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出境医 / 临床实验 / An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

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

Study Description
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
Arms and Interventions
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
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

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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