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Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

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

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.

Exclusion Criteria:

  • Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
  • Evidence of active tuberculosis (TB)

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0077
  • Local Institution - 0030
  • Local Institution - 0049
  • Local Institution - 0074
  • Local Institution - 0115
  • Local Institution - 0044
  • Local Institution - 0140
  • Local Institution - 0133
  • Local Institution - 0032
  • Local Institution - 0048
  • The Emory Clinic
  • Local Institution - 0050
  • Local Institution - 0123
  • Local Institution - 0131
  • Local Institution - 0071
  • Local Institution - 0031
  • Local Institution - 0064
  • Local Institution - 0035
  • Local Institution - 0121
  • Local Institution - 0001
  • Local Institution - 0041
  • Tekton Research - Austin
  • University of Texas Southwestern Medical Center
  • Local Institution - 0037
  • Local Institution - 0046
  • Clinica Adventista Belgrano
  • Local Institution - 0125
  • Local Institution - 0098
  • Centro Medico Privado de Reumatologia
  • Local Institution - 0100
  • Local Institution - 0122
  • Local Institution - 0095
  • Local Institution - 0116
  • Local Institution - 0118
  • Local Institution - 0106
  • Local Institution - 0120
  • Local Institution - 0107
  • Local Institution - 0111
  • Local Institution - 0105
  • University of Calgary
  • Local Institution - 0136
  • Local Institution - 0108
  • Centro de Investigacion en Reumatologia y Especialidades Medicas
  • Local Institution - 0103
  • Local Institution - 0096
  • Local Institution - 0039
  • Local Institution - 0038
  • Local Institution - 0045
  • National Hospital Organization Chibahigashi National Hospital
  • Local Institution - 0092
  • Sapporo City General Hospital
  • Hokkaido University Hospital
  • Local Institution - 0063
  • Local Institution - 0069
  • Local Institution - 0065
  • Juntendo University Hospital
  • Local Institution - 0066
  • Local Institution - 0093
  • Local Institution
  • Local Institution - 0053
  • Local Institution - 0087
  • Local Institution - 0080
  • Centro de Investigacion Farmacologica del Bajio
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
  • Accelerium Clinical Research
  • Local Institution - 0082
  • Local Institution - 0025
  • Local Institution - 0015
  • Local Institution - 0014
  • Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia
  • Centrum Medyczne ProMiMed
  • Local Institution - 0016
  • Local Institution - 0024
  • Local Institution - 0029
  • Local Institution - 0019
  • Local Institution - 0022
  • Local Institution - 0010
  • Local Institution - 0023
  • Local Institution - 0033
  • Local Institution - 0004
  • Local Institution - 0002
  • Local Institution - 0061
  • Local Institution - 0056
  • Local Institution - 0072
  • Local Institution - 0057
  • Local Institution - 0062
  • Local Institution - 0070
  • Local Institution - 0058
  • Local Institution - 0055
  • Local Institution - 0068
  • Local Institution - 0060
  • Hospital Regional Universitario de Malaga Hospital General
  • Local Institution - 0138
  • Local Institution - 0124
  • Local Institution - 0052
  • Local Institution
  • Local Institution - 0051
  • Local Institution - 0137

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BMS-986165 Dose 1

BMS-986165 Dose 2

BMS-986165 Dose 3

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs)
Number of participants with AEs leading to discontinuation
Number of participants with abnormal change from baseline in laboratory measurements over time
Number of participants with abnormal change from baseline in vital signs over time

Secondary Outcome Measures

Full Information

First Posted
March 27, 2019
Last Updated
September 26, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03920267
Brief Title
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
Official Title
A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (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 main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants who successfully complete the protocol-required treatment period of the Phase 2 SLE study (NCT03252587) will be offered the opportunity to continue this study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165 Dose 1
Arm Type
Experimental
Arm Title
BMS-986165 Dose 2
Arm Type
Experimental
Arm Title
BMS-986165 Dose 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Other Intervention Name(s)
Deucravacitinib
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs)
Time Frame
Up to 30 days after last treatment dose (approximately 178 weeks)
Title
Number of participants with Serious Adverse Events (SAEs)
Time Frame
Up to 30 days after last treatment dose (approximately 178 weeks)
Title
Number of participants with AEs leading to discontinuation
Time Frame
Up to 30 days after last treatment dose (approximately 178 weeks)
Title
Number of participants with abnormal change from baseline in laboratory measurements over time
Time Frame
Up to 30 days after last treatment dose (approximately 178 weeks)
Title
Number of participants with abnormal change from baseline in vital signs over time
Time Frame
Up to 30 days after last treatment dose (approximately 178 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee. Exclusion Criteria: Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason Evidence of active tuberculosis (TB) 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
Local Institution - 0077
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1913
Country
United States
Facility Name
Local Institution - 0030
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Local Institution - 0049
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Local Institution - 0074
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 0115
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Local Institution - 0044
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Local Institution - 0140
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32603
Country
United States
Facility Name
Local Institution - 0133
City
Orlando
State/Province
Florida
ZIP/Postal Code
32835
Country
United States
Facility Name
Local Institution - 0032
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174-1139
Country
United States
Facility Name
Local Institution - 0048
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Local Institution - 0050
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Local Institution - 0123
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Local Institution - 0131
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0071
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7280
Country
United States
Facility Name
Local Institution - 0031
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 0064
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Local Institution - 0035
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Local Institution - 0121
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0001
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Local Institution - 0041
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-3146
Country
United States
Facility Name
Tekton Research - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Local Institution - 0037
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Local Institution - 0046
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Clinica Adventista Belgrano
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Local Institution - 0125
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1046
Country
Argentina
Facility Name
Local Institution - 0098
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel De Tucum
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Local Institution - 0100
City
Caba
ZIP/Postal Code
1111
Country
Argentina
Facility Name
Local Institution - 0122
City
Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Local Institution - 0095
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Local Institution - 0116
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150150
Country
Brazil
Facility Name
Local Institution - 0118
City
Goiߡ
State/Province
Goias
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Local Institution - 0106
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Local Institution - 0120
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Local Institution - 0107
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Local Institution - 0111
City
Sao Bernardo do Campo
State/Province
SAO Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Local Institution - 0105
City
Sao Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Local Institution - 0136
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Local Institution - 0108
City
Barranquilla
ZIP/Postal Code
0
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas
City
Bogot
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Local Institution - 0103
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Local Institution - 0096
City
Zipaquira
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Local Institution - 0039
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution - 0038
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Local Institution - 0045
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
National Hospital Organization Chibahigashi National Hospital
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Local Institution - 0092
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Sapporo City General Hospital
City
Sapporo-Shi
State/Province
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Local Institution - 0063
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Local Institution - 0069
City
Shimotsuke-city
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Local Institution - 0065
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Local Institution - 0066
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Local Institution - 0093
City
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Local Institution - 0053
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Local Institution - 0087
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Local Institution - 0080
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro de Investigacion Farmacologica del Bajio
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37160
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Accelerium Clinical Research
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Local Institution - 0082
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Local Institution - 0025
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution - 0015
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Local Institution - 0014
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Centrum Medyczne ProMiMed
City
Krak
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Local Institution - 0016
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Local Institution - 0024
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Local Institution - 0029
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Local Institution - 0019
City
Warsaw
ZIP/Postal Code
02-172
Country
Poland
Facility Name
Local Institution - 0022
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Local Institution - 0010
City
Wroclaw
ZIP/Postal Code
50-363
Country
Poland
Facility Name
Local Institution - 0023
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Local Institution - 0033
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Local Institution - 0004
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
Local Institution - 0002
City
Ramnicu Valcea
ZIP/Postal Code
240277
Country
Romania
Facility Name
Local Institution - 0061
City
Ekaterinburg
ZIP/Postal Code
620043
Country
Russian Federation
Facility Name
Local Institution - 0056
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Local Institution - 0072
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Local Institution - 0057
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
Local Institution - 0062
City
Saint - Petersburg
ZIP/Postal Code
191045
Country
Russian Federation
Facility Name
Local Institution - 0070
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
Local Institution - 0058
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Local Institution - 0055
City
Vladimir
ZIP/Postal Code
600005
Country
Russian Federation
Facility Name
Local Institution - 0068
City
Yaroslavl
ZIP/Postal Code
150023
Country
Russian Federation
Facility Name
Local Institution - 0060
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Hospital Regional Universitario de Malaga Hospital General
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0138
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Local Institution - 0124
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Local Institution - 0052
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Local Institution
City
Taipei City
ZIP/Postal Code
10630
Country
Taiwan
Facility Name
Local Institution - 0051
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 0137
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

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

Learn more about this trial

Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

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