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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/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
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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
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Secondary ID [1]
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0
2017-001203-79
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Secondary ID [2]
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IM011-021
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus
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0
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
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Assessment method [1]
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SRI(4) responder is defined as a patient whose disease course fulfills all of the following:
A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
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Timepoint [1]
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At week 32
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Secondary outcome [1]
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Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
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Assessment method [1]
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SRI(4) responder is defined as a patient whose disease course fulfills all of the following:
A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
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Timepoint [1]
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0
At week 48
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Secondary outcome [2]
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Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
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Assessment method [2]
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BICLA responder is defined as a patient whose disease course fulfills all of the following:
Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline
No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B
No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (= 0 points for change from baseline score)
No increase = 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity
No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment
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Timepoint [2]
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At week 48
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Secondary outcome [3]
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Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
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Assessment method [3]
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LLDAS is defined as follows:
SLEDAI-2K = 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System
No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters
Physician's Global Assessment of Disease Activity = 1 on a 3-point visual analog scale from no disease activity to severe disease activity
A current prednisolone (or equivalent) dose = 7.5 mg daily
Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
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Timepoint [3]
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At Week 48
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Secondary outcome [4]
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Number of Participants With a =50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score =10
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Assessment method [4]
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Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score = 10 at baseline who achieve a CLASI response, defined as a decrease of = 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia
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Timepoint [4]
0
0
At week 48
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Secondary outcome [5]
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Change From Baseline in the 40-Joint Count
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Assessment method [5]
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Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of:
Tender joint count (0 to 40)
Swollen joint count (0 to 40)
Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.
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Timepoint [5]
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Baseline and week 48
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Secondary outcome [6]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [6]
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Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment
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Timepoint [6]
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From first dose to 30 days post last dose (Up to 52 weeks)
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Secondary outcome [7]
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Number of Participants With Laboratory Abnormalities in Specific Liver Tests
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Assessment method [7]
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Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following:
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN)
Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)
No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic
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Timepoint [7]
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From first dose to 30 days post last dose (Up to 52 weeks)
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Secondary outcome [8]
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Number of Participants With Abnormalities in Vital Signs
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Assessment method [8]
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Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
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Timepoint [8]
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From first dose to 30 days post last dose (Up to 52 weeks)
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Secondary outcome [9]
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Number of Participants With Abnormalities in Electrocardiograms (ECGs)
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Assessment method [9]
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Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
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Timepoint [9]
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From baseline to up to week 48
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Secondary outcome [10]
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BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
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Assessment method [10]
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Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
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Timepoint [10]
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Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
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Secondary outcome [11]
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BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
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Assessment method [11]
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Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
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Timepoint [11]
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Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
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Secondary outcome [12]
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BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
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Assessment method [12]
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Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
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Timepoint [12]
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Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
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Secondary outcome [13]
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Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
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Assessment method [13]
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Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
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Timepoint [13]
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From baseline to week 44
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Secondary outcome [14]
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Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
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Assessment method [14]
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Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
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Timepoint [14]
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0
From baseline to week 32
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Secondary outcome [15]
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Percent Change From Baseline in Complement Proteins C3 and C4 Levels
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Assessment method [15]
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Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
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Timepoint [15]
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From baseline to week 52
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Secondary outcome [16]
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Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
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Assessment method [16]
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Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
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Timepoint [16]
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From baseline to week 32
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Secondary outcome [17]
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Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
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Assessment method [17]
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Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
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Timepoint [17]
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From baseline to week 52
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Secondary outcome [18]
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Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
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Assessment method [18]
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Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
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Timepoint [18]
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From baseline to week 32
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Secondary outcome [19]
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Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
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Assessment method [19]
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Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following:
A 4-point or greater reduction from baseline in SLEDAI-2K score
No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade
No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
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Timepoint [19]
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At week 32
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/09/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/10/2021
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Sample size
Target
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Accrual to date
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Final
363
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Local Institution - 0241 - Maroochydore
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Recruitment hospital [2]
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Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment postcode(s) [1]
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4558 - Maroochydore
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Recruitment postcode(s) [2]
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3081 - Heidelberg West
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arkansas
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0
0
United States of America
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State/province [3]
0
0
California
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0
0
United States of America
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0
0
Connecticut
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0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Michigan
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Minnesota
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Mississippi
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Country [11]
0
0
United States of America
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State/province [11]
0
0
New York
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Country [12]
0
0
United States of America
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State/province [12]
0
0
North Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Oklahoma
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Pennsylvania
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Country [15]
0
0
United States of America
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State/province [15]
0
0
South Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Tennessee
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Texas
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Virginia
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Washington
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Country [20]
0
0
Argentina
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State/province [20]
0
0
Buenos Aires
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Country [21]
0
0
Argentina
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State/province [21]
0
0
Santa Fe
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Country [22]
0
0
Argentina
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State/province [22]
0
0
Tucuman
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Country [23]
0
0
Argentina
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State/province [23]
0
0
Cordoba
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Country [24]
0
0
Argentina
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State/province [24]
0
0
Mendoza
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Country [25]
0
0
Brazil
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State/province [25]
0
0
Bahia
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Country [26]
0
0
Brazil
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State/province [26]
0
0
Goias
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Country [27]
0
0
Brazil
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State/province [27]
0
0
Minas Gerais
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Country [28]
0
0
Brazil
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State/province [28]
0
0
Parana
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Country [29]
0
0
Brazil
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State/province [29]
0
0
RIO Grande DO SUL
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0
0
Brazil
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0
0
SAO Paulo
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0
0
Brazil
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0
Rio de Janeiro
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0
0
Brazil
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0
0
Sao Paulo
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0
0
Canada
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0
0
Alberta
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0
0
Canada
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0
0
Ontario
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0
0
Colombia
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0
0
Barranquilla
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0
0
Colombia
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0
Bogota
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0
0
Colombia
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0
Bucaramanga
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0
0
Colombia
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Cali
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0
0
Colombia
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Chia
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0
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Colombia
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0
0
Zipaquira
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0
0
Germany
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0
0
Berlin
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0
0
Germany
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0
Hannover
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0
0
Germany
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Mainz
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0
0
Hungary
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0
Budapest
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0
0
Hungary
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0
Debrecen
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Hungary
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0
Gyula
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0
0
Hungary
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0
Szeged
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0
0
Israel
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0
Haifa
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0
0
Israel
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0
0
Jerusalem
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0
0
Israel
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0
Kfar Saba
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0
0
Israel
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0
0
Petah Tikva
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0
0
Israel
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0
0
Tel-Hashomer
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0
0
Japan
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0
0
Chiba
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0
0
Japan
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State/province [54]
0
0
Fukuoka
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Country [55]
0
0
Japan
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State/province [55]
0
0
Hokkaido
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0
0
Japan
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0
0
Miyagi
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0
0
Japan
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0
0
Okinawa
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0
0
Japan
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0
0
Tochigi
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0
0
Japan
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0
0
Tokyo
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0
0
Japan
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State/province [60]
0
0
Ishikawa
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Country [61]
0
0
Korea, Republic of
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State/province [61]
0
0
Daegu
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0
0
Korea, Republic of
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State/province [62]
0
0
Daejeon
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0
0
Korea, Republic of
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State/province [63]
0
0
Gwangju
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Country [64]
0
0
Korea, Republic of
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State/province [64]
0
0
Incheon
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Country [65]
0
0
Korea, Republic of
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State/province [65]
0
0
Seoul
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Country [66]
0
0
Korea, Republic of
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State/province [66]
0
0
Suwon
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Country [67]
0
0
Mexico
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State/province [67]
0
0
Distrito Federal
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Country [68]
0
0
Mexico
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State/province [68]
0
0
Guanajuato
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Country [69]
0
0
Mexico
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State/province [69]
0
0
Jalisco
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Country [70]
0
0
Mexico
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State/province [70]
0
0
Nuevo LEON
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Country [71]
0
0
Mexico
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State/province [71]
0
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San Luis Potosi
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Stalowa Wola
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Warszawa
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Wroclaw
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Romania
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Brasov
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Bucuresti
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Galati
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Ramnicu Valcea
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kemerovo
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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
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Saint Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tolyatti
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Russian Federation
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Vladimir
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Yaroslavl
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A Coru
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Merida
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Spain
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Taipei
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Taoyuan
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Funding & Sponsors
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Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Summary
Brief summary
This study will investigate BMS-986165 to assess its effects in participants with systemic
lupus erythematosus (SLE).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03252587
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03252587
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