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Trial details imported from ClinicalTrials.gov

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




Registration number
Help: Registration number
NCT03920267
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
27/03/2019
Date registered
Help: Date registered
18/04/2019
Date last updated
Help: Date last updated
20/03/2026

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
Additional trial identifiers [1] 0 0
2018-003471-35
Additional trial identifiers [2] 0 0
IM011-074
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(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 the intervention or 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
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
Timepoint [1] 0 0
From Day 1 until 30 days after last dose (up to approximately 42 months)
Primary outcome [2] 0 0
Number of Participants With Abnormalities in Vital Signs
Timepoint [2] 0 0
From Day 1 until 30 days after last dose (up to approximately 42 months)
Primary outcome [3] 0 0
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
Timepoint [3] 0 0
From Day 1 until 30 days after last dose (up to approximately 42 months)

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
Healthy volunteers
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
Completed
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
Actual
21/03/2025
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
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Alabama
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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Georgia
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Santa Fe Province
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Argentina
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Tucumán Province
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Argentina
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CABA
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Argentina
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Córdoba
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Argentina
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Mendoza
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Brazil
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Estado de Bahia
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Brazil
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Goiás
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Brazil
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Minas Gerais
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Brazil
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Paraná
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Brazil
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Rio Grande do Sul
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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Ontario
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Chía
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Colombia
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Zipaquirá
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Szeged
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Miyagi
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Japan
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Tochigi
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Japan
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Tokyo
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Mexico City
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Mexico
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Nuevo León
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Mexico
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San Luis Potosí City
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Poland
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Bydgoszcz
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Poland
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Koscian
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Poland
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Krakow
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Lublin
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Poznan
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Sosnowiec
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Warsaw
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Poland
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Wroclaw
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Romania
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Brasov
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Romania
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Galati
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Romania
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Râmnicu Vâlcea
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Russia
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Kemerovo
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Russia
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Novosibirsk
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Russia
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Orenburg
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Russia
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Saint Petersburg
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Russia
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Smolensk
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Russia
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Vladimir
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Russia
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Yaroslavl
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Russia
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Yekaterinburg
Country [64] 0 0
South Korea
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Seoul
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South Korea
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Suwon
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Spain
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Málaga
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Spain
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Sabadell
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Spain
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Seville
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taichung
Country [70] 0 0
Taiwan
State/province [70] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03920267