A Study of Guselkumab in Participants With Active Lupus Nephritis

Study Purpose

The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Currently receiving prednisone equivalent dose of 1 milligram per kilogram per day (mg/kg/day) or less than or equal to (<=) 60 mg/day, whichever is lower, or less.
Must be receiving prednisone equivalent of 10 mg/day or more at screening and randomization. Treated for greater than or equal to (>=) 6 weeks with stable dosing >=2 weeks before randomization.
  • - If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to randomization.
  • - Positive antinuclear antibody (ANA; >= 1:80 titer by central laboratory test) or positive anti-double-stranded deoxyribonucleic acid (dsDNA) test results at screening.
  • - Kidney biopsy documentation of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV within the last 6 months prior to screening or performed during screening.
  • - Urine Protein to Creatinine Ratio (UPCR) >= 1.0 milligram/milligram (mg/mg) assessed on 2 first morning urine void specimens during screening.
These 2 specimens do not need to be on consecutive days, however, 2 samples must be tested with UPCR >= 1.0 mg/mg in a row. The UPCR requirement must be met after at least 8 weeks of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) treatment, and after stable glucocorticoid dosing is achieved at the dose intended at time of randomization.

Exclusion Criteria:

  • - Comorbidities (other than lupus nephritis [LN], example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months.
  • - Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease.
  • - Received PO (orally) cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to randomization.
  • - History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening.
- History of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04376827
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Mexico, Poland, Russian Federation, Spain, Taiwan, Thailand, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis
Study Website: View Trial Website
Additional Details

Guselkumab is a monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production. It is used in treatment of psoriatic arthritis, generalized pustular psoriasis, erythrodermic psoriasis. Lupus is a heterogeneous autoimmune disease with lesions confined to skin (cutaneous lupus erythematosus [CLE]) to others that involve 1 or more vital internal organs (systemic lupus erythematosus [SLE]). Renal involvement due to SLE is termed lupus nephritis (LN). There is a high unmet need for new treatment options in LN that are safe and effective, especially new therapies that can provide improved long-term efficacy over currently available therapies. This study will evaluate safety and efficacy of guselkumab added to standard-of-care compared to placebo added to standard-of-care. Total duration of study is up to 68 weeks: a less than or equal to 8 week screening period, a 48 week double-blind treatment period, a 12 week safety follow-up period after last dose. Hypothesis of this study is that guselkumab plus standard-of-care is superior to placebo plus standard-of-care in participants with active LN as measured by the proportion of participants inducing at least a 50 percentage reduction of proteinuria with protocol specified steroid tapering regimen at Week 24. Safety assessments include Adverse event (AEs), clinical laboratory tests (hematology and chemistry), systolic and diastolic blood pressures over time, monitoring for hypersensitivity reactions, AEs temporally associated with infusion, injection-site reactions, suicidality assessment, and early detection of active tuberculosis (TB).

Arms & Interventions

Arms

Experimental: Guselkumab+Standard of Care

Participants will receive guselkumab Dose 1 intravenously (IV) at Weeks 0, 4 and 8 and guselkumab Dose 2 subcutaneous (SC) every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids.

Placebo Comparator: Placebo+Standard of Care

Participants will receive placebo IV at Weeks 0, 4 and 8 and placebo SC q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids.

Interventions

Drug: - Guselkumab Dose 1

Participants will receive guselkumab Dose 1 via IV administration.

Drug: - Placebo

Participants will receive placebo IV at Weeks 0, 4 and 8 (that is, 3 IV doses) and placebo SC q4w from Week 12 through Week 48.

Drug: - Guselkumab Dose 2

Participants will receive guselkumab Dose 2 via SC route.

Drug: - Standard-of-care treatment

Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Alabama at Birmingham, Birmingham, Alabama

Status

Not yet recruiting

Address

The University of Alabama at Birmingham

Birmingham, Alabama, 35294

Medvin Clinical Research, Covina, California

Status

Recruiting

Address

Medvin Clinical Research

Covina, California, 91722

UC San Diego, La Jolla, California

Status

Not yet recruiting

Address

UC San Diego

La Jolla, California, 92037

Academic Medical Research Institute, Los Angeles, California

Status

Recruiting

Address

Academic Medical Research Institute

Los Angeles, California, 90022

University of Colorado Denver, Aurora, Colorado

Status

Not yet recruiting

Address

University of Colorado Denver

Aurora, Colorado, 80045

Yale University, New Haven, Connecticut

Status

Withdrawn

Address

Yale University

New Haven, Connecticut, 06519

Gainesville, Florida

Status

Not yet recruiting

Address

University of Florida College of Medicine

Gainesville, Florida, 32610

Brooklyn, New York

Status

Not yet recruiting

Address

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201

Manhasset, New York

Status

Not yet recruiting

Address

The Feinstein Institute for Medical Research

Manhasset, New York, 11030

Piedmont Arthritis Clinic, PA, Greenville, South Carolina

Status

Not yet recruiting

Address

Piedmont Arthritis Clinic, PA

Greenville, South Carolina, 29601

Med Research, Inc., El Paso, Texas

Status

Recruiting

Address

Med Research, Inc.

El Paso, Texas, 79935

International Sites

Centro Médico Reumatológico (OMI), Buenos Aires, Argentina

Status

Recruiting

Address

Centro Médico Reumatológico (OMI)

Buenos Aires, , C1015ABO

Caba, Argentina

Status

Recruiting

Address

ARCIS Salud SRL (Aprillus asistencia e investigacion)

Caba, , 1046

Hospital Ramos Mejia, Caba, Argentina

Status

Recruiting

Address

Hospital Ramos Mejia

Caba, , 1221

Instituto Medico Strusberg SA, Cordoba, Argentina

Status

Recruiting

Address

Instituto Medico Strusberg SA

Cordoba, , 05000

Mendoza, Argentina

Status

Recruiting

Address

Instituto de Reumatologia - Ir Medical Center S.A.

Mendoza, , 5000

Sanatorio Parque, Rosario, Argentina

Status

Withdrawn

Address

Sanatorio Parque

Rosario, , 2000

Rosario, Argentina

Status

Recruiting

Address

Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

Rosario, , S2000DEJ

Centro Medico Privado de Reumatologia, San Miguel De Tucuman, Argentina

Status

Recruiting

Address

Centro Medico Privado de Reumatologia

San Miguel De Tucuman, , T4000AXL

Ciudad de Mexico, Mexico

Status

Not yet recruiting

Address

Centro de Investigación y Tratamiento Reumatológico S.C.

Ciudad de Mexico, , 11850

Guadalajara, Mexico

Status

Not yet recruiting

Address

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , 44280

Unidad Reumatologica las Americas S.C.P., Merida, Mexico

Status

Not yet recruiting

Address

Unidad Reumatologica las Americas S.C.P.

Merida, , 97000

Mexico City, Mexico

Status

Not yet recruiting

Address

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico City, , 14080

Consultorio de Reumatologia, Mexico, Mexico

Status

Not yet recruiting

Address

Consultorio de Reumatologia

Mexico, , 07760

San Luis Potosi, Mexico

Status

Not yet recruiting

Address

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosi, , 78290

Gdansk, Poland

Status

Recruiting

Address

Uniwersyteckie Centrum Medyczne, Klinika Nefrologii, Transplantologii i Chorób Wewnętrznych

Gdansk, , 80-952

Krakow, Poland

Status

Not yet recruiting

Address

Malopolskie Badania Kliniczne Sp. z o.o. Sp. k.

Krakow, , 30-040

Lodz, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

Lodz, , 90-153

Lublin, Poland

Status

Withdrawn

Address

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, , 20-954

Warszawa, Poland

Status

Not yet recruiting

Address

UCK WUM Katedra i Klinika Nefrologii, Dializoterapii i Chorób Wewnętrznych

Warszawa, , 02-097

Wroclaw, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Kliniczny we Wrocławiu

Wroclaw, , 50-556

LLL Medical Center Revma-Med, Kemerovo, Russian Federation

Status

Recruiting

Address

LLL Medical Center Revma-Med

Kemerovo, , 650070

Omsk Regional Clinical Hospital, Omsk, Russian Federation

Status

Not yet recruiting

Address

Omsk Regional Clinical Hospital

Omsk, , 644111

Orenburg State Medical University, Orenburg, Russian Federation

Status

Recruiting

Address

Orenburg State Medical University

Orenburg, , 460000

LLC Medical Sanitary Part No. 157, Saint-Petersburg, Russian Federation

Status

Recruiting

Address

LLC Medical Sanitary Part No. 157

Saint-Petersburg, , 196066

Hosp. Univ. A Coruña, A Coruña, Spain

Status

Recruiting

Address

Hosp. Univ. A Coruña

A Coruña, , 15006

Hosp. Univ. Vall D Hebron, Barcelona, Spain

Status

Recruiting

Address

Hosp. Univ. Vall D Hebron

Barcelona, , 08035

Hosp. Univ. de Basurto, Bilbao, Spain

Status

Recruiting

Address

Hosp. Univ. de Basurto

Bilbao, , 48013

Hosp. Univ. Infanta Leonor, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Infanta Leonor

Madrid, , 28031

Hosp. Univ. Ramon Y Cajal, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Ramon Y Cajal

Madrid, , 28034

Hosp. Univ. Fuenlabrada, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Fuenlabrada

Madrid, , 28942

Hosp. Clinico Univ. de Valencia, Valencia, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Valencia

Valencia, , 46010

Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Status

Recruiting

Address

Kaohsiung Veterans General Hospital

Kaohsiung, , 81362

China Medical University Hospital, Taichung, Taiwan

Status

Recruiting

Address

China Medical University Hospital

Taichung, , 40447

National Taiwan University Hospital, Taipei, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei, , 10002

Chang Gung Memorial Hospital, Taoyuan, Taiwan

Status

Recruiting

Address

Chang Gung Memorial Hospital

Taoyuan, , 33305

Bangkok, Thailand

Status

Recruiting

Address

Phramongkutklao Hospital and Medical College

Bangkok, , 10400

Ramathibodi Hospital, Bangkok, Thailand

Status

Recruiting

Address

Ramathibodi Hospital

Bangkok, , 10400

Maharaj Nakorn Chiangmai Hospital, Chiang Mai, Thailand

Status

Recruiting

Address

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, , 50200

Songklanagarind hospital, Hat Yai, Thailand

Status

Recruiting

Address

Songklanagarind hospital

Hat Yai, , 90110

Cherkasy, Ukraine

Status

Recruiting

Address

Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council'

Cherkasy, , 18009

Kharkiv, Ukraine

Status

Recruiting

Address

Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, , 61058

City Clinical Hospital No. 2, Kryvyi Rih, Ukraine

Status

Recruiting

Address

City Clinical Hospital No. 2

Kryvyi Rih, , 50056

Kyiv, Ukraine

Status

Not yet recruiting

Address

Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC

Kyiv, , 02000

Kyiv, Ukraine

Status

Recruiting

Address

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, , 03049

Kyiv, Ukraine

Status

Recruiting

Address

SI 'National Scientific Center "Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine

Kyiv, , 03680

Medical Center 'Consylium Medical', Kyiv, Ukraine

Status

Recruiting

Address

Medical Center 'Consylium Medical'

Kyiv, , 04050

Kyiv, Ukraine

Status

Recruiting

Address

State Institution 'Institute of Nephrology of the National Academy of Medical Sciences of Ukraine'

Kyiv, , 04050

Lviv, Ukraine

Status

Not yet recruiting

Address

Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

Lviv, , 79010

Odessa, Ukraine

Status

Recruiting

Address

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odessa, , 65025

Odessa, Ukraine

Status

Recruiting

Address

Multidisciplinary Medical Center of Odessa National Medical University (University Clinic №1)

Odessa, , 65026

Ternopil, Ukraine

Status

Recruiting

Address

Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council

Ternopil, , 46002

Vinnytsya, Ukraine

Status

Recruiting

Address

Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

Vinnytsya, , 21009

Medical Center LLC 'Modern Clinic', Zaporizhzhya, Ukraine

Status

Not yet recruiting

Address

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, , 69600