A Study of Guselkumab in Participants With Active Lupus Nephritis (ORCHID-LN)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis

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

Study Overview

• Status: Terminated
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2; Drug: Standard-of-care treatment; Drug: Placebo

Detailed Description

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 plaque psoriasis, 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. Participants who complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) of study through Week 152 and the 12-week safety follow-up visit. 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 events (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).

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Centro Médico Reumatológico (OMI)
  • Caba, Argentina, 1221
    • Hospital Ramos Mejia
  • Caba, Argentina, C1406AGA
    • ARCIS Salud SRL Aprillus asistencia e investigacion
  • Cordoba, Argentina, 05000
    • Instituto Medico Strusberg SA
  • Córdoba, Argentina, X5016LIG
    • Clínica Privada Velez Sarsfield
  • Mendoza, Argentina, 5000
    • Instituto de Reumatologia - Ir Medical Center S.A.
  • Rosario, Argentina, S2000DEJ
    • Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)
  • San Miguel De Tucuman, Argentina, T4000AXL
    • Centro de Investigaciones Médicas Tucuman
• Mexico
  • Ciudad de Mexico, Mexico, 11850
    • Centro de Investigacion y Tratamiento Reumatologico S C
  • Guadalajara, Mexico, 44280
    • Hospital Civil De Guadalajara Fray Antonio Alcalde
  • Merida, Mexico, 97000
    • Unidad Reumatologica las Americas S.C.P.
  • Mexico, Mexico, 07760
    • Consultorio de Reumatologia
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • San Luis Potosi, Mexico, 78290
    • Unidad de Investigaciones Reumatologicas A.C
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Medyczne, Klinika Nefrologii, Transplantologii i Chorób Wewnętrznych
  • Lodz, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny we Wrocławiu
• Russian Federation
  • Kemerovo, Russian Federation, 650070
    • LLL Medical Center Revma-Med
  • Orenburg, Russian Federation, 460000
    • Orenburg State Medical University
  • Saint-Petersburg, Russian Federation, 196066
    • LLC Medical Sanitary Part No. 157
  • Saratov, Russian Federation, 410053
    • Saratov Regional Clinical Hospital
  • St. Petersburg, Russian Federation, 196070
    • LLC German Clinic
• Spain
  • A Coruña, Spain, 15006
    • Hosp. Univ. A Coruna
  • Barcelona, Spain, 08035
    • Hosp. Univ. Vall D Hebron
  • Bilbao, Spain, 48013
    • Hosp. Univ. de Basurto
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28031
    • Hosp. Univ. Infanta Leonor
  • Madrid, Spain, 28942
    • Hosp. Univ. Fuenlabrada
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Taiwan
  • Kaohsiung, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 33305
    • Chang Gung Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital and Medical College
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiangmai Hospital
  • Hat Yai, Thailand, 90110
    • Songklanagarind Hospital
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • Kharkiv, Ukraine, 61058
    • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Kryvyi Rih, Ukraine, 50056
    • City Clinical Hospital No. 2
  • Kyiv, Ukraine, 02000
    • Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
  • Kyiv, Ukraine, 03049
    • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • Kyiv, Ukraine, 03680
    • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • Kyiv, Ukraine, 04050
    • Medical Center 'Consylium Medical'
  • Kyiv, Ukraine, 04050
    • State Institution 'Institute of Nephrology of the National Academy of Medical Sciences of Ukraine'
  • Odessa, Ukraine, 65025
    • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
  • Odessa, Ukraine, 65026
    • Multidisciplinary Medical Center of Odessa National Medical University
  • Ternopil, Ukraine, 46002
    • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
  • Vinnytsia, Ukraine, 21018
    • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
  • Vinnytsya, Ukraine, 21009
    • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
  • Zaporizhzhya, Ukraine, 69600
    • Medical Center LLC 'Modern Clinic'
• United States
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research
    • La Jolla, California, United States, 92037
      • UC San Diego
    • Los Angeles, California, United States, 90022
      • Academic Medical Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
  • New York
    • Brooklyn, New York, United States, 11201
      • NYU Langone Ambulatory Care Brooklyn Heights
    • Manhasset, New York, United States, 11030
      • The Feinstein Institute for Medical Research
  • Texas
    • El Paso, Texas, United States, 79902
      • Med Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At screening and randomization, must be receiving oral glucocorticoids at minimum prednisone equivalent dose of 10 milligrams per day (mg/day) and maximum 1 mg/kg/day or less than or equal to (<=) 60 mg/day, whichever is lower. 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 anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies (>=30 international units per milliliter ([U/mL] by central laboratory test) detected at screening
• Kidney biopsy documentation of active International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV (with or without class V membranous nephritis) 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) or intravenously (IV) cyclophosphamide within 3 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the long-term extension (LTE).	Drug: Guselkumab Dose 1; Participants will receive guselkumab Dose 1 via IV administration.; Other Names: CNTO 1959; Drug: Guselkumab Dose 2; Participants will receive guselkumab Dose 2 via SC route.; Other Names: CNTO1959; Drug: Standard-of-care treatment; Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
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. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the LTE of the study.	Drug: Standard-of-care treatment; Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24	Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 was reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24	Percentage of participants who achieved CRR at Week 24 were reported. CRR was defined as UPCR less than (<) 0.5 milligrams per milligrams (mg/mg), estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) or no confirmed decrease >=20% from baseline and prednisone dose less than or equal to (<=) 10 milligrams per day (mg/d). Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure (OM) time point (Week 24) or initiation of prohibited medications at any time prior to the endpoint time point (Week 24).	Week 24
Percentage of Participants Who Achieved CRR at Week 52	Percentage of participants who achieved CRR at Week 52 were reported. CRR was defined as UPCR less than (<) 0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease >=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).	Week 52
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24	Percentage of participants achieving a sustained reduction in steroid dose less than or equal to (<=) 10 mg/day of prednisone or equivalent from week 16 through Week 24were reported.	From Week 16 through Week 24
Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52	Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 52 were reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.	Week 52
Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24	Percentage of participants with UPCR <0.5 mg/mg at Week 24 were reported.	Week 24
Percentage of Participants With UPCR < 0.75 mg/mg at Week 24	Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported.	Week 24
Percentage of Participants Who Achieved CRR Through Week 24	Percentage of participants who achieved CRR through Week 24 was reported. CRR was defined as UPCR<0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease>=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to lupus nephritis (LN) or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 24) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 24).	Up to Week 24
Percentage of Participants With Treatment Failure (TF) Through Week 52	Percentage of participants with TF through Week 52 was reported. TF was defined as time to the first occurrence of TF from baseline. Participant was considered to have treatment failure, who did not continue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).	Up to Week 52
Number of Participants With Adverse Events (AEs)	Number of participants with AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Serious Adverse Events (SAEs)	Number of Participants with SAEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Related AEs	Number of participants with related AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Related AE was defined as the AE assessed by the investigator related to study agent.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With AEs Leading to Discontinuation of Study Intervention	Number of participants with AEs leading to discontinuation of study intervention were reported.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Infections	Number of participants with infections as assessed by the investigator were reported.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Serious Infections	Number of participants with serious infections as assessed by the investigator were reported.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With Infections Requiring Oral or Parenteral Antimicrobial Treatment	Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With AEs Temporally Associated With an Infusion	Number of participants with AEs temporally (a reaction that occurred during or within 1 hour after infusion) associated with an infusion were reported. AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Number of Participants With AEs With Injection-site Reactions	Number of participants with injection-site reactions as assessed by the investigator were reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time	Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Basophils	Change from baseline in clinical laboratory parameter: basophils was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Eosinophils	Change from baseline in clinical laboratory parameter: eosinophils was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin	Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume	Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Erythrocytes	Change from baseline in clinical laboratory parameter: erythrocytes was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Hematocrit	Change from baseline in clinical Laboratory parameter: hematocrit was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Hemoglobin	Change from baseline in clinical laboratory parameter: hemoglobin was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter Leukocytes	Change from baseline in clinical laboratory parameter: leukocytes was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Lymphocytes	Change from baseline in clinical laboratory parameter: lymphocytes was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Monocytes	Change from baseline in clinical laboratory parameter: monocytes was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils	Change from baseline in clinical laboratory parameter: segmented neutrophils was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Platelets	Change from baseline in clinical laboratory parameter: platelets was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio	Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time	Change from baseline in clinical laboratory parameter: prothrombin time was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes	Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase	Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Albumin	Change from baseline in clinical laboratory parameter: albumin was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase	Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase	Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Bicarbonate	Change from baseline in clinical laboratory parameter: bicarbonate was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Bilirubin	Change from baseline in clinical laboratory parameter: bilirubin was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Calcium	Change from baseline in clinical laboratory parameter: calcium was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Chloride	Change from baseline in clinical laboratory parameter: chloride was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Cholesterol	Change from baseline in clinical laboratory parameter: cholesterol was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase	Change from baseline in clinical laboratory parameter: creatine kinase was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Creatinine	Change from baseline in clinical laboratory parameter: creatinine was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Protein	Change from baseline in clinical laboratory parameter: protein was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Phosphate	Change from baseline in clinical laboratory parameter: phosphate was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Sodium	Change from baseline in clinical laboratory parameter: sodium was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Potassium	Change from baseline in clinical laboratory parameter: potassium was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen	Change from baseline in clinical laboratory parameter: urea nitrogen was reported.	Baseline (Week 0), Week 24, and Week 52
Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)	Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported.	Baseline (Week 0), Weeks 24 and 52
Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase	Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported.	Baseline (Week 0), Weeks 24 and 52
Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium	Change from baseline in clinical laboratory parameter: glucose and magnesium were reported.	Baseline, Weeks 24, 52
Change From Baseline in Clinical Laboratory Parameter: Protein	Change from baseline in clinical laboratory parameter: protein was reported.	Baseline (Week 0), Weeks 24 and 52
Change From Baseline in Chemistry Parameters: Protein/Creatinine	Change from baseline in chemistry parameter: protein/creatinine was reported.	Baseline, Weeks 24 and 52
Change From Baseline in Clinical Laboratory Parameter: Urate	Change from baseline in clinical laboratory parameter: urate was reported.	Baseline, Weeks 24, 52
Change From Baseline in Clinical Laboratory Parameter: Urine Protein	Change from baseline in clinical laboratory parameter: urine protein was reported.	Baseline (Week 0), Weeks 24 and 52
Number of Participants With Maximum US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Toxicity Grade (Grade 4) in Clinical Laboratory Parameters: Hematology and Chemistry	Number of participants with maximum US NCI-CTCAE toxicity grade (Grade 4) in clinical laboratory parameters: hematology and chemistry were reported. Toxicity were graded as Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.	DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure	Percentage of participants with abnormal vital signs: Systolic and Diastolic blood pressure were reported.	Up to Week 60
Serum Concentration of Guselkumab	Serum Concentration of guselkumab were reported.	Predose: Weeks 0,4,8,12,16,20,24, 36; Post-dose: Week 0 (1 hour after intravenous administration), Day 2, Week 52 and 60
Number of Participants With Treatment-boosted Anti-drug Antibodies (ADA) Response	Treatment-boosted ADA positive participants: participants who were positive at baseline and whose titers increased 2-fold at any time after treatment. Titer values were categorized as<=1:10, 10 to 100, 100 to 1000, >1000.	From Baseline (Week 0) through Week 24 and Week 60

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Lupus Nephritis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CR108766; 2018-003155-38 (EudraCT Number); CNTO1959LUN2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes