Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
NCT ID: NCT04186871
Last Updated: 2024-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
119 participants
INTERVENTIONAL
2020-01-07
2022-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Systemic Lupus Erythematosus (SLE): branebrutinib
branebrutinib
Specified dose on specified days
SLE: placebo
branebrutinib placebo
Specified dose on specified days
Primary Sjögren's Syndrome (pSS): branebrutinib
branebrutinib
Specified dose on specified days
pSS: placebo
branebrutinib placebo
Specified dose on specified days
Rheumatoid Arthritis (RA): branebrutinib followed by abatacept
branebrutinib
Specified dose on specified days
abatacept
Specified dose on specified days
RA: placebo followed by abatacept
abatacept
Specified dose on specified days
branebrutinib placebo
Specified dose on specified days
Interventions
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branebrutinib
Specified dose on specified days
abatacept
Specified dose on specified days
branebrutinib placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
* Diagnosed with SLE more than 24 weeks before screening visit
Sub-study for primary Sjögren's Syndrome (pSS)
* Moderate to severe pSS, meeting ACR-EULAR classification criteria
Sub-study for active Rheumatoid Arthritis (RA)
* Moderate to severe adult-onset RA
* ACR global functional status class I to III
Women and men must agree to follow instructions for methods of contraception.
Exclusion Criteria
* Certain other autoimmune diseases and overlap syndromes
Sub-study for pSS
* Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions
Sub-study for RA
* Diagnosis with juvenile arthritis or idiopathic arthritis before age 16
For all sub-studies:
* History of any significant drug allergy
* Active infection, significant concurrent medical condition, or clinically significant abnormalities
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0019
Phoenix, Arizona, United States
Local Institution - 0002
Covina, California, United States
Local Institution - 0024
Encino, California, United States
Local Institution - 0034
San Diego, California, United States
Local Institution - 0032
Upland, California, United States
Local Institution
Brandon, Florida, United States
Local Institution - 0062
DeBary, Florida, United States
Local Institution - 0035
Hialeah, Florida, United States
Local Institution
Jacksonville, Florida, United States
Local Institution - 0029
Plantation, Florida, United States
Local Institution - 0009
Lawrenceville, Georgia, United States
Local Institution - 0014
Skokie, Illinois, United States
Local Institution
Evansville, Indiana, United States
Local Institution - 0005
Monroe, Louisiana, United States
Local Institution - 0041
Ann Arbor, Michigan, United States
Local Institution - 0082
Grand Blanc, Michigan, United States
Local Institution - 0096
St Louis, Missouri, United States
Local Institution - 0040
St Louis, Missouri, United States
Local Institution - 0056
Lincoln, Nebraska, United States
Local Institution - 0007
Las Vegas, Nevada, United States
Local Institution
Manhasset, New York, United States
Local Institution
New York, New York, United States
Local Institution - 0008
Charlotte, North Carolina, United States
Local Institution - 0006
Salisbury, North Carolina, United States
Local Institution
Minot, North Dakota, United States
Local Institution - 0023
Oklahoma City, Oklahoma, United States
Local Institution - 0022
Oklahoma City, Oklahoma, United States
Local Institution - 0010
Duncansville, Pennsylvania, United States
Local Institution - 0045
Orangeburg, South Carolina, United States
Local Institution - 0021
Summerville, South Carolina, United States
Local Institution - 0079
Jackson, Tennessee, United States
Local Institution - 0001
Memphis, Tennessee, United States
Local Institution - 0092
Colleyville, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution - 0063
Houston, Texas, United States
Local Institution - 0016
Mesquite, Texas, United States
Local Institution - 0030
Plano, Texas, United States
Local Institution - 0031
San Antonio, Texas, United States
Local Institution
Waco, Texas, United States
Local Institution - 0083
Spokane, Washington, United States
Local Institution - 0065
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0047
San Miguel de Tucum, Tucumán Province, Argentina
Local Institution - 0066
San Juan, , Argentina
Local Institution - 0064
Ghent, , Belgium
Local Institution - 0069
Leuven, , Belgium
Local Institution - 0075
Brest, , France
Local Institution - 0070
Marseille, , France
Local Institution - 0067
Montpellier, , France
Local Institution - 0038
Berlin, , Germany
Local Institution - 0037
Cologne, , Germany
Local Institution - 0049
Freiburg im Breisgau, , Germany
Local Institution - 0074
Herne, , Germany
Local Institution - 0051
München, , Germany
Local Institution - 0060
Guadalajara, Jalisco, Mexico
Local Institution - 0042
Guadalajara, Jalisco, Mexico
Local Institution - 0113
Zapopan, Jalisco, Mexico
Local Institution - 0102
Cuernavaca, Morelos, Mexico
Local Institution - 0104
Mérida, Yucatán, Mexico
Local Institution - 0114
San Luis Potosí City, , Mexico
Local Institution - 0050
San Luis Potosí City, , Mexico
Local Institution - 0059
San Luis Potosí City, , Mexico
Local Institution - 0004
Groningen, , Netherlands
Local Institution - 0094
Bialystok, , Poland
Local Institution - 0089
Bydgoszcz, , Poland
Local Institution - 0072
Bydgoszcz, , Poland
Local Institution - 0012
Elblag, , Poland
Local Institution - 0073
Elblag, , Poland
Local Institution - 0011
Poznan, , Poland
Local Institution - 0091
Torun, , Poland
Local Institution - 0017
Warsaw, , Poland
Local Institution - 0033
Warsaw, , Poland
Local Institution - 0101
Warsaw, , Poland
Local Institution - 0026
Warsaw, , Poland
Local Institution - 0028
A Coru, , Spain
Local Institution - 0036
Barcelona, , Spain
Local Institution - 0025
Málaga, , Spain
Local Institution - 0018
Seville, , Spain
Local Institution - 0061
Valencia, , Spain
Local Institution - 0076
Leeds, , United Kingdom
Local Institution - 0058
London, , United Kingdom
Local Institution - 0052
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-002205-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM014-029
Identifier Type: -
Identifier Source: org_study_id
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