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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03943147

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted October 14, 2020

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:Lupus Nephritis
  • Intervention/Treatment: Drug: BMS-986165
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 78 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • 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 2019
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: January 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. Change form baseline in 36-item Short Form Health Questionnaire (SF-36) [ Time Frame: At Week 24 and Week 52 ]
  • 2. Partial renal response (PRR) [ Time Frame: At Week 52 ]
  • 3. Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) [ Time Frame: At Week 24 and Week 52 ]
  • 4. Complete renal response (CRR) [ Time Frame: At Week 24 and Week 52 ]
  • 5. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 24 and Week 52 ]
  • 6. 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 ]
  • 7. Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  • 8. Urine Protein:Creatinine Ratio (UPCR) ≤ 0.7 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  • 9. Change from baseline in Serum Creatinine [ Time Frame: At Week 24 and Week 52 ]
  • 10. Change from baseline in estimated glomerular filtration rate [ Time Frame: At Week 24 and Week 52 ]
  • 11. Change from baseline in serum Albumin [ Time Frame: At Week 24 and Week 52 ]
  • 12. Change from baseline in 24 hour UPCR [ Time Frame: At Week 24 and Week 52 ]
  • 13. CRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  • 14. PRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  • 15. CRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  • 16. PRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  • 17. Incidence of renal systemic lupus erythematosus (SLE) flare [ Time Frame: Up to Week 52 ]
Eligibility Criteria
  • Ages Eligible for Study: 18 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

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
Show 155 Study Locations
Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information
  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03943147 History of Changes
  • Other Study ID Numbers: IM011-073, 2018-004142-42
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: October 14, 2020
  • Last Verified: October 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lupus Nephritis Nephritis