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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2018-004142-42
Secondary ID [2] 0 0
IM011-073
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)
Timepoint [1] 0 0
From baseline up to 52 weeks after first dose in Part B
Primary outcome [2] 0 0
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)
Timepoint [2] 0 0
From baseline up to 52 weeks after first dose in Part B
Primary outcome [3] 0 0
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Timepoint [3] 0 0
From baseline up to 52 weeks after first dose in Part B
Primary outcome [4] 0 0
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)
Timepoint [4] 0 0
From baseline up to 52 weeks after first dose in Part B
Primary outcome [5] 0 0
Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)
Timepoint [5] 0 0
Week 24
Secondary outcome [1] 0 0
The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Week 52

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/09/2021
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Massachusetts
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Brighton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT03943147
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03943147