility Name
Digestive Disease Consultants, PA
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073-4752
Country
United States
Individual Site Status
Withdrawn
Facility Name
Digestive Disease Consultants, PA
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073-4752
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Habashi, Site 0058
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Individual Site Status
Withdrawn
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jawahar Taunk, Site 0037
Facility Name
Gastro Florida- Riverview
City
Riverview
State/Province
Florida
ZIP/Postal Code
33578-9498
Country
United States
Individual Site Status
Withdrawn
Facility Name
Bayfront Health St. Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udayakumar Navaneethan, Site 0205
Phone
407-303-2750
Facility Name
R&B Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-1874
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lidia Bermudez, Site 0211
Phone
786-703-3922
Facility Name
Gastroenterology Associates of Florida (GI Allianc
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414-3187
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyle Hurwitz, Site 0179
Phone
561-964-8221
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-5020
Country
United States
Individual Site Status
Withdrawn
Facility Name
Gastroenterology Consultants, PC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076-4969
Country
United States
Individual Site Status
Withdrawn
Facility Name
Gastroenterology Consultants, PC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076-4969
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Riddick, Site 0027
Phone
770-442-5882
Facility Name
Northwest Gastroenterologists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Bernsen, Site 0198
Phone
847-439-1005
Facility Name
Feinberg School of Medicine Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Hanauer, Site 0051
Phone
312-695-8952
Facility Name
Northwestern Medicine Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rush University Medical Center -1725 W Harrison St
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3988
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Rubin, Site 0033
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell Cohen, Site 0172
Phone
000-000-0000
Facility Name
Illinois Gastroenterology Group- Gurnee (GI Alliance)
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Rosenberg, Site 0098
Phone
847-244-2960
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-8500
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shadi Hamdeh, Site 0192
Phone
913-588-6019
Facility Name
Olathe Health
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061-7209
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stormont Vail Health Care
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606-1539
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curtis Baum, Site 0181
Phone
785-368-0738
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Digestive Disease Consultants - PPDS
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809-2440
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Leo, Site 0200
Phone
225-927-1190
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815-7313
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Cohen, Site 0171
Phone
301-652-5520
Facility Name
Woodholme Gastroenterology Associates
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061-9121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenolisa Onwueme, Site 0191
Facility Name
Boston Specialists
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1924
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Leung, Site 0199
Phone
617-636-2379
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abbas Rupawala, Site 0196
Facility Name
MNGI Digestive Health, PA
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446-3661
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Mccabe, Site 0174
Phone
612-871-1145
Facility Name
Digestive Health Center PA
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564-5803
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred McNair, Jr., Site 0184
Phone
228-872-7612
Facility Name
Clinical Research Professionals
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141-7146
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Professionals
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141-7146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Fern, Site 0024
Phone
636-246-3999
Facility Name
St. Charles Clinical Research, LLC
City
Weldon Spring
State/Province
Missouri
ZIP/Postal Code
63304-9103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikhil Banerjee, Site 0213
Phone
314-279-8200
Facility Name
The Gastroenterology Group of Northern NJ LLC
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631-4141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Rubin, Site 0180
Phone
201-569-7044
Facility Name
NYC Health and Hospitals/Kings County Hospital - BRANY - PPDS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203-2054
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaniuska Lescaille, Site 0084
Phone
718-245-3838
Facility Name
Vanguard Gastroenterology LLP (Midtown)
City
New York
State/Province
New York
ZIP/Postal Code
10016-6821
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Oneto Araya, Site 0187
Phone
212-889-5544
Facility Name
NYU Langone Health -Inflammatory Bowel Disease Center
City
New York
State/Province
New York
ZIP/Postal Code
10016-9401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hudesman, Site 0069
Phone
212-263-3096
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Scherl, Site 0176
Facility Name
New York Gastroenterology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10075-0999
Country
United States
Individual Site Status
Withdrawn
Facility Name
Digestive Disease Medicine of Central New York
City
Utica
State/Province
New York
ZIP/Postal Code
13502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harvey Allen, Site 0170
Phone
315-624-7000
Facility Name
Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834-3761
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Goldstein, Site 0140
Phone
252-758-8182
Facility Name
Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834-3761
Country
United States
Individual Site Status
Withdrawn
Facility Name
Gastroenterology Associates of the Piedmont
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-3914
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Cincinnati Physicians Company
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3019
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loren Brook, Site 0108
Facility Name
University of Cincinnati Physicians Company
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loren Brook, Site 0005
Facility Name
Cleveland Clinic Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Individual Site Status
Withdrawn
Facility Name
Optimed Research Ltd - Clinedge - PPDS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235-5424
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald McNeil, Site 0188
Phone
614-505-3030
Facility Name
The Endoscopy Center of Lake County
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6521
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Endoscopy Center of Lake County
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060-6521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keyur Parikh, Site 0061
Phone
440-205-1225
Facility Name
Eastern Pennsylvania Gastroenterology & Liver Specialists, P.C
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104-2309
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905-3105
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905-3105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheldon Lidofsky, Site 0060
Phone
888-888-8888
Facility Name
Medical University of South Carolina - PPDS
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Forster, Site 0160
Phone
843-876-0783
Facility Name
Gastro One-8110 Walnut Run Rd
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziad Younes, Site 0177
Phone
901-309-6035
Facility Name
Nashville Gastrointestinal Specialists Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211-4981
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Pointer, Site 0168
Phone
615-835-4752
Facility Name
Novel Research LLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Everald Manning, Site 0113
Facility Name
Novel Research LLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Everald Manning, Site 0038
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Themistocles Dassopoulos, Site 0138
Facility Name
Brooke Army Medical Center - DoD - PPDS
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-4504
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anish Patel, Site 0190
Phone
000-000-0000
Facility Name
Digestive Health Associates of Texas - Richardson
City
Houston
State/Province
Texas
ZIP/Postal Code
77024-2469
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Sarles, Site 0163
Phone
214-274-5464
Facility Name
Digestive Health Associates of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77024-2469
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gowrappala Ramesh, Site 0036
Facility Name
Ace Clinical Research Group: Digestive Health Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gowrappala Ramesh, Site 0090
Facility Name
Houston Methodist 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
Bincy Abraham, Site 0083
Phone
713-441-0006
Facility Name
Biopharma Informatic Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77043-2742
Country
United States
Individual Site Status
Withdrawn
Facility Name
Katy Integrative Gastroenterology
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radha Tamerisa, Site 0129
Phone
281-944-3610
Facility Name
Lubbock Digestive Disease Associates
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-2014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Hughston, Site 0161
Phone
806-743-3141
Facility Name
GI Alliance: Mansfield - TDDC
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063-6083
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moustafa Youssef, Site 0067
Facility Name
GI Alliance: Mansfield - TDDC
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063-6083
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moustafa Youssef, Site 0039
Facility Name
Gastroenterology Research of San Antonio (GERSA)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3270
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell Havranek, Site 0201
Phone
210-615-3848
Facility Name
San Antonio Gastroenterology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4463
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Bullock, Site 0144
Phone
210-581-2812
Facility Name
San Antonio Gastroenterology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4463
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Bullock, Site 0043
Phone
210-581-2812
Facility Name
Texas Digestive Disease Consultants: San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666-7502
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Marek, Site 0166
Phone
512-754-8676
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Du Vall, Site 0128
Phone
903-595-5101
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Du Vall, Site 0046
Phone
903-595-5101
Facility Name
Texas Digestive Disease Consultants - TDDC - PPDS
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sezen Altug, Site 0091
Phone
832-905-5001
Facility Name
Ogden Clinic Gastrenterology - CAR
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403-3294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Gonzales, Site 0193
Facility Name
University of Utah - PPDS
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Johnson, Site 0169
Facility Name
Granite Peaks Gastroenterology
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092-4350
Country
United States
Individual Site Status
Withdrawn
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502-4272
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larry Clark, Site 0197
Phone
434-455-8675
Facility Name
Swedish Gastroenterology - First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-1356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Chiorean, Site 0130
Phone
206-625-7373
Facility Name
Washington Gastroenterology - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-2318
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Holderman, Site 0189
Phone
253-503-2547
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-1311
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freddy Caldera, Site 0017
Phone
608-262-5404
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freddy Caldera, Site 0151
Phone
608-262-5404
Facility Name
Wellness Clinical Research - Puerto Rico
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico
Individual Site Status
Withdrawn

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

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

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