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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04186871




Registration number
NCT04186871
Ethics application status
Date submitted
28/11/2019
Date registered
5/12/2019
Date last updated
19/12/2022

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2019-002205-22
Secondary ID [2] 0 0
IM014-029
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Disorder 0 0
Rheumatoid Arthritis 0 0
Systemic Lupus Erythematosus 0 0
Primary Sjögren's Syndrome 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - branebrutinib
Treatment: Drugs - abatacept
Treatment: Drugs - branebrutinib placebo

Experimental: Systemic Lupus Erythematosus (SLE): branebrutinib -

Placebo Comparator: SLE: placebo -

Experimental: Primary Sjögren's Syndrome (pSS): branebrutinib -

Placebo Comparator: pSS: placebo -

Experimental: Rheumatoid Arthritis (RA): branebrutinib followed by abatacept -

Placebo Comparator: RA: placebo followed by abatacept -


Treatment: Drugs: branebrutinib
Specified dose on specified days

Treatment: Drugs: abatacept
Specified dose on specified days

Treatment: Drugs: branebrutinib placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Systemic lupus erythematosus (SLE): Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) activity score response
Timepoint [1] 0 0
at 24 weeks
Primary outcome [2] 0 0
pSS: Proportion of participants with changes in a composite score that includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular staining, salivary flow and serological marker
Timepoint [2] 0 0
at 24 weeks
Primary outcome [3] 0 0
Rheumatoid arthritis (RA): ACR50 response
Timepoint [3] 0 0
at 12 weeks
Secondary outcome [1] 0 0
SLE: SLEDAI-2K score response
Timepoint [1] 0 0
at 24 weeks
Secondary outcome [2] 0 0
SLE: BILAG-based Composite Lupus Assessment response
Timepoint [2] 0 0
at 24 weeks
Secondary outcome [3] 0 0
RA: DAS28-CRP response
Timepoint [3] 0 0
at 12 weeks
Secondary outcome [4] 0 0
RA: DAS28-ESR response
Timepoint [4] 0 0
at 12 weeks
Secondary outcome [5] 0 0
RA: SDAI response
Timepoint [5] 0 0
at 12 weeks
Secondary outcome [6] 0 0
RA: CDAI response
Timepoint [6] 0 0
at 12 weeks
Secondary outcome [7] 0 0
RA: ACR20 response
Timepoint [7] 0 0
at 12 weeks
Secondary outcome [8] 0 0
RA: ACR70 response
Timepoint [8] 0 0
at 12 weeks
Secondary outcome [9] 0 0
Number of participants with adverse events (AEs)
Timepoint [9] 0 0
Up to 32 weeks
Secondary outcome [10] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [10] 0 0
Up to 32 weeks
Secondary outcome [11] 0 0
Number of participants with vital sign abnormalities
Timepoint [11] 0 0
Up to 32 weeks
Secondary outcome [12] 0 0
Number of participants with electrocardiogram (ECG) abnormalities
Timepoint [12] 0 0
Up to 32 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/12/2022
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
North Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Tucuman
Country [23] 0 0
Argentina
State/province [23] 0 0
San Juan
Country [24] 0 0
Belgium
State/province [24] 0 0
Gent
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
France
State/province [26] 0 0
Brest
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
State/province [28] 0 0
Montpellier Cedex 5
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Freiburg
Country [31] 0 0
Germany
State/province [31] 0 0
Herne
Country [32] 0 0
Germany
State/province [32] 0 0
Koln
Country [33] 0 0
Germany
State/province [33] 0 0
Munchen
Country [34] 0 0
Mexico
State/province [34] 0 0
Jalisco
Country [35] 0 0
Mexico
State/province [35] 0 0
Morelos
Country [36] 0 0
Mexico
State/province [36] 0 0
Yucatan
Country [37] 0 0
Mexico
State/province [37] 0 0
San Luis Potosi
Country [38] 0 0
Netherlands
State/province [38] 0 0
Groningen
Country [39] 0 0
Poland
State/province [39] 0 0
Bialystok
Country [40] 0 0
Poland
State/province [40] 0 0
Bydgoszcz
Country [41] 0 0
Poland
State/province [41] 0 0
Elblag
Country [42] 0 0
Poland
State/province [42] 0 0
Poznan
Country [43] 0 0
Poland
State/province [43] 0 0
Torun
Country [44] 0 0
Poland
State/province [44] 0 0
Warszawa
Country [45] 0 0
Spain
State/province [45] 0 0
A Coru
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Malaga
Country [48] 0 0
Spain
State/province [48] 0 0
Sevilla
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Leeds
Country [51] 0 0
United Kingdom
State/province [51] 0 0
London
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04186871
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries