Clinical trial NCT03252587: An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

* Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
* Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
* One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
* Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash \[score must be confirmed by Central Review Services (CRS)\]
* Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
* SLE overlap syndromes such as scleroderma and mixed connective tissue disease
* Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)
* History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
timeFrame: At week 32
Secondary outcomes:
measure: Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
timeFrame: At week 48
measure: Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
timeFrame: At week 48
measure: Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
timeFrame: At Week 48
measure: Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10
timeFrame: At week 48
measure: Change From Baseline in the 40-Joint Count
timeFrame: Baseline and week 48
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose to 30 days post last dose (Up to 52 weeks)
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 30 days post last dose (Up to 52 weeks)
measure: Number of Participants With Abnormalities in Vital Signs
timeFrame: From first dose to 30 days post last dose (Up to 52 weeks)
measure: Number of Participants With Abnormalities in Electrocardiograms (ECGs)
timeFrame: From baseline to up to week 48
measure: BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
measure: BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
measure: BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
timeFrame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
measure: Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
timeFrame: From baseline to week 44
measure: Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
timeFrame: From baseline to week 32
measure: Percent Change From Baseline in Complement Proteins C3 and C4 Levels
timeFrame: From baseline to week 52
measure: Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
timeFrame: From baseline to week 32
measure: Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
timeFrame: From baseline to week 52
measure: Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
timeFrame: From baseline to week 32
measure: Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
timeFrame: At week 32
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0178
state: Alabama
city: Little Rock
country: United States
facility: Little Rock Diagnostic Clinic
state: Arkansas
city: El Cajon
country: United States
facility: Local Institution - 0023
state: California
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles County Hospital and University of Southern California Medical Center
state: California
city: Orange
country: United States
facility: University of California at Irvine College of Medicine
state: California
city: Palm Desert
country: United States
facility: Local Institution - 0227
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials - Thousand Oaks
state: California
city: Torrance
country: United States
facility: The Lundquist Institute at Harbor-UCLA Medical Center
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials
state: California
city: Farmington
country: United States
facility: Local Institution - 0034
state: Connecticut
city: New Haven
country: United States
facility: Local Institution - 0195
state: Connecticut
city: Aventura
country: United States
facility: Local Institution - 0010
state: Florida
city: Brandon
country: United States
facility: Local Institution - 0066
state: Florida
city: Gainesville
country: United States
facility: Local Institution - 0214
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0233
state: Florida
city: Ormond Beach
country: United States
facility: Local Institution - 0057
state: Florida
city: Tamarac
country: United States
facility: Local Institution - 0002
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0038
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0206
state: Georgia
city: Decatur
country: United States
facility: Local Institution - 0022
state: Georgia
city: Lawrenceville
country: United States
facility: Local Institution - 0083
state: Georgia
city: Stockbridge
country: United States
facility: Arthritis Research and Treatment Center
state: Georgia
city: Cumberland
country: United States
facility: Klein & Associates
state: Maryland
city: Hagerstown
country: United States
facility: Klein and Associates
state: Maryland
city: Lansing
country: United States
facility: Advanced Rheumatology - Lansing
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Brooklyn
country: United States
facility: Local Institution - 0011
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Health Science University
state: New York
city: Lake Success
country: United States
facility: Local Institution - 0082
state: New York
city: New York
country: United States
facility: Local Institution - 0109
state: New York
city: New York
country: United States
facility: Local Institution - 0232
state: New York
city: Chapel Hill
country: United States
facility: Local Institution - 0119
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 0026
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution - 0180
state: Oklahoma
city: Oklahoma City
country: United States
facility: Local Institution - 0197
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Local Institution - 0174
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0190
state: South Carolina
city: Jackson
country: United States
facility: Local Institution - 0001
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0087
state: Texas
city: Austin
country: United States
facility: Local Institution - 0086
state: Texas
city: Cypress
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0193
state: Texas
city: Houston
country: United States
facility: Local Institution - 0204
state: Texas
city: Houston
country: United States
facility: Local Institution - 0061
state: Texas
city: Mesquite
country: United States
facility: Local Institution - 0047
state: Texas
city: San Antonio
country: United States
facility: Arthritis and Osteoporosis Center of South Texas
state: Texas
city: Chesapeake
country: United States
facility: Local Institution - 0171
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Caba
country: Argentina
facility: Local Institution - 0166
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0139
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0185
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0136
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0138
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution - 0152
state: Santa Fe
city: San Miguel De Tucum
country: Argentina
facility: Local Institution - 0097
state: Tucuman
city: Cordoba
country: Argentina
facility: Local Institution - 0096
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Mendoza
country: Argentina
facility: Local Institution - 0137
city: Maroochydore
country: Australia
facility: Local Institution - 0241
state: Queensland
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital
state: Victoria
city: Salvador
country: Brazil
facility: Local Institution - 0130
state: Bahia
city: Goiania
country: Brazil
facility: Local Institution - 0129
state: Goias
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: Local Institution - 0125
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0126
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution - 0128
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: SAO Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Local Institution - 0151
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: CITIPA - Centro de Imunoterapia de Ipanema
city: Sao Paulo
country: Brazil
facility: Local Institution - 0148
city: Calgary
country: Canada
facility: Local Institution - 0247
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0245
state: Ontario
city: Barranquilla
country: Colombia
facility: Local Institution - 0098
city: Barranquilla
country: Colombia
facility: Local Institution - 0099
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
city: Bucaramanga
country: Colombia
facility: Medicity SAS
city: Cali
country: Colombia
facility: Local Institution - 0161
city: Chia
country: Colombia
facility: Local Institution - 0100
city: Zipaquira
country: Colombia
facility: Local Institution - 0159
city: Berlin
country: Germany
facility: Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi
city: Hannover
country: Germany
facility: Klinik fur Nieren- und Hochdruckerkrankungen
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Local Institution - 0035
city: Szeged
country: Hungary
facility: Local Institution - 0123
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Kfar Saba
country: Israel
facility: Local Institution
city: Petah Tikva
country: Israel
facility: Local Institution
city: Tel-Hashomer
country: Israel
facility: Local Institution
city: Chiba-shi
country: Japan
facility: Local Institution - 0117
state: Chiba
city: Kamogawa-shi
country: Japan
facility: Kameda Clinic
state: Chiba
city: Kitakyushu
country: Japan
facility: Local Institution - 0177
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Local Institution - 0141
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sendai City
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Tomigusuku-shi
country: Japan
facility: Tomishiro Central Hospital
state: Okinawa
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University
state: Tochigi
city: Shimotsuke-city
country: Japan
facility: Local Institution - 0183
state: Tochigi
city: Chuo-ku
country: Japan
facility: Local Institution - 0154
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Local Institution - 0144
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Tokyo
country: Japan
facility: Local Institution - 0162
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Tokyo
country: Japan
facility: National Hospital Organization Tokyo Medical Center
city: Tokyo
country: Japan
facility: Local Institution - 0133
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Gwangju
country: Korea, Republic of
facility: Local Institution - 0253
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0054
city: Suwon
country: Korea, Republic of
facility: Local Institution - 0050
city: Mexico City
country: Mexico
facility: Local Institution - 0140
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0173
state: Distrito Federal
city: Leon, Guanajuato
country: Mexico
facility: Local Institution - 0163
state: Guanajuato
city: Leon
country: Mexico
facility: Local Institution - 0172
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution - 0135
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution - 0156
state: Jalisco
city: Zapopan
country: Mexico
facility: Juan Alberto Rodriguez Ruiz
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0134
state: Nuevo LEON
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0149
city: Veracruz
country: Mexico
facility: Faicic S. de R.L. de C.V.
city: Bydgoszcz
country: Poland
facility: Local Institution - 0089
city: Bytom
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia w Gdyni
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o.
city: Konskie
country: Poland
facility: Zespol Opieki Zdrowotnej w Konskich
city: Koscian
country: Poland
facility: Local Institution - 0182
city: Krakow
country: Poland
facility: Local Institution - 0211
city: Krakow
country: Poland
facility: Local Institution - 0222
city: Krak
country: Poland
facility: Centrum Medyczne ProMiMed
city: Lublin
country: Poland
facility: REUMED Sp. z o.o.
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmanska - Poznan
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Poznan
country: Poland
facility: Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia
city: Sosnowiec
country: Poland
facility: Local Institution - 0093
city: Stalowa Wola
country: Poland
facility: SANUS Szpital Specjalistyczny
city: Warszawa
country: Poland
facility: Local Institution - 0219
city: Warszawa
country: Poland
facility: Local Institution - 0192
city: Warszawa
country: Poland
facility: Local Institution - 0090
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa Targowek
city: Wroclaw
country: Poland
facility: Local Institution - 0077
city: Wroclaw
country: Poland
facility: Local Institution - 0184
city: Wroclaw
country: Poland
facility: Local Institution - 0025
city: Brasov
country: Romania
facility: Neomed Research
city: Bucuresti
country: Romania
facility: Centrul Medical Sana
city: Bucuresti
country: Romania
facility: Spitalul Sfanta Maria
city: Bucuresti
country: Romania
facility: Spitalul Clinic Dr. Ioan Cantacuzino
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca
city: Galati
country: Romania
facility: Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei
city: Ramnicu Valcea
country: Romania
facility: Spitalul Judetean de Urgenta Valcea
city: Ekaterinburg
country: Russian Federation
facility: CjSC
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical University
city: Kemerovo
country: Russian Federation
facility: Medical Center Maksimum Zdorovia
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 0210
city: Orenburg
country: Russian Federation
facility: Local Institution - 0006
city: Petrozavodsk
country: Russian Federation
facility: State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
city: Saint - Petersburg
country: Russian Federation
facility: Local Institution - 0207
city: Saint Petersburg
country: Russian Federation
facility: Clinical Rheumatological Hospital Number 25
city: Saint Petersburg
country: Russian Federation
facility: Polyclinic of Private Security Personnel
city: Smolensk
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0223
city: Tolyatti
country: Russian Federation
facility: Tolyatti city clinical hospital ߵ
city: Vladimir
country: Russian Federation
facility: Biomed
city: Yaroslavl
country: Russian Federation
facility: Local Institution - 0208
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2
city: A Coru
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital Universitari Vall dHebron
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga Hospital General
city: Merida
country: Spain
facility: Hospital de Merida
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Sevilla
country: Spain
facility: Local Institution - 0228
city: Changhua City
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution - 0114
city: Taipei City
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution - 0088
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.