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

Primary Purpose

Lupus Nephritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Guselkumab Dose 1
Placebo
Guselkumab Dose 2
Standard-of-care treatment
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medvin Clinical Research
  • UC San Diego
  • Academic Medical Research Institute
  • University of Colorado Denver
  • University of Florida College of Medicine
  • NYU Langone Ambulatory Care Brooklyn Heights
  • The Feinstein Institute for Medical Research
  • Med Research, Inc.
  • Centro Médico Reumatológico (OMI)
  • Hospital Ramos Mejia
  • ARCIS Salud SRL (Aprillus asistencia e investigacion)
  • Instituto Medico Strusberg SA
  • Clinica Privada Velez Sarsfield
  • Instituto de Reumatologia - Ir Medical Center S.A.
  • Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)
  • Centro de Investigaciones Médicas Tucumán
  • Centro de Investigación y Tratamiento Reumatológico S.C.
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Unidad Reumatologica las Americas S.C.P.
  • Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
  • Consultorio de Reumatologia
  • Hospital Central Dr Ignacio Morones Prieto
  • Uniwersyteckie Centrum Medyczne, Klinika Nefrologii, Transplantologii i Chorób Wewnętrznych
  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
  • Uniwersytecki Szpital Kliniczny we Wrocławiu
  • LLL Medical Center Revma-Med
  • Orenburg State Medical University
  • LLC Medical Sanitary Part No. 157
  • Saratov Regional Clinical Hospital
  • LLC German Clinic
  • Hosp. Univ. A Coruña
  • Hosp. Univ. Vall D Hebron
  • Hosp. Univ. de Basurto
  • Hosp. Univ. Infanta Leonor
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. Univ. 12 De Octubre
  • Hosp. Univ. Fuenlabrada
  • Hosp. Clinico Univ. De Valencia
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital
  • Phramongkutklao Hospital and Medical College
  • Ramathibodi Hospital
  • Maharaj Nakorn Chiangmai Hospital
  • Songklanagarind hospital
  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • City Clinical Hospital No. 2
  • Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • Medical Center 'Consylium Medical'
  • State Institution 'Institute of Nephrology of the National Academy of Medical Sciences of Ukraine'
  • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
  • Multidisciplinary Medical Center of Odessa National Medical University
  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
  • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
  • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
  • Medical Center LLC 'Modern Clinic'

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Guselkumab+Standard of Care

Placebo+Standard of Care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving at Least 50 Percentage (%) Decrease in Proteinuria
Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 will be reported.

Secondary Outcome Measures

Percentage of Participants Achieving Complete Renal Response (CRR)
Percentage of participants achieving complete renal response will be reported.
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 milligram (mg)/day of Prednisone or Equivalent
Percentage of participants achieving a sustained reduction in steroid dose less than or equal to (<=) 10 mg/day of prednisone or equivalent will be reported.
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 will be reported.
Percentage of Participants Achieving Complete Renal Response
Percentage of participants achieving CRR will be reported.
Percentage of Participants with Urine Protein to Creatinine Ratio (UPCR) <0.5 mg/mg
Percentage of participants with UPCR <0.5 milligram/milligram (mg/mg) will be reported.
Percentage of Participants with UPCR < 0.75 mg/mg
Percentage of participants with UPCR less than (<) 0.75 mg/mg will be reported.
Time to achievement of Complete Renal Response
Time to achievement of CRR will be reported.
Time to Treatment Failure (TF)
Time to treatment failure will be reported. Treatment failure criteria include: initiation or increased use of a glucocorticoid or other immunosuppressive agents.
Number of Participants with Adverse Event (AE) serious adverse events (SAEs), reasonably related AEs, as a Measure of Safety and Tolerability
Number of Participants with Adverse Event (AE) serious adverse events (SAEs), reasonably related AEs will be assessed. 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. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is a suspected transmission of any infectious agent via a medicinal product.
Number of Participants with AE Leading to Discontinuation of Study Intervention
Number of participants with AE leading to discontinuation of study intervention will be 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.
Number of Participants with Infections
Number of participants with infections will be reported.
Number of Participants With Serious Infections
Number of Participants with serious infections will be reported.
Number of Participants with Infections Requiring Oral or Parenteral Antimicrobial Treatment
Number of participants with infections requiring oral or parenteral antimicrobial treatment will be reported.
Number of participants With AEs temporally associated with an infusion, and injection-site reactions
Number of participants with AEs temporally associated with an infusion, and injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site. 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.
Change From Baseline in Laboratory Parameters
Change from baseline in laboratory parameters (hematology and chemistry) will be reported.
Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values
Number of participants with maximum CTCAE toxicity grade laboratory values will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Systolic and Diastolic Blood Pressures Over Time
Systolic and diastolic blood pressures over time will be reported.
Serum Concentration of Guselkumab
Serum Concentration of guselkumab will be reported.
Number of Participants with Anti-Guselkumab Antibodies
Number of participants with anti-drug antibodies to guselkumab will be reported.

Full Information

First Posted
May 4, 2020
Last Updated
March 14, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04376827
Brief Title
A Study of Guselkumab in Participants With Active Lupus Nephritis
Acronym
ORCHID-LN
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guselkumab+Standard of Care
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo+Standard of Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab Dose 1
Other Intervention Name(s)
CNTO 1959
Intervention Description
Participants will receive guselkumab Dose 1 via IV administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab Dose 2
Other Intervention Name(s)
CNTO1959
Intervention Description
Participants will receive guselkumab Dose 2 via SC route.
Intervention Type
Drug
Intervention Name(s)
Standard-of-care treatment
Intervention Description
Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving at Least 50 Percentage (%) Decrease in Proteinuria
Description
Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 will be reported.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Complete Renal Response (CRR)
Description
Percentage of participants achieving complete renal response will be reported.
Time Frame
Week 24
Title
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 milligram (mg)/day of Prednisone or Equivalent
Description
Percentage of participants achieving a sustained reduction in steroid dose less than or equal to (<=) 10 mg/day of prednisone or equivalent will be reported.
Time Frame
Week 16 to Week 24
Title
Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52
Description
Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 52 will be reported.
Time Frame
Baseline and Week 52
Title
Percentage of Participants Achieving Complete Renal Response
Description
Percentage of participants achieving CRR will be reported.
Time Frame
Week 52
Title
Percentage of Participants with Urine Protein to Creatinine Ratio (UPCR) <0.5 mg/mg
Description
Percentage of participants with UPCR <0.5 milligram/milligram (mg/mg) will be reported.
Time Frame
Week 24
Title
Percentage of Participants with UPCR < 0.75 mg/mg
Description
Percentage of participants with UPCR less than (<) 0.75 mg/mg will be reported.
Time Frame
Week 24
Title
Time to achievement of Complete Renal Response
Description
Time to achievement of CRR will be reported.
Time Frame
Up to Week 52
Title
Time to Treatment Failure (TF)
Description
Time to treatment failure will be reported. Treatment failure criteria include: initiation or increased use of a glucocorticoid or other immunosuppressive agents.
Time Frame
Up to Week 52
Title
Number of Participants with Adverse Event (AE) serious adverse events (SAEs), reasonably related AEs, as a Measure of Safety and Tolerability
Description
Number of Participants with Adverse Event (AE) serious adverse events (SAEs), reasonably related AEs will be assessed. 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. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is a suspected transmission of any infectious agent via a medicinal product.
Time Frame
Up to Week 60
Title
Number of Participants with AE Leading to Discontinuation of Study Intervention
Description
Number of participants with AE leading to discontinuation of study intervention will be 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.
Time Frame
Up to Week 52
Title
Number of Participants with Infections
Description
Number of participants with infections will be reported.
Time Frame
Up to Week 60
Title
Number of Participants With Serious Infections
Description
Number of Participants with serious infections will be reported.
Time Frame
Up to Week 60
Title
Number of Participants with Infections Requiring Oral or Parenteral Antimicrobial Treatment
Description
Number of participants with infections requiring oral or parenteral antimicrobial treatment will be reported.
Time Frame
Up to Week 60
Title
Number of participants With AEs temporally associated with an infusion, and injection-site reactions
Description
Number of participants with AEs temporally associated with an infusion, and injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site. 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.
Time Frame
Up to Week 60
Title
Change From Baseline in Laboratory Parameters
Description
Change from baseline in laboratory parameters (hematology and chemistry) will be reported.
Time Frame
Up to Week 60
Title
Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values
Description
Number of participants with maximum CTCAE toxicity grade laboratory values will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Time Frame
Up to Week 60
Title
Systolic and Diastolic Blood Pressures Over Time
Description
Systolic and diastolic blood pressures over time will be reported.
Time Frame
Up to Week 60
Title
Serum Concentration of Guselkumab
Description
Serum Concentration of guselkumab will be reported.
Time Frame
Up to Week 60
Title
Number of Participants with Anti-Guselkumab Antibodies
Description
Number of participants with anti-drug antibodies to guselkumab will be reported.
Time Frame
Up to Week 160

10. Eligibility

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

12. IPD Sharing Statement

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

Learn more about this trial

A Study of Guselkumab in Participants With Active Lupus Nephritis

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