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Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986165
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
  • Must have documented diagnosis of UC of at least 3 months' duration prior to screening
  • Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

Exclusion Criteria:

  • Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
  • Stool positive for C. difficile toxin at screening visit
  • Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Connecticut Clinical Research Foundation
  • University of Florida
  • University of Florida
  • Local Institution - 0048
  • Local Institution - 0044
  • Local Institution - 0011
  • Local Institution - 0121
  • Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
  • Local Institution - 0018
  • Local Institution - 0047
  • Infusion Associates
  • Mayo Clinic - Rochester
  • Local Institution - 0002
  • Local Institution - 0049
  • New York University Langone Medical Center
  • Consultants for Clinical Research
  • Penn State Health Milton S. Hershey Medical Center
  • University of Pittsburgh Medical Center
  • Local Institution - 0074
  • Rapid City Medical Center
  • Gastro One
  • Vanderbilt University Medical Center
  • Local Institution - 0097
  • Local Institution - 0008
  • Gastroenterology Research of San Antonio
  • Local Institution - 0106
  • Texas Digestive Disease Consultants - Southlake
  • Local Institution - 0116
  • Virginia Mason Medical Center
  • Swedish First Hill Campus
  • The Vancouver Clinic
  • Princess Alexandra Hospital
  • Local Institution - 0071
  • Local Institution - 0108
  • Fiona Stanley Hospital
  • Local Institution - 0039
  • Local Institution - 0065
  • Clinique du MontLegia - CHC
  • Hepato-Gastroenterology HK
  • Nemocnice Slany
  • Centre Hospitalier Universitaire de Montpellier
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
  • Local Institution
  • Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
  • Universitatsklinikum Carl Gustav Carus Dresden
  • Medizinische Hochschule Hannover
  • Local Institution - 0070
  • Local Institution - 0062
  • Universitatsklinik Ulm
  • Magyar Honvedseg-Egeszsegugyi Kozpont
  • Local Institution - 0042
  • Local Institution - 0024
  • Debreceni Egyetem Klinikai Kozpont
  • Bugat Pal Korhaz
  • Local Institution - 0033
  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
  • Local Institution - 0005
  • Clinica Medica Azienda Ospedaliera Universitaria
  • Azienda Ospedaliera di Padova
  • Local Institution - 0027
  • Policlinico Universitario Campus Bio-Medico
  • Local Institution - 0046
  • Fondazione Policlinico Universitario Agostino Gemelli
  • National Hospital Organization Hirosaki National Hospital
  • Fukuoka University Chikushi Hospital
  • Local Institution - 0078
  • National Hospital Organization Takasaki General Medical Center
  • Hyogo College of Medicine Hospital
  • Local Institution - 0081
  • Shiga University of Medical Science Hospital
  • Local Institution - 0066
  • Local Institution - 0080
  • Saga University Hospital
  • Local Institution - 0064
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0091
  • Local Institution - 0013
  • Local Institution - 0100
  • Local Institution - 0045
  • Local Institution - 0098
  • Local Institution - 0094
  • Local Institution - 0040
  • Local Institution - 0053
  • Local Institution - 0014
  • Centrum Zdrowia Matki Dziecka i Mlodziezy
  • Local Institution - 0088
  • Local Institution - 0095
  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
  • Local Institution - 0030
  • Local Institution - 0037
  • Centrum Medyczne Oporow
  • Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
  • Local Institution - 0020
  • Novosibirsk State Regional Clinical Hospital
  • Local Institution - 0092
  • Local Institution - 0015
  • Multidisciplinary Consultative and Diagnostic Center
  • Barnsley Hospital NHS Foundation Trust
  • Local Institution - 0031
  • NHS Greater Glasgow and Clyde
  • Imperial College Healthcare NHS Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BMS-986165

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Clinical Remission Response Rate at Week 12
Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) subscore ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) subscore = 0, and Endoscopic (ES) subscoreb ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES subscores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual subscore greater than 1

Secondary Outcome Measures

Clinical Response Rate at 12 Weeks
Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1
Endoscopic Response at Week 12
Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern: Normal (score 0) patchy obliteration (score 1) Obliterated (score 2) Bleeding None (score 0) Mucosal (score 1) Luminal mild (score 2) Luminal Moderate or severe (score 3) Erosions and Ulcers None (score 0) Erosions ( score 1) Superficial Ulcer (2) Deep Ulcer (score 3) A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).
Histological Improvement Response Rate at 12 Weeks
Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score: Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or < 5% crypts involved), and Score of 0 for Grade 4 (crypt destruction: none), and Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue) grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease

Full Information

First Posted
April 30, 2019
Last Updated
April 25, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03934216
Brief Title
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 13, 2021 (Actual)
Study Completion Date
April 4, 2023 (Actual)

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 assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Other Intervention Name(s)
Deucravacitinib
Intervention Description
Specified Dose on Specified Days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Clinical Remission Response Rate at Week 12
Description
Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) subscore ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) subscore = 0, and Endoscopic (ES) subscoreb ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES subscores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual subscore greater than 1
Time Frame
From first dose to 12 weeks.
Secondary Outcome Measure Information:
Title
Clinical Response Rate at 12 Weeks
Description
Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1
Time Frame
From first dose to 12 weeks
Title
Endoscopic Response at Week 12
Description
Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern: Normal (score 0) patchy obliteration (score 1) Obliterated (score 2) Bleeding None (score 0) Mucosal (score 1) Luminal mild (score 2) Luminal Moderate or severe (score 3) Erosions and Ulcers None (score 0) Erosions ( score 1) Superficial Ulcer (2) Deep Ulcer (score 3) A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).
Time Frame
up to 12 Weeks
Title
Histological Improvement Response Rate at 12 Weeks
Description
Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score: Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or < 5% crypts involved), and Score of 0 for Grade 4 (crypt destruction: none), and Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue) grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease
Time Frame
up to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit Must have documented diagnosis of UC of at least 3 months' duration prior to screening Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2 Exclusion Criteria: Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile]) Stool positive for C. difficile toxin at screening visit Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation Other protocol-defined inclusion/exclusion criteria apply
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
Connecticut Clinical Research Foundation
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0316
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Local Institution - 0048
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Local Institution - 0044
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Local Institution - 0011
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Local Institution - 0121
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Local Institution - 0018
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Local Institution - 0047
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Infusion Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 0002
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Local Institution - 0049
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45218
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Local Institution - 0074
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Rapid City Medical Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0097
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Local Institution - 0008
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Gastroenterology Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Local Institution - 0106
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Local Institution - 0116
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
The Vancouver Clinic
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution - 0071
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Local Institution - 0108
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 0039
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
Local Institution - 0065
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Clinique du MontLegia - CHC
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Hepato-Gastroenterology HK
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Centre Hospitalier Universitaire de Montpellier
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Local Institution
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0070
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution - 0062
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitatsklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Magyar Honvedseg-Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Local Institution - 0042
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Local Institution - 0024
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Local Institution - 0033
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
City
Bologna
ZIP/Postal Code
40126
Country
Italy
Facility Name
Local Institution - 0005
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Clinica Medica Azienda Ospedaliera Universitaria
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0027
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Local Institution - 0046
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
National Hospital Organization Hirosaki National Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Local Institution - 0078
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
3700829
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Local Institution - 0081
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
2520375
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Local Institution - 0066
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Local Institution - 0080
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Local Institution - 0064
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Local Institution - 0091
City
Bydgoszcz
ZIP/Postal Code
85-231
Country
Poland
Facility Name
Local Institution - 0013
City
Bydgoszcz
ZIP/Postal Code
85-794
Country
Poland
Facility Name
Local Institution - 0100
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Local Institution - 0045
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Local Institution - 0098
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Local Institution - 0094
City
Piotrkow Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
Local Institution - 0040
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Local Institution - 0053
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Local Institution - 0014
City
Tychy
ZIP/Postal Code
43 100
Country
Poland
Facility Name
Centrum Zdrowia Matki Dziecka i Mlodziezy
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Local Institution - 0088
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Local Institution - 0095
City
Warszawa
ZIP/Postal Code
02-798
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Local Institution - 0030
City
Warszawa
ZIP/Postal Code
03-712
Country
Poland
Facility Name
Local Institution - 0037
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
54-416
Country
Poland
Facility Name
Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Local Institution - 0020
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
Novosibirsk State Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Local Institution - 0092
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Local Institution - 0015
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Multidisciplinary Consultative and Diagnostic Center
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Local Institution - 0031
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

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/us/en/home.html
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

Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

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