Back to resultsA Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Deucravacitinib
Placebo matching deucravacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Adolescent Psoriasis, BMS-986165, Clinical trial, Deucravacitinib, Pediatric, Pediatric Psoriasis, Plaque Psoriasis, Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Males and females aged 12 to <18 years
- Plaque psoriasis for at least 6 months
- Moderate to severe disease
- Candidate for phototherapy or systemic therapy
- Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period
Exclusion Criteria:
- Weighing ≤ 30.0 kg at screening
- Other forms of psoriasis
- History of recent infection
- Prior exposure to deucravacitinib (BMS-986165) or active comparator
- Evidence of active TB for LTE period
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Local Institution - 0045
- Local Institution - 0042
- Local Institution - 0044
- Local Institution - 0058
- Local Institution - 0043
- The Skin HospitalRecruiting
- Local Institution - 0002
- Veracity Clinical ResearchRecruiting
- Monash HealthRecruiting
- Local Institution - 0001
- Local Institution - 0010Recruiting
- Local Institution - 0037Recruiting
- Local Institution - 0039
- Local Institution - 0008Recruiting
- Local Institution - 0050
- Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatologyRecruiting
- Centre Hospitalier Universitaire de Nice - Hôpital l'ArchetRecruiting
- Hopital Robert DebreRecruiting
- Local Institution - 0033Recruiting
- Local Institution - 0032Recruiting
- Local Institution - 0040
- Local Institution - 0038Recruiting
- Local Institution - 0034Recruiting
- Local Institution - 0041Recruiting
- Local Institution - 0035Recruiting
- Local Institution - 0048Recruiting
- Local Institution - 0047
- Local Institution - 0059Recruiting
- Local Institution - 0052
- Local Institution - 0054
- Local Institution - 0057
- Local Institution - 0053
- Local Institution - 0011Recruiting
- Local Institution - 0006Recruiting
- Local Institution - 0004Recruiting
- Local Institution - 0005Recruiting
- Local InstitutionRecruiting
- Local InstitutionRecruiting
- Local InstitutionRecruiting
- Local Institution - 0016Recruiting
- Local InstitutionRecruiting
- Local Institution - 0022Recruiting
- Local Institution - 0029
- Local Institution - 0019Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Active treatment deucravacitinib standard dose
Active treatment deucravacitinib half-standard dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
Part A
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
Part A
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2
Part A
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16
Part B
Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
Part B
Incidence of Adverse Events (AEs)
Long-term extension (LTE) Period
Incidence of serious adverse events (SAEs)
LTE Period
Monitoring of growth: Body weight
LTE Period
Monitoring of growth: Height
LTE Period
Monitoring of growth: Tanner staging (sexual maturation)
LTE Period
Secondary Outcome Measures
Incidence of Adverse Events (AEs)
Part A and Part B
Incidence of serious adverse events (SAEs)
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests
Part A and Part B
Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only
Part A and Part B
Incidence of clinically significant changes in lymphocyte subsets and function
Part A and Part B
Incidence of clinically significant changes in cytokine levels
Part A and Part B
Incidence of clinically significant changes in physical examination findings
Part A and Part B
Incidence of clinically significant changes in vital signs: Body temperature
Part A and Part B
Incidence of clinically significant changes in vital signs: Respiratory rate
Part A and Part B
Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure
Part A and Part B
Incidence of clinically significant changes in vital signs: Heart rate
Part A and Part B
Monitoring of growth: Body weight
Part A and Part B
Monitoring of growth: Height
Part A and Part B
Monitoring of growth: Tanner staging (sexual maturation)
Part A and Part B
Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
Part B
Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
Part B
Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo
Part B
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo
Part B
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo
Part B
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo
Part B
Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
Part B
Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
Part B
Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline
Part B
ACR Pedi 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by > 30% for comparison of deucravacitinib vs placebo
Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo
Part B
Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16
Part B
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16
Part B
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16
Part B
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16
Part B
Proportion of participants with 75% improvement in PASI (PASI 75) over time
LTE Period
Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time
LTE Period
Full Information
NCT ID
NCT04772079
First Posted
February 24, 2021
Last Updated
September 29, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT04772079
Brief Title
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Official Title
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
September 9, 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 pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to <18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Adolescent Psoriasis, BMS-986165, Clinical trial, Deucravacitinib, Pediatric, Pediatric Psoriasis, Plaque Psoriasis, Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment deucravacitinib standard dose
Arm Type
Experimental
Arm Title
Active treatment deucravacitinib half-standard dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo matching deucravacitinib
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
Description
Part A
Time Frame
Week 2
Title
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
Description
Part A
Time Frame
Week 2
Title
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2
Description
Part A
Time Frame
Week 2
Title
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16
Description
Part B
Time Frame
Week 16
Title
Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
Description
Part B
Time Frame
Week 16
Title
Incidence of Adverse Events (AEs)
Description
Long-term extension (LTE) Period
Time Frame
Up to 316 weeks
Title
Incidence of serious adverse events (SAEs)
Description
LTE Period
Time Frame
Up to 316 weeks
Title
Monitoring of growth: Body weight
Description
LTE Period
Time Frame
Up to 316 weeks
Title
Monitoring of growth: Height
Description
LTE Period
Time Frame
Up to 316 weeks
Title
Monitoring of growth: Tanner staging (sexual maturation)
Description
LTE Period
Time Frame
Up to 316 weeks
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Description
Part A and Part B
Time Frame
Up to 424 days
Title
Incidence of serious adverse events (SAEs)
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests
Description
Part A and Part B
Time Frame
Up to 410 days
Title
Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests
Description
Part A and Part B
Time Frame
Up to 42 days
Title
Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests
Description
Part A and Part B
Time Frame
Up to 42 days
Title
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Description
Part A and Part B
Time Frame
Up to 368 days
Title
Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests
Description
Part A and Part B
Time Frame
Up to 368 days
Title
Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests
Description
Part A and Part B
Time Frame
Up to 368 days
Title
Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in lymphocyte subsets and function
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in cytokine levels
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in physical examination findings
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in vital signs: Body temperature
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Incidence of clinically significant changes in vital signs: Heart rate
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Monitoring of growth: Body weight
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Monitoring of growth: Height
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Monitoring of growth: Tanner staging (sexual maturation)
Description
Part A and Part B
Time Frame
Up to 466 days
Title
Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline
Description
Part B
ACR Pedi 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by > 30% for comparison of deucravacitinib vs placebo
Time Frame
Week 16
Title
Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo
Description
Part B
Time Frame
Week 16
Title
Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16
Description
Part B
Time Frame
Week 16
Title
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16
Description
Part B
Time Frame
Week 16
Title
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16
Description
Part B
Time Frame
Week 16
Title
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16
Description
Part B
Time Frame
Week 16
Title
Proportion of participants with 75% improvement in PASI (PASI 75) over time
Description
LTE Period
Time Frame
Up to 316 weeks
Title
Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time
Description
LTE Period
Time Frame
Up to 316 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females aged 12 to <18 years for Cohort 1. Males and females aged 4 to <12 years for Cohort 2.
Plaque psoriasis for at least 6 months
Moderate to severe disease
Candidate for phototherapy or systemic therapy
Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period
Exclusion Criteria:
Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to < 18 years), Part A and Part B. Participants weighing ≤ 13.0 kg at screening for Cohort 2 (age 4 to < 12 years), Part A and Part B.
Other forms of psoriasis
History of recent infection
Prior exposure to deucravacitinib (BMS-986165) or active comparator
Evidence of active TB for LTE period
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 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 - 0045
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0045
Facility Name
Local Institution - 0042
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEA
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0042
Facility Name
Local Institution - 0044
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1056
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0058
City
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0043
City
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0043
Facility Name
The Skin Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Kuchel, Site 0020
Phone
61286512027
Facility Name
Local Institution - 0002
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Spelman, Site 0003
Phone
+61419720078
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niyati Sharma, Site 0046
Phone
0451919303
Facility Name
Local Institution - 0001
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3995
Country
Australia
Individual Site Status
Completed
Facility Name
Local Institution - 0010
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0037
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0039
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0008
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution - 0050
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 0050
Facility Name
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertille Bonniaud, Site 0028
Phone
33380293336
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hubiche, Site 0012
Phone
+33492036667
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle BOURRAT, Site 0021
Phone
01 42 49 45 41
Facility Name
Local Institution - 0033
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0032
City
Fukuoka, Jonan-Ku
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0040
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0038
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0034
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0041
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 0041
Facility Name
Local Institution - 0035
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0048
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0047
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
Local Institution - 0059
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0059
Facility Name
Local Institution - 0052
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0054
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0057
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44638
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0053
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0011
City
Krakow
ZIP/Postal Code
30-438
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0006
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0004
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0005
City
Wroclaw
ZIP/Postal Code
51-620
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution
City
Esplugues de Llobregat
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0016
City
Las Palmas De GC
ZIP/Postal Code
35019
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0022
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0029
City
London
State/Province
London, City Of
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0019
City
Connor Downs
ZIP/Postal Code
TR27 5DT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
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
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
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