Clinical trial NCT03920267: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 30 days after last treatment dose (approximately 178 weeks)
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 30 days after last treatment dose (approximately 178 weeks)
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 30 days after last treatment dose (approximately 178 weeks)
measure: Number of participants with abnormal change from baseline in laboratory measurements over time
timeFrame: Up to 30 days after last treatment dose (approximately 178 weeks)
measure: Number of participants with abnormal change from baseline in vital signs over time
timeFrame: Up to 30 days after last treatment dose (approximately 178 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0077
state: Alabama
city: El Cajon
country: United States
facility: Local Institution - 0030
state: California
city: Torrance
country: United States
facility: Local Institution - 0049
state: California
city: New Haven
country: United States
facility: Local Institution - 0074
state: Connecticut
city: Aventura
country: United States
facility: Local Institution - 0115
state: Florida
city: Brandon
country: United States
facility: Local Institution - 0044
state: Florida
city: Gainesville
country: United States
facility: Local Institution - 0140
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0133
state: Florida
city: Ormond Beach
country: United States
facility: Local Institution - 0032
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0048
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0094
state: Georgia
city: Lawrenceville
country: United States
facility: Local Institution - 0050
state: Georgia
city: Brooklyn
country: United States
facility: Local Institution - 0123
state: New York
city: New York
country: United States
facility: Local Institution - 0131
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 0071
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 0031
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution - 0064
state: Oklahoma
city: Wyomissing
country: United States
facility: Local Institution - 0035
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0121
state: South Carolina
city: Jackson
country: United States
facility: Local Institution - 0001
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0041
state: Texas
city: Austin
country: United States
facility: Tekton Research - Austin
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0114
state: Texas
city: Houston
country: United States
facility: Local Institution - 0037
state: Texas
city: Mesquite
country: United States
facility: Local Institution - 0046
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0125
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution - 0098
state: Santa Fe
city: San Miguel De Tucum
country: Argentina
facility: Local Institution - 0091
state: Tucuman
city: Caba
country: Argentina
facility: Local Institution - 0100
city: Cordoba
country: Argentina
facility: Local Institution - 0122
city: Mendoza
country: Argentina
facility: Local Institution - 0095
city: Salvador
country: Brazil
facility: Local Institution - 0116
state: Bahia
city: Goiߡ
country: Brazil
facility: Local Institution - 0118
state: Goias
city: Juiz de Fora
country: Brazil
facility: Local Institution - 0106
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0120
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution - 0107
state: RIO Grande DO SUL
city: Sao Bernardo do Campo
country: Brazil
facility: Local Institution - 0111
state: SAO Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0105
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Toronto
country: Canada
facility: Local Institution - 0136
state: Ontario
city: Barranquilla
country: Colombia
facility: Local Institution - 0108
city: Bogot
country: Colombia
facility: Local Institution - 0101
city: Chia
country: Colombia
facility: Local Institution - 0103
city: Zipaquira
country: Colombia
facility: Local Institution - 0096
city: Debrecen
country: Hungary
facility: Local Institution - 0039
city: Gyula
country: Hungary
facility: Local Institution - 0038
city: Szeged
country: Hungary
facility: Local Institution - 0045
city: Chiba-shi
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
state: Chiba
city: Kitakyushu
country: Japan
facility: Local Institution - 0092
state: Fukuoka
city: Sapporo-Shi
country: Japan
facility: Local Institution - 0119
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sendai
country: Japan
facility: Local Institution - 0063
state: Miyagi
city: Shimotsuke-city
country: Japan
facility: Local Institution - 0069
state: Tochigi
city: Chuo-ku
country: Japan
facility: Local Institution - 0065
state: Tokyo
city: Tokyo
country: Japan
facility: Local Institution - 0078
city: Tokyo
country: Japan
facility: Local Institution - 0066
city: Tokyo
country: Japan
facility: Local Institution - 0093
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution - 0053
city: Mexico City
country: Mexico
facility: Local Institution - 0087
state: Distrito Federal
city: Leon
country: Mexico
facility: Local Institution - 0080
state: Guanajuato
city: Leon
country: Mexico
facility: Local Institution - 0086
state: Guanajuato
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0084
state: Nuevo LEON
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0082
city: Bydgoszcz
country: Poland
facility: Local Institution - 0025
city: Koscian
country: Poland
facility: Local Institution - 0015
city: Krakow
country: Poland
facility: Local Institution - 0014
city: Krakow
country: Poland
facility: Local Institution - 0027
city: Krakow
country: Poland
facility: Local Institution - 0018
city: Lublin
country: Poland
facility: Local Institution - 0016
city: Poznan
country: Poland
facility: Local Institution - 0024
city: Sosnowiec
country: Poland
facility: Local Institution - 0029
city: Warsaw
country: Poland
facility: Local Institution - 0019
city: Warszawa
country: Poland
facility: Local Institution - 0022
city: Wroclaw
country: Poland
facility: Local Institution - 0010
city: Wroclaw
country: Poland
facility: Local Institution - 0023
city: Brasov
country: Romania
facility: Local Institution - 0033
city: Galati
country: Romania
facility: Local Institution - 0004
city: Ramnicu Valcea
country: Romania
facility: Local Institution - 0002
city: Ekaterinburg
country: Russian Federation
facility: Local Institution - 0061
city: Kemerovo
country: Russian Federation
facility: Local Institution - 0056
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 0072
city: Orenburg
country: Russian Federation
facility: Local Institution - 0057
city: Saint - Petersburg
country: Russian Federation
facility: Local Institution - 0062
city: Smolensk
country: Russian Federation
facility: Local Institution - 0070
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0058
city: Vladimir
country: Russian Federation
facility: Local Institution - 0055
city: Yaroslavl
country: Russian Federation
facility: Local Institution - 0068
city: Yaroslavl
country: Russian Federation
facility: Local Institution - 0060
city: Malaga
country: Spain
facility: Local Institution - 0126
city: Sabadell
country: Spain
facility: Local Institution - 0138
city: Sevilla
country: Spain
facility: Local Institution - 0124
city: Taichung
country: Taiwan
facility: Local Institution - 0052
city: Taipei City
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution - 0051
city: Taipei
country: Taiwan
facility: Local Institution - 0137
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: