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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03252587




Registration number
NCT03252587
Ethics application status
Date submitted
15/08/2017
Date registered
17/08/2017
Date last updated
20/12/2022

Titles & IDs
Public title
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Scientific title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2017-001203-79
Secondary ID [2] 0 0
IM011-021
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
Other interventions - Placebo

Experimental: BMS-986165 Dose 1 oral administration -

Experimental: BMS-986165 Dose 2 oral administration -

Experimental: BMS-986165 Dose 3 oral administration -

Placebo comparator: Placebo oral administration -


Treatment: Drugs: BMS-986165
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
Timepoint [1] 0 0
At week 32
Secondary outcome [1] 0 0
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
Timepoint [1] 0 0
At week 48
Secondary outcome [2] 0 0
Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
Timepoint [2] 0 0
At week 48
Secondary outcome [3] 0 0
Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
Timepoint [3] 0 0
At Week 48
Secondary outcome [4] 0 0
Number of Participants With a =50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score =10
Timepoint [4] 0 0
At week 48
Secondary outcome [5] 0 0
Change From Baseline in the 40-Joint Count
Timepoint [5] 0 0
Baseline and week 48
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From first dose to 30 days post last dose (Up to 52 weeks)
Secondary outcome [7] 0 0
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Timepoint [7] 0 0
From first dose to 30 days post last dose (Up to 52 weeks)
Secondary outcome [8] 0 0
Number of Participants With Abnormalities in Vital Signs
Timepoint [8] 0 0
From first dose to 30 days post last dose (Up to 52 weeks)
Secondary outcome [9] 0 0
Number of Participants With Abnormalities in Electrocardiograms (ECGs)
Timepoint [9] 0 0
From baseline to up to week 48
Secondary outcome [10] 0 0
BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
Timepoint [10] 0 0
Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
Secondary outcome [11] 0 0
BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
Timepoint [11] 0 0
Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
Secondary outcome [12] 0 0
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
Timepoint [12] 0 0
Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
Secondary outcome [13] 0 0
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
Timepoint [13] 0 0
From baseline to week 44
Secondary outcome [14] 0 0
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
Timepoint [14] 0 0
From baseline to week 32
Secondary outcome [15] 0 0
Percent Change From Baseline in Complement Proteins C3 and C4 Levels
Timepoint [15] 0 0
From baseline to week 52
Secondary outcome [16] 0 0
Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
Timepoint [16] 0 0
From baseline to week 32
Secondary outcome [17] 0 0
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
Timepoint [17] 0 0
From baseline to week 52
Secondary outcome [18] 0 0
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
Timepoint [18] 0 0
From baseline to week 32
Secondary outcome [19] 0 0
Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
Timepoint [19] 0 0
At week 32

Eligibility
Key inclusion criteria
* Systemic lupus erythematosus (SLE) disease diagnosed = 24 weeks before the screening visit
* Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
* One of the following: elevated antinuclear antibodies (ANA) = 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
* Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score = 6 points and clinical SLEDAI-2K score = 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)]
* Men and women must agree to follow specific methods of contraception, if applicable
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
* SLE overlap syndromes such as scleroderma and mixed connective tissue disease
* Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)
* History of any significant drug allergy

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
21/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/10/2021
Sample size
Target
Accrual to date
Final
363
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0241 - Maroochydore
Recruitment hospital [2] 0 0
Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg West
Recruitment outside Australia
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United States of America
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Taipei
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Taiwan
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Taoyuan

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).
Trial website
https://clinicaltrials.gov/study/NCT03252587
Trial related presentations / publications
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03252587