Clinical trial NCT03943147: An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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 Systemic Lupus Erythematosus (SLE)
* Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V
* Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen

Exclusion Criteria:

* Pure ISN/RPS Class V membranous LN
* Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m\^2
* Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study
* End-stage renal disease

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)
timeFrame: From baseline up to 52 weeks after first dose in Part B
measure: The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)
timeFrame: From baseline up to 52 weeks after first dose in Part B
measure: The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
timeFrame: From baseline up to 52 weeks after first dose in Part B
measure: The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)
timeFrame: From baseline up to 52 weeks after first dose in Part B
measure: Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)
timeFrame: Week 24
Secondary outcomes:
measure: The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
timeFrame: Week 24
measure: The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
timeFrame: Week 52
measure: The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
timeFrame: Week 24
measure: The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
timeFrame: Week 52
measure: The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B)
timeFrame: Week 24
measure: The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B)
timeFrame: Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fresno
country: United States
facility: The Nephrology Group
state: California
city: Los Angeles
country: United States
facility: The Regents of The University of California
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Gainesville
country: United States
facility: Local Institution - 0029
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Lawrenceville
country: United States
facility: Atlanta Nephrology Referral Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University, Office of Research Administration
state: Maryland
city: Springfield
country: United States
facility: Renal and Transplant Associates of New England, PC
state: Massachusetts
city: Brighton
country: United States
facility: Brighton Center for Specialty Care
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants - Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Summit
country: United States
facility: Institute for Rheumatic and Autoimmune Diseases
state: New Jersey
city: Fresh Meadows
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: Great Neck
country: United States
facility: Northwell Health Physician Partners at Great Neck
state: New York
city: New York
country: United States
facility: Local Institution - 0039
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Greenville
country: United States
facility: East Carolina University Physicians
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University, Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0066
state: Oklahoma
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Local Institution - 0030
state: South Carolina
city: Memphis
country: United States
facility: Office of Ramesh C. Gupta, MD
state: Tennessee
city: Dallas
country: United States
facility: Nephrotex Research Group
state: Texas
city: Dallas
country: United States
facility: Dallas Nephrology Associates - North Office
state: Texas
city: El Paso
country: United States
facility: El Paso Medical Research Institute
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege Site Sart Tilman
city: Calgary
country: Canada
facility: Sheldon M. Chumir Health Center
state: Alberta
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Quebec
country: Canada
facility: Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Xian
country: China
facility: Local Institution
state: Shan3xi
city: Praha 2
country: Czechia
facility: Revmatologicky Ustav
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice v Praze
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Haifa
country: Israel
facility: Local Institution
city: Kfar Saba
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution - 0082
city: Milan
country: Italy
facility: Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco
city: Napo
country: Italy
facility: Universita degli Studi di Napoli Federico II
city: Pavia
country: Italy
facility: Istituto Scientifico di Pavia
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daejeon
country: Korea, Republic of
facility: Local Institution - 0071
city: Gwangju
country: Korea, Republic of
facility: Local Institution - 0090
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0056
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution
city: Ciudad de Mexico
country: Mexico
facility: Unidad de Investigacion de las Enfermedades Reumaticas
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0094
state: Distrito Federal
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro Integral de Reumatologia
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
state: Jalisco
city: Chihuahua
country: Mexico
facility: Servicios Hospitalarios de Mexico
city: San Luis Potosi
country: Mexico
facility: Centro de Atencion e Investigacion Cardiovascular del Potosi
city: San Luis Potosi
country: Mexico
facility: Hospital Central Doctor Ignacio Morones Prieto
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Kemerovo
country: Russian Federation
facility: Medical Center
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #15 named after O.M. Filatova
city: Moscow
country: Russian Federation
facility: V.A. Nasonova Research Rheumatology Institute
city: Saratov
country: Russian Federation
facility: Local Institution - 0015
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Barcelona
country: Spain
facility: Hospital Universitari Vall dHebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga Hospital General
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Senora de Valme
city: Hualien
country: Taiwan
facility: Local Institution
city: Kaohsiung City
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution - 0037
city: Taipei
country: Taiwan
facility: Local Institution
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Surrey
country: United Kingdom
facility: Epsom and Saint Helier University Hospitals NHS Trust
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: