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Lupus NephritisPhase 2NCT03943147

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

A Phase 2 study testing BMS-986165 and Mycophenolate Mofetil in people with Lupus Nephritis, run by Bristol-Myers Squibb at 100 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Nephritis
What is being tested?
BMS-986165 and Mycophenolate Mofetil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
100 sitesin 16 countries
Study dates
15 Jul 2019to 17 Sep 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

100 sites in 16 countries.

100 sites in 16 countries

United States40 sites

  • Emory University

    Atlanta, Georgia, 30303

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

  • Johns Hopkins University, Office of Research Administration

    Baltimore, Maryland, 21205

  • Northeast Clinical Research Center

    Bethlehem, Pennsylvania, 18017

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Brighton Center for Specialty Care

    Brighton, Michigan, 48116

  • Local Institution - 0030

    Charleston, South Carolina, 29425

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611-5966

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43210

  • Nephrotex Research Group

    Dallas, Texas, 75231

  • Dallas Nephrology Associates - North Office

    Dallas, Texas, 75240

  • El Paso Medical Research Institute

    El Paso, Texas, 79902

  • Nephrology Associates of Northern Illinois and Indiana - Fort Wayne

    Fort Wayne, Indiana, 46804

  • NewYork-Presbyterian Queens

    Fresh Meadows, New York, 11365

  • The Nephrology Group

    Fresno, California, 93720

  • Local Institution - 0029

    Gainesville, Florida, 32603

  • Northwell Health Physician Partners at Great Neck

    Great Neck, New York, 11021

  • East Carolina University Physicians

    Greenville, North Carolina, 27834

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Clinical Research Consultants - Kansas City

    Kansas City, Missouri, 64111

  • Atlanta Nephrology Referral Center

    Lawrenceville, Georgia, 30046

  • The Regents of The University of California

    Los Angeles, California, 90095

  • Office of Ramesh C. Gupta, MD

    Memphis, Tennessee, 38119

  • Local Institution - 0039

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Local Institution - 0066

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of Utah

    Salt Lake City, Utah, 84132

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington School of Medicine

    Seattle, Washington, 98195-6340

  • Renal and Transplant Associates of New England, PC

    Springfield, Massachusetts, 01107

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Institute for Rheumatic and Autoimmune Diseases

    Summit, New Jersey, 07901

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210-2342

Other trials in United States

Mexico8 sites

  • Servicios Hospitalarios de Mexico

    Chihuahua City, 31217

  • Centro Integral de Reumatologia

    Guadalajara, Jalisco, 44160

  • Morales Vargas Centro de Investigacion

    León, Guanajuato, 37000

  • Unidad de Investigacion de las Enfermedades Reumaticas

    Mexico City, Mexico City, 06090

  • Local Institution - 0094

    Mexico City, Mexico City, 11850

  • Centro de Atencion e Investigacion Cardiovascular del Potosi

    San Luis Potosí City, 78200

  • Hospital Central Doctor Ignacio Morones Prieto

    San Luis Potosí City, 78240

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Zapopan, Jalisco, 45030

Other trials in Mexico

South Korea8 sites

  • Local Institution

    Busan, 602-715

  • Local Institution - 0071

    Daejeon, 35015

  • Local Institution - 0090

    Gwangju, 61469

  • Local Institution - 0056

    Seoul, 03080

  • Local Institution

    Seoul, 05030

  • Local Institution

    Seoul, 05505

  • Local Institution

    Seoul, 137-701

  • Local Institution

    Suwon, 442-723

Other trials in South Korea

Spain6 sites

  • Fundacio Puigvert

    Barcelona, 08025

  • Hospital Universitari Vall dHebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional Universitario de Malaga Hospital General

    Málaga, 29010

  • Hospital Universitario Nuestra Senora de Valme

    Seville, 41014

Other trials in Spain

United Kingdom6 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 5BE

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 2QQ

  • University Hospitals of Leicester NHS Trust

    Leicester, LE5 4PW

  • Barts Health NHS Trust

    London, E1 1BB

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

  • Epsom and Saint Helier University Hospitals NHS Trust

    Surrey, SM5 1AA

Other trials in United Kingdom

Taiwan5 sites

  • Local Institution

    Hualien City, 97002

  • Local Institution

    Kaohsiung City, 833

  • Local Institution

    Taichung, 40705

  • Local Institution - 0037

    Tainan, 71004

  • Local Institution

    Taipei, 112

Other trials in Taiwan

Italy4 sites

  • Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco

    Milan, 20157

  • Local Institution - 0082

    Milan, 20132

  • Universita degli Studi di Napoli Federico II

    Napo, 80131

  • Istituto Scientifico di Pavia

    Pavia, 27100

Other trials in Italy

Russia4 sites

  • Medical Center

    Kemerovo, 650070

  • City Clinical Hospital #15 named after O.M. Filatova

    Moscow, 111539

  • V.A. Nasonova Research Rheumatology Institute

    Moscow, 115522

  • Local Institution - 0015

    Saratov, 410053

Other trials in Russia

Canada3 sites

  • Sheldon M. Chumir Health Center

    Calgary, Alberta, T2N 4Z6

  • Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval

    Québec, Quebec, G1V 3M7

  • Toronto Western Hospital

    Toronto, Ontario, M5T 3A9

Other trials in Canada

Germany3 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131

Other trials in Germany

Israel3 sites

  • Local Institution

    Haifa, 3339419

  • Local Institution

    Kfar Saba, 4428164

  • Local Institution

    Tel Aviv, 6423906

Other trials in Israel

Australia2 sites

  • Liverpool Hospital

    Liverpool, New South Wales, 1871

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

Other trials in Australia

Belgium2 sites

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege Site Sart Tilman

    Liège, 4000

Other trials in Belgium

China2 sites

  • Local Institution

    Guangzhou, Guangdong, 510080

  • Local Institution

    Xi'an, Shan3xi, 710061

Other trials in China

Czechia2 sites

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 128 08

  • Revmatologicky Ustav

    Prague, 12850

Other trials in Czechia

Netherlands2 sites

  • Maastricht University Medical Centre

    Maastricht, 6229 HX

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

About this study

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

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).

Conditions
Lupus Nephritis
Being tested
BMS-986165, Placebo, Mycophenolate Mofetil
Medical subject headings
Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986165Drug

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

  • Mycophenolate MofetilDrug

    Specified dose on specified days

Study groups in NCT03943147
Study groupRoleWhat they receive
BMS-986165 Dose 1ExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986165; Drug: Mycophenolate Mofetil
BMS-986165 Dose 2ExperimentalSpecified Dose on Specified Days
Receives: Drug: BMS-986165; Drug: Mycophenolate Mofetil
Placebo for BMS-986165Placebo comparatorSpecified Dose on Specified Days
Receives: Drug: Placebo; Drug: Mycophenolate Mofetil
Mycophenolate Mofetil (MMF)ExperimentalSpecified Dose on Specified Days
Receives: Drug: Mycophenolate Mofetil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)

    An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

    Measured: From baseline up to 52 weeks after first dose in Part B

  2. The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)

    The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

    Measured: From baseline up to 52 weeks after first dose in Part B

  3. The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)

    The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

    Measured: From baseline up to 52 weeks after first dose in Part B

  4. The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)

    The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

    Measured: From baseline up to 52 weeks after first dose in Part B

  5. Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)

    The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.

    Measured: Week 24

Secondary outcomes (6)

  1. The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)

    The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.

    Measured: Week 24

  2. The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)

    The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.

    Measured: Week 52

  3. The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)

    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.

    Measured: Week 24

  4. The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)

    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.

    Measured: Week 52

  5. 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)

    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.

    Measured: Week 24

  6. 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)

    The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start15 Jul 2019
  3. Primary completion29 Oct 2020
  4. Study completion17 Sep 2021

Why it stopped: Insufficient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03943147
Sponsor's protocol ID
IM011-073
Other IDs
2018-004142-42, 2018
Status last verified
Sep 2022
First submitted
29 Apr 2019
Last updated
17 Oct 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986165 and Mycophenolate Mofetil in people with Lupus Nephritis, run by Bristol-Myers Squibb at 100 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Mexico, South Korea, Spain, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B) (time frame: From baseline up to 52 weeks after first dose in Part B). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03943147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.

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