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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 : June 4, 2019
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-986165 compared 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 : March 28, 2019
Estimated Primary Completion Date : July 7, 2021
Estimated Study Completion Date : July 7, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986165 Dose 1 oral administration Drug: BMS-986165
Specified dose on specified days
Experimental: BMS-986165 Dose 2 oral administration Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo oral administration 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 ]
  2. Complete renal response (CRR) [ Time Frame: At Week 52 ]
  3. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 24 ]
  4. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 52 ]
  5. Partial renal response (PRR) [ Time Frame: At 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 #.

  Show 103 Study Locations
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:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03943147     History of Changes
Other Study ID Numbers: IM011-073
2018-004142-42 ( EudraCT Number )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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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