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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03920267




Registration number
NCT03920267
Ethics application status
Date submitted
27/03/2019
Date registered
18/04/2019
Date last updated
8/10/2020

Titles & IDs
Public title
Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus
Scientific title
A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2018-003471-35
Secondary ID [2] 0 0
IM011-074
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165

Experimental: BMS-986165 Dose 1 -

Experimental: BMS-986165 Dose 2 -

Experimental: BMS-986165 Dose 3 -


Treatment: Drugs: BMS-986165
Administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Up to 30 days after last treatment dose (approximately 108 weeks)
Primary outcome [2] 0 0
Number of participants with Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 30 days after last treatment dose (approximately 108 weeks)
Primary outcome [3] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [3] 0 0
Up to 30 days after last treatment dose (approximately 108 weeks)
Primary outcome [4] 0 0
Number of participants with abnormal change from baseline in laboratory measurements over time
Timepoint [4] 0 0
Up to 30 days after last treatment dose (approximately 108 weeks)
Primary outcome [5] 0 0
Number of participants with abnormal change from baseline in vital signs over time
Timepoint [5] 0 0
Up to 30 days after last treatment dose (approximately 108 weeks)

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- Completion of SLE Study (NCT03252587) through the protocol-required treatment period,
and currently receiving blinded study drug

- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test and
must agree to use correctly a highly effective method(s) of contraception for the
duration of treatment with study drug
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Local Institution - Maroochydore
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
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United States of America
State/province [8] 0 0
Oklahoma
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United States of America
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Pennsylvania
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United States of America
State/province [10] 0 0
South Carolina
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United States of America
State/province [11] 0 0
Tennessee
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United States of America
State/province [12] 0 0
Texas
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Argentina
State/province [13] 0 0
Buenos Aires
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Argentina
State/province [14] 0 0
Santa FE
Country [15] 0 0
Argentina
State/province [15] 0 0
Tucuman
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Argentina
State/province [17] 0 0
Mendoza
Country [18] 0 0
Brazil
State/province [18] 0 0
Bahia
Country [19] 0 0
Brazil
State/province [19] 0 0
Goias
Country [20] 0 0
Brazil
State/province [20] 0 0
Minas Gerais
Country [21] 0 0
Brazil
State/province [21] 0 0
Parana
Country [22] 0 0
Brazil
State/province [22] 0 0
RIO Grande DO SUL
Country [23] 0 0
Brazil
State/province [23] 0 0
SAO Paulo
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio de Janeiro
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Colombia
State/province [28] 0 0
Barranquilla
Country [29] 0 0
Colombia
State/province [29] 0 0
Bogot
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Colombia
State/province [30] 0 0
Bucaramanga
Country [31] 0 0
Colombia
State/province [31] 0 0
Chia
Country [32] 0 0
Colombia
State/province [32] 0 0
Zipaquira
Country [33] 0 0
Germany
State/province [33] 0 0
Hannover
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Debrecen
Country [36] 0 0
Hungary
State/province [36] 0 0
Gyula
Country [37] 0 0
Hungary
State/province [37] 0 0
Szeged
Country [38] 0 0
Israel
State/province [38] 0 0
Ramat-Gan
Country [39] 0 0
Japan
State/province [39] 0 0
Chiba
Country [40] 0 0
Japan
State/province [40] 0 0
Fukuoka
Country [41] 0 0
Japan
State/province [41] 0 0
Hokkaido
Country [42] 0 0
Japan
State/province [42] 0 0
Ishikawa
Country [43] 0 0
Japan
State/province [43] 0 0
Miyagi
Country [44] 0 0
Japan
State/province [44] 0 0
Tochigi
Country [45] 0 0
Japan
State/province [45] 0 0
Tokyo
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Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Suwon
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Nuevo LEON
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Mexico
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San Luis Potosi
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Mexico
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Veracruz
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Poland
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Bydgoszcz
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Poland
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Bytom
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Elbl?g
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Gdynia
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Ko?cian
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Ko?skie
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Krakow
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Krak
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Poland
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Lublin
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Poland
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Pozna?
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Poland
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Poznan
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Poland
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Sosnowiec
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Poland
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Stalowa Wola
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Poland
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Warszawa
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Poland
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Wroc?aw
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Poland
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Wroclaw
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Romania
State/province [70] 0 0
Brasov
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Romania
State/province [71] 0 0
Bucuresti
Country [72] 0 0
Romania
State/province [72] 0 0
Cluj-Napoca
Country [73] 0 0
Romania
State/province [73] 0 0
Galati
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Romania
State/province [74] 0 0
R?cu V?a
Country [75] 0 0
Russian Federation
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Ekaterinburg
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Russian Federation
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Kemerovo
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Russian Federation
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Novosibirsk
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Russian Federation
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Orenburg
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Russian Federation
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Petrozavodsk
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Russian Federation
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Saint - Petersburg
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Russian Federation
State/province [81] 0 0
Saint Petersburg
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Saint-Petersburg
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Smolensk
Country [84] 0 0
Russian Federation
State/province [84] 0 0
St. Petersburg
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Russian Federation
State/province [85] 0 0
Tolyatti
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Vladimir
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Yaroslavl
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Yatoslavl
Country [89] 0 0
Spain
State/province [89] 0 0
A Coru
Country [90] 0 0
Spain
State/province [90] 0 0
Malaga
Country [91] 0 0
Spain
State/province [91] 0 0
Sabadell
Country [92] 0 0
Spain
State/province [92] 0 0
Sevilla
Country [93] 0 0
Taiwan
State/province [93] 0 0
Taichung
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT03920267
Trial related presentations / publications
Public notes

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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03920267