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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/NCT03943147
Registration number
NCT03943147
Ethics application status
Date submitted
29/04/2019
Date registered
9/05/2019
Date last updated
17/10/2022
Titles & IDs
Public title
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
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Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis
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Secondary ID [1]
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2018-004142-42
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Secondary ID [2]
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IM011-073
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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:
Lupus Nephritis
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Treatment: Drugs - Placebo
Treatment: Drugs - Mycophenolate Mofetil
Experimental: BMS-986165 Dose 1 - Specified Dose on Specified Days
Experimental: BMS-986165 Dose 2 - Specified Dose on Specified Days
Placebo Comparator: Placebo for BMS-986165 - Specified Dose on Specified Days
Experimental: Mycophenolate Mofetil (MMF) - Specified Dose on Specified Days
Treatment: Drugs: BMS-986165
Specified dose on specified days
Treatment: Drugs: Placebo
Specified dose on specified days
Treatment: Drugs: Mycophenolate Mofetil
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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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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The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)
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Assessment method [1]
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An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
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Timepoint [1]
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From baseline up to 52 weeks after first dose in Part B
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Primary outcome [2]
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The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)
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Assessment method [2]
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The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
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Timepoint [2]
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From baseline up to 52 weeks after first dose in Part B
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Primary outcome [3]
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The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
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Assessment method [3]
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The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
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Timepoint [3]
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From baseline up to 52 weeks after first dose in Part B
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Primary outcome [4]
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The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)
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Assessment method [4]
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The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
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Timepoint [4]
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From baseline up to 52 weeks after first dose in Part B
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Primary outcome [5]
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Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)
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Assessment method [5]
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The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
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Timepoint [5]
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Week 24
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Secondary outcome [1]
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The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
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Assessment method [1]
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The number of participants with partial renal response (PRR) defined as = 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
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Assessment method [2]
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The number of participants with partial renal response (PRR) defined as = 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
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Assessment method [3]
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The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) = 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) = 60 mL/min or = 20% decrease from baseline.
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
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Assessment method [4]
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The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) = 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) = 60 mL/min or = 20% decrease from baseline.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to = 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B)
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Assessment method [5]
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The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) = 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) = 60 mL/min or = 20% decrease from baseline who was also able to successfully taper corticosteroid use to = 7.5 mg/day.
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to = 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B)
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Assessment method [6]
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The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) = 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) = 60 mL/min or = 20% decrease from baseline who was also able to successfully taper corticosteroid use to = 7.5 mg/day.
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Timepoint [6]
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Week 52
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)
criteria for Systemic Lupus Erythematosus (SLE)
- Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN)
International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III,
IV-S, or IV-G; or Class V
- Urine protein:creatinine ratio (UPCR) =1.5 mg/mg or UPCR =1 mg/mg assessed with a
24-hour urine specimen
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Minimum age
18
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Maximum age
75
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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
- Pure ISN/RPS Class V membranous LN
- Screening estimated glomerular filtration rate =30 mL/min/1.73 m^2
- Dialysis within 12 months before screening or plans for dialysis within 6 months after
enrollment in the study
- End-stage renal disease
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
Terminated
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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
15/07/2019
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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
17/09/2021
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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1871 - Liverpool
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared
with placebo with regard to measures of kidney function in participants with lupus nephritis
(LN).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03943147
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Trial related presentations / publications
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Public notes
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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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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03943147
Download to PDF