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An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT03943147
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date January 27, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Incidence of adverse events [ Time Frame: 73 Weeks ]
  • Incidence of laboratory abnormalites [ Time Frame: 73 Weeks ]
  • Partial Renal Response (PRR) [ Time Frame: At Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Incidence of adverse events [ Time Frame: 73 Weeks ]
  • Incidence of laboratory abnormalities [ Time Frame: 73 Weeks ]
  • Partial Renal Response (PRR) [ Time Frame: At Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
  • Complete renal response (CRR) [ Time Frame: At Week 24 and Week 52 ]
  • CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 24 and Week 52 ]
  • Partial renal response (PRR) [ Time Frame: At Week 52 ]
  • Mean Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) [ Time Frame: At Week 24 and Week 52 ]
  • Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  • Urine Protein:Creatinine Ratio (UPCR) ≤ 0.7 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  • Change from baseline in Serum Creatinine [ Time Frame: At Week 24 and Week 52 ]
  • Change from baseline in estimated glomerular filtration rate [ Time Frame: At Week 24 and Week 52 ]
  • Change from baseline in serum Albumin [ Time Frame: At Week 24 and Week 52 ]
  • Change from baseline in 24 hour UPCR [ Time Frame: At Week 24 and Week 52 ]
  • CRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  • PRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  • CRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  • PRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  • Incidence of renal systemic lupus erythematosus (SLE) flare [ Time Frame: Up to Week 52 ]
  • Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) [ Time Frame: At Week 24 and Week 52 ]
  • Change form baseline in 36-item Short Form Health Questionnaire (SF-36) [ Time Frame: At Week 24 and Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Complete renal response (CRR) [ Time Frame: At Week 24 ]
  • Complete renal response (CRR) [ Time Frame: At Week 52 ]
  • CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 24 ]
  • CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 52 ]
  • Partial renal response (PRR) [ Time Frame: At Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of BMS-986165compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind Study
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • Drug: BMS-986165
    Specified dose on specified days
  • Drug: Placebo
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Dose 1
    Specified Dose on Specified Days
    Intervention: Drug: BMS-986165
  • Experimental: Dose 2
    Specified Dose on Specified Days
    Intervention: Drug: BMS-986165
  • Placebo Comparator: Placebo
    Specified Dose on Specified Days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 27, 2023
Estimated Primary Completion Date January 27, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for SLE
  • Renal biopsy confirming a histologic diagnosis of active LN: International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V (in combination with Class III or IV)
  • Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg

Exclusion Criteria:

  • Pure ISN/RPS Class V membranous LN
  • Screening estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease [MDRD] equation) ≤30 mL/min/1.73 m2
  • Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Czechia,   Germany,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03943147
Other Study ID Numbers  ICMJE IM011-073
2018-004142-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP