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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/NCT03920267




Registration number
NCT03920267
Ethics application status
Date submitted
27/03/2019
Date registered
18/04/2019
Date last updated
28/09/2023

Titles & IDs
Public title
Long-Term Safety and Efficacy Study of Deucravacitinib 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
Specified dose on specified days
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 178 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 178 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 178 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 178 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 178 weeks)

Eligibility
Key inclusion criteria
- Completion of SLE Study (NCT03252587) through the protocol-required treatment period,
and currently receiving blinded study drug. Note: If a subject is not receiving
blinded study drug due to exceptional circumstances (eg, missed investigational
product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may
be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
Minimum age
18 Years
Maximum age
75 Years
Sex
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 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
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
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
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
Caba
Country [17] 0 0
Argentina
State/province [17] 0 0
Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Mendoza
Country [19] 0 0
Brazil
State/province [19] 0 0
Bahia
Country [20] 0 0
Brazil
State/province [20] 0 0
Goias
Country [21] 0 0
Brazil
State/province [21] 0 0
Minas Gerais
Country [22] 0 0
Brazil
State/province [22] 0 0
Parana
Country [23] 0 0
Brazil
State/province [23] 0 0
RIO Grande DO SUL
Country [24] 0 0
Brazil
State/province [24] 0 0
SAO Paulo
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
Country [30] 0 0
Colombia
State/province [30] 0 0
Chia
Country [31] 0 0
Colombia
State/province [31] 0 0
Zipaquira
Country [32] 0 0
Hungary
State/province [32] 0 0
Debrecen
Country [33] 0 0
Hungary
State/province [33] 0 0
Gyula
Country [34] 0 0
Hungary
State/province [34] 0 0
Szeged
Country [35] 0 0
Japan
State/province [35] 0 0
Chiba
Country [36] 0 0
Japan
State/province [36] 0 0
Fukuoka
Country [37] 0 0
Japan
State/province [37] 0 0
Hokkaido
Country [38] 0 0
Japan
State/province [38] 0 0
Miyagi
Country [39] 0 0
Japan
State/province [39] 0 0
Tochigi
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Suwon
Country [43] 0 0
Mexico
State/province [43] 0 0
Distrito Federal
Country [44] 0 0
Mexico
State/province [44] 0 0
Guanajuato
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco
Country [46] 0 0
Mexico
State/province [46] 0 0
Nuevo LEON
Country [47] 0 0
Mexico
State/province [47] 0 0
San Luis Potosi
Country [48] 0 0
Poland
State/province [48] 0 0
Bydgoszcz
Country [49] 0 0
Poland
State/province [49] 0 0
Koscian
Country [50] 0 0
Poland
State/province [50] 0 0
Krakow
Country [51] 0 0
Poland
State/province [51] 0 0
Krak
Country [52] 0 0
Poland
State/province [52] 0 0
Lublin
Country [53] 0 0
Poland
State/province [53] 0 0
Poznan
Country [54] 0 0
Poland
State/province [54] 0 0
Sosnowiec
Country [55] 0 0
Poland
State/province [55] 0 0
Warsaw
Country [56] 0 0
Poland
State/province [56] 0 0
Warszawa
Country [57] 0 0
Poland
State/province [57] 0 0
Wroclaw
Country [58] 0 0
Romania
State/province [58] 0 0
Brasov
Country [59] 0 0
Romania
State/province [59] 0 0
Galati
Country [60] 0 0
Romania
State/province [60] 0 0
Ramnicu Valcea
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Ekaterinburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Kemerovo
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Novosibirsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Orenburg
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Saint - Petersburg
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Smolensk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
St. Petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Vladimir
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Yaroslavl
Country [70] 0 0
Spain
State/province [70] 0 0
Malaga
Country [71] 0 0
Spain
State/province [71] 0 0
Sabadell
Country [72] 0 0
Spain
State/province [72] 0 0
Sevilla
Country [73] 0 0
Taiwan
State/province [73] 0 0
Taichung
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taipei City
Country [75] 0 0
Taiwan
State/province [75] 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/ct2/show/NCT03920267
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03920267