Clinical trial NCT04186871: 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
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autoimmune Disorder
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Primary Sjögren's Syndrome
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 119
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: The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).


Eligibility criteria: Inclusion Criteria:

Sub-study for Systemic Lupus Erythematosus (SLE)

* 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:

Sub-study for SLE

* 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

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE
timeFrame: Week 24
measure: The Percent of Participants With Composite Response at Week 24 - pSS
timeFrame: Week 24
measure: Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in SLEDAI-2K Score at Week 24 - SLE
timeFrame: Week 24
measure: Percent of Participants With BICLA Response at Week 24 - SLE
timeFrame: Week 24
measure: Change From Baseline in DAS28-CRP at Week 12 - RA
timeFrame: Week 12
measure: Change From Baseline in DAS28-ESR at Week 12 - RA
timeFrame: Week 12
measure: Change From Baseline in SDAI at Week 12- RA
timeFrame: Week 12
measure: Change From Baseline in CDAI at Week 12 - RA
timeFrame: Week 12
measure: Percent of Participants With ACR20 Response Compared to Baseline at Week 12 - RA
timeFrame: Week 12
measure: Percent of Participants With ACR70 Response Compared to Baseline at Week 12 - RA
timeFrame: Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0019
state: Arizona
city: Covina
country: United States
facility: Local Institution - 0002
state: California
city: Encino
country: United States
facility: Local Institution - 0024
state: California
city: San Diego
country: United States
facility: Local Institution - 0034
state: California
city: Upland
country: United States
facility: Local Institution - 0032
state: California
city: Brandon
country: United States
facility: Local Institution
state: Florida
city: DeBary
country: United States
facility: Local Institution - 0062
state: Florida
city: Hialeah
country: United States
facility: Local Institution - 0035
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Plantation
country: United States
facility: Local Institution - 0029
state: Florida
city: Lawrenceville
country: United States
facility: Local Institution - 0009
state: Georgia
city: Skokie
country: United States
facility: Local Institution - 0014
state: Illinois
city: Evansville
country: United States
facility: Local Institution
state: Indiana
city: Monroe
country: United States
facility: Local Institution - 0005
state: Louisiana
city: Ann Arbor
country: United States
facility: Local Institution - 0041
state: Michigan
city: Grand Blanc
country: United States
facility: Local Institution - 0082
state: Michigan
city: Saint Louis
country: United States
facility: Local Institution - 0096
state: Missouri
city: Saint Louis
country: United States
facility: Local Institution - 0040
state: Missouri
city: Lincoln
country: United States
facility: Local Institution - 0056
state: Nebraska
city: Las Vegas
country: United States
facility: Local Institution - 0007
state: Nevada
city: Manhasset
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0008
state: North Carolina
city: Salisbury
country: United States
facility: Local Institution - 0006
state: North Carolina
city: Minot
country: United States
facility: Local Institution
state: North Dakota
city: Oklahoma City
country: United States
facility: Local Institution - 0023
state: Oklahoma
city: Oklahoma City
country: United States
facility: Local Institution - 0022
state: Oklahoma
city: Duncansville
country: United States
facility: Local Institution - 0010
state: Pennsylvania
city: Orangeburg
country: United States
facility: Local Institution - 0045
state: South Carolina
city: Summerville
country: United States
facility: Local Institution - 0021
state: South Carolina
city: Jackson
country: United States
facility: Local Institution - 0079
state: Tennessee
city: Memphis
country: United States
facility: Local Institution - 0001
state: Tennessee
city: Colleyville
country: United States
facility: Local Institution - 0092
state: Texas
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution - 0063
state: Texas
city: Mesquite
country: United States
facility: Local Institution - 0016
state: Texas
city: Plano
country: United States
facility: Local Institution - 0030
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0031
state: Texas
city: Waco
country: United States
facility: Local Institution
state: Texas
city: Spokane
country: United States
facility: Local Institution - 0083
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0065
state: Buenos Aires
city: San Miguel De Tucum
country: Argentina
facility: Local Institution - 0047
state: Tucuman
city: San Juan
country: Argentina
facility: Local Institution - 0066
city: Gent
country: Belgium
facility: Local Institution - 0064
city: Leuven
country: Belgium
facility: Local Institution - 0069
city: Brest
country: France
facility: Local Institution - 0075
city: Marseille
country: France
facility: Local Institution - 0070
city: Montpellier Cedex 5
country: France
facility: Local Institution - 0067
city: Berlin
country: Germany
facility: Local Institution - 0038
city: Freiburg
country: Germany
facility: Local Institution - 0049
city: Herne
country: Germany
facility: Local Institution - 0074
city: Koln
country: Germany
facility: Local Institution - 0037
city: Munchen
country: Germany
facility: Local Institution - 0051
city: Guadalajara
country: Mexico
facility: Local Institution - 0060
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution - 0042
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution - 0113
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution - 0102
state: Morelos
city: Merida
country: Mexico
facility: Local Institution - 0104
state: Yucatan
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0114
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0050
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0059
city: Groningen
country: Netherlands
facility: Local Institution - 0004
city: Bialystok
country: Poland
facility: Local Institution - 0094
city: Bydgoszcz
country: Poland
facility: Local Institution - 0089
city: Bydgoszcz
country: Poland
facility: Local Institution - 0072
city: Elblag
country: Poland
facility: Local Institution - 0012
city: Elblag
country: Poland
facility: Local Institution - 0073
city: Poznan
country: Poland
facility: Local Institution - 0011
city: Torun
country: Poland
facility: Local Institution - 0091
city: Warszawa
country: Poland
facility: Local Institution - 0017
city: Warszawa
country: Poland
facility: Local Institution - 0033
city: Warszawa
country: Poland
facility: Local Institution - 0101
city: Warszawa
country: Poland
facility: Local Institution - 0026
city: A Coru
country: Spain
facility: Local Institution - 0028
city: Barcelona
country: Spain
facility: Local Institution - 0036
city: Malaga
country: Spain
facility: Local Institution - 0025
city: Sevilla
country: Spain
facility: Local Institution - 0018
city: Valencia
country: Spain
facility: Local Institution - 0061
city: Leeds
country: United Kingdom
facility: Local Institution - 0076
city: London
country: United Kingdom
facility: Local Institution - 0058
city: Southampton
country: United Kingdom
facility: Local Institution - 0052
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: