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

• ClinicalTrials.gov Identifier: NCT04376827
• Recruitment Status: Terminated
• First Posted: May 6, 2020
• Results First Posted: April 16, 2024
• Last Update Posted: April 16, 2024
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Lupus Nephritis	Drug: Guselkumab Dose 1; Drug: Placebo; Drug: Guselkumab Dose 2; Drug: Standard-of-care treatment	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis
• Actual Study Start Date: September 15, 2020
• Actual Primary Completion Date: February 1, 2023
• Actual Study Completion Date: February 1, 2023

Arms and Interventions

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 Name: CNTO 1959; Drug: Guselkumab Dose 2; Participants will receive guselkumab Dose 2 via SC route.; Other Name: 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: 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: Standard-of-care treatment; Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24 [ Time Frame: 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.

Secondary Outcome Measures :

1. Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24 [ Time Frame: 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).
2. Percentage of Participants Who Achieved CRR at Week 52 [ Time Frame: 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).
3. Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24 [ Time Frame: 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.
4. Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52 [ Time Frame: 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.
5. Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24 [ Time Frame: Week 24 ]
   Percentage of participants with UPCR <0.5 mg/mg at Week 24 were reported.
6. Percentage of Participants With UPCR < 0.75 mg/mg at Week 24 [ Time Frame: Week 24 ]
   Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported.
7. Percentage of Participants Who Achieved CRR Through Week 24 [ Time Frame: Up to 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).
8. Percentage of Participants With Treatment Failure (TF) Through Week 52 [ Time Frame: Up to 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).
9. Number of Participants With Adverse Events (AEs) [ Time Frame: 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 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.
10. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: 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 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.
11. Number of Participants With Related AEs [ Time Frame: 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 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.
12. Number of Participants With AEs Leading to Discontinuation of Study Intervention [ Time Frame: 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 were reported.
13. Number of Participants With Infections [ Time Frame: 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 as assessed by the investigator were reported.
14. Number of Participants With Serious Infections [ Time Frame: 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 as assessed by the investigator were reported.
15. Number of Participants With Infections Requiring Oral or Parenteral Antimicrobial Treatment [ Time Frame: 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 planned to be were reported.
16. Number of Participants With AEs Temporally Associated With an Infusion [ Time Frame: 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 (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.
17. Number of Participants With AEs With Injection-site Reactions [ Time Frame: 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 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.
18. Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported.
19. Change From Baseline in Clinical Laboratory Parameter: Basophils [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: basophils was reported.
20. Change From Baseline in Clinical Laboratory Parameter: Eosinophils [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: eosinophils was reported.
21. Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported.
22. Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported.
23. Change From Baseline in Clinical Laboratory Parameter: Erythrocytes [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: erythrocytes was reported.
24. Change From Baseline in Clinical Laboratory Parameter: Hematocrit [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical Laboratory parameter: hematocrit was reported.
25. Change From Baseline in Clinical Laboratory Parameter: Hemoglobin [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: hemoglobin was reported.
26. Change From Baseline in Clinical Laboratory Parameter Leukocytes [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: leukocytes was reported.
27. Change From Baseline in Clinical Laboratory Parameter: Lymphocytes [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: lymphocytes was reported.
28. Change From Baseline in Clinical Laboratory Parameter: Monocytes [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: monocytes was reported.
29. Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: segmented neutrophils was reported.
30. Change From Baseline in Clinical Laboratory Parameter: Platelets [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: platelets was reported.
31. Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported.
32. Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: prothrombin time was reported.
33. Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported.
34. Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported.
35. Change From Baseline in Clinical Laboratory Parameter: Albumin [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: albumin was reported.
36. Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported.
37. Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported.
38. Change From Baseline in Clinical Laboratory Parameter: Bicarbonate [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: bicarbonate was reported.
39. Change From Baseline in Clinical Laboratory Parameter: Bilirubin [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: bilirubin was reported.
40. Change From Baseline in Clinical Laboratory Parameters: Calcium [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: calcium was reported.
41. Change From Baseline in Clinical Laboratory Parameter: Chloride [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: chloride was reported.
42. Change From Baseline in Clinical Laboratory Parameters: Cholesterol [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: cholesterol was reported.
43. Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: creatine kinase was reported.
44. Change From Baseline in Clinical Laboratory Parameter: Creatinine [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: creatinine was reported.
45. Change From Baseline in Clinical Laboratory Parameter: Protein [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: protein was reported.
46. Change From Baseline in Clinical Laboratory Parameter: Phosphate [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: phosphate was reported.
47. Change From Baseline in Clinical Laboratory Parameter: Sodium [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: sodium was reported.
48. Change From Baseline in Clinical Laboratory Parameters: Potassium [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: potassium was reported.
49. Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen [ Time Frame: Baseline (Week 0), Week 24, and Week 52 ]
    Change from baseline in clinical laboratory parameter: urea nitrogen was reported.
50. Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) [ Time Frame: Baseline (Week 0), Weeks 24 and 52 ]
    Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported.
51. Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase [ Time Frame: Baseline (Week 0), Weeks 24 and 52 ]
    Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported.
52. Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium [ Time Frame: Baseline, Weeks 24, 52 ]
    Change from baseline in clinical laboratory parameter: glucose and magnesium were reported.
53. Change From Baseline in Clinical Laboratory Parameter: Protein [ Time Frame: Baseline (Week 0), Weeks 24 and 52 ]
    Change from baseline in clinical laboratory parameter: protein was reported.
54. Change From Baseline in Chemistry Parameters: Protein/Creatinine [ Time Frame: Baseline, Weeks 24 and 52 ]
    Change from baseline in chemistry parameter: protein/creatinine was reported.
55. Change From Baseline in Clinical Laboratory Parameter: Urate [ Time Frame: Baseline, Weeks 24, 52 ]
    Change from baseline in clinical laboratory parameter: urate was reported.
56. Change From Baseline in Clinical Laboratory Parameter: Urine Protein [ Time Frame: Baseline (Week 0), Weeks 24 and 52 ]
    Change from baseline in clinical laboratory parameter: urine protein was reported.
57. 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 [ Time Frame: 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 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.
58. Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure [ Time Frame: Up to Week 60 ]
    Percentage of participants with abnormal vital signs: Systolic and Diastolic blood pressure were reported.
59. Serum Concentration of Guselkumab [ Time Frame: 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 ]
    Serum Concentration of guselkumab were reported.
60. Number of Participants With Treatment-boosted Anti-drug Antibodies (ADA) Response [ Time Frame: From Baseline (Week 0) through Week 24 and Week 60 ]
    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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Medvin Clinical Research

Covina, California, United States, 91722

UC San Diego

La Jolla, California, United States, 92037

Academic Medical Research Institute

Los Angeles, California, United States, 90022

United States, Colorado

University of Colorado Denver

Aurora, Colorado, United States, 80045

United States, Florida

University of Florida College of Medicine

Gainesville, Florida, United States, 32610

United States, New York

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, United States, 11201

The Feinstein Institute for Medical Research

Manhasset, New York, United States, 11030

United States, Texas

Med Research, Inc.

El Paso, Texas, United States, 79902

Argentina

Centro Médico Reumatológico (OMI)

Buenos Aires, Argentina, C1015ABO

Hospital Ramos Mejia

Caba, Argentina, 1221

ARCIS Salud SRL Aprillus asistencia e investigacion

Caba, Argentina, C1406AGA

Instituto Medico Strusberg SA

Cordoba, Argentina, 05000

Clinica Privada Velez Sarsfield

Córdoba, Argentina, X5016LIG

Instituto de Reumatologia - Ir Medical Center S.A.

Mendoza, Argentina, 5000

Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

Rosario, Argentina, S2000DEJ

Centro de Investigaciones Medicas Tucuman

San Miguel De Tucuman, Argentina, T4000AXL

Mexico

Centro de Investigacion y Tratamiento Reumatologico S C

Ciudad de Mexico, Mexico, 11850

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico, 44280

Unidad Reumatologica las Americas S.C.P.

Merida, Mexico, 97000

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico City, Mexico, 14080

Consultorio de Reumatologia

Mexico, Mexico, 07760

Unidad de Investigaciones Reumatologicas A.C

San Luis Potosi, Mexico, 78290

Poland

Uniwersyteckie Centrum Medyczne, Klinika Nefrologii, Transplantologii i Chorób Wewnętrznych

Gdansk, Poland, 80-952

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

Lodz, Poland, 90-153

Uniwersytecki Szpital Kliniczny we Wrocławiu

Wroclaw, Poland, 50-556

Russian Federation

LLL Medical Center Revma-Med

Kemerovo, Russian Federation, 650070

Orenburg State Medical University

Orenburg, Russian Federation, 460000

LLC Medical Sanitary Part No. 157

Saint-Petersburg, Russian Federation, 196066

Saratov Regional Clinical Hospital

Saratov, Russian Federation, 410053

LLC German Clinic

St. Petersburg, Russian Federation, 196070

Spain

Hosp. Univ. A Coruna

A Coruña, Spain, 15006

Hosp. Univ. Vall D Hebron

Barcelona, Spain, 08035

Hosp. Univ. de Basurto

Bilbao, Spain, 48013

Hosp. Univ. Infanta Leonor

Madrid, Spain, 28031

Hosp. Univ. Ramon Y Cajal

Madrid, Spain, 28034

Hosp. Univ. 12 de Octubre

Madrid, Spain, 28041

Hosp. Univ. Fuenlabrada

Madrid, Spain, 28942

Hosp. Clinico Univ. de Valencia

Valencia, Spain, 46010

Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 81362

China Medical University Hospital

Taichung, Taiwan, 40447

National Taiwan University Hospital

Taipei, Taiwan, 10002

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 33305

Thailand

Phramongkutklao Hospital and Medical College

Bangkok, Thailand, 10400

Ramathibodi Hospital

Bangkok, Thailand, 10400

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, Thailand, 50200

Songklanagarind hospital

Hat Yai, Thailand, 90110

Ukraine

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, Ukraine, 18009

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

Kharkiv, Ukraine, 61058

City Clinical Hospital No. 2

Kryvyi Rih, Ukraine, 50056

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

Kyiv, Ukraine, 02000

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

Kyiv, Ukraine, 03049

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

Kyiv, Ukraine, 03680

Medical Center 'Consylium Medical'

Kyiv, Ukraine, 04050

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

Kyiv, Ukraine, 04050

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

Odessa, Ukraine, 65025

Multidisciplinary Medical Center of Odessa National Medical University

Odessa, Ukraine, 65026

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

Ternopil, Ukraine, 46002

MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'

Vinnytsia, Ukraine, 21018

Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

Vinnytsya, Ukraine, 21009

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, Ukraine, 69600

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

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

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol  [PDF] May 24, 2022

Statistical Analysis Plan  [PDF] August 16, 2022

More Information

Additional Information:

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

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04376827
• Other Study ID Numbers: CR108766; 2018-003155-38 ( EudraCT Number ); CNTO1959LUN2001 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: May 6, 2020
• Results First Posted: April 16, 2024
• Last Update Posted: April 16, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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
• URL: https://www.janssen.com/clinical-trials/transparency

• 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

Additional relevant MeSH terms:

Nephritis; Lupus Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs