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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: BMS-986165 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind Study
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 27, 2023
Estimated Study Completion Date : January 27, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose 1
Specified Dose on Specified Days
 Drug: BMS-986165
Specified dose on specified days
Experimental: Dose 2
Specified Dose on Specified Days
 Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo
Specified Dose on Specified Days
 Drug: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 73 Weeks ]
  2. Incidence of laboratory abnormalites [ Time Frame: 73 Weeks ]
  3. Partial Renal Response (PRR) [ Time Frame: At Week 24 ]

Secondary Outcome Measures :
  1. Complete renal response (CRR) [ Time Frame: At Week 24 and Week 52 ]
  2. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 24 and Week 52 ]
  3. Partial renal response (PRR) [ Time Frame: At Week 52 ]
  4. 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 ]
  5. Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  6. Urine Protein:Creatinine Ratio (UPCR) ≤ 0.7 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  7. Change from baseline in Serum Creatinine [ Time Frame: At Week 24 and Week 52 ]
  8. Change from baseline in estimated glomerular filtration rate [ Time Frame: At Week 24 and Week 52 ]
  9. Change from baseline in serum Albumin [ Time Frame: At Week 24 and Week 52 ]
  10. Change from baseline in 24 hour UPCR [ Time Frame: At Week 24 and Week 52 ]
  11. CRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  12. PRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  13. CRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  14. PRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  15. Incidence of renal systemic lupus erythematosus (SLE) flare [ Time Frame: Up to Week 52 ]
  16. Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) [ Time Frame: At Week 24 and Week 52 ]
  17. Change form baseline in 36-item Short Form Health Questionnaire (SF-36) [ Time Frame: At Week 24 and Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943147


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03943147    
Other Study ID Numbers: IM011-073
2018-004142-42 ( EudraCT Number )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action