A Phase 2 interventional study of Guselkumab Dose 1 and Placebo in Lupus Nephritis, sponsored by Janssen Research & Development, LLC. Terminated at 60 sites in 9 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
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).
245 studies on the registry are indexed under Nephritis; 56 are open to participants now.
This study's enrollment of 33 is below the median of 49 across 156 interventional studies indexed under Nephritis.
Browse Nephritis studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
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 · Drug: Guselkumab Dose 2 · Drug: Standard-of-care treatment
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 · Drug: Standard-of-care treatment
Participants will receive guselkumab Dose 1 via IV administration.
Also known as: CNTO 1959
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.
Participants will receive guselkumab Dose 2 via SC route.
Also known as: CNTO1959
Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
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.
Time frame: Week 24
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
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 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.
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
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.
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
Number of participants with AEs leading to discontinuation of study intervention were reported.
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
Number of participants with infections as assessed by the investigator were reported.
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
Number of participants with serious infections as assessed by the investigator were reported.
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
Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported.
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 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.
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 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.
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)
Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time
Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Weeks 24, 52
Change From Baseline in Clinical Laboratory Parameter: Protein
Change from baseline in clinical laboratory parameter: protein was reported.
Time frame: 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.
Time frame: Baseline, Weeks 24 and 52
Change From Baseline in Clinical Laboratory Parameter: Urate
Change from baseline in clinical laboratory parameter: urate was reported.
Time frame: Baseline, Weeks 24, 52
Change From Baseline in Clinical Laboratory Parameter: Urine Protein
Change from baseline in clinical laboratory parameter: urine protein was reported.
Time frame: 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.
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)
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.
Time frame: Up to Week 60
Serum Concentration of Guselkumab
Serum Concentration of guselkumab were reported.
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
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.
Time frame: From Baseline (Week 0) through Week 24 and Week 60
| Milestone | Placebo | Guselkumab |
|---|---|---|
| Started | 16 | 17 |
| Completed | 9 | 8 |
| Not completed | 7 | 9 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Study terminated by sponsor | 6 | 8 |
| Milestone | Placebo | Guselkumab |
|---|---|---|
| Started | 4 | 1 |
| Completed | 0 | 0 |
| Not completed | 4 | 1 |
| Withdrew: Protocol-specified withdrawal criterion met | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Study terminated by sponsor | 3 | 0 |
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.
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24 | 56.3 | 35.3 |
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).
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24 | 18.8 | 17.6 |
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).
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants Who Achieved CRR at Week 52 | 25.0 | 9.1 |
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.
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24 | 87.5 | 94.1 |
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.
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52 | 25.0 | 27.3 |
Percentage of participants with UPCR \<0.5 mg/mg at Week 24 were reported.
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24 | 25.0 | 29.4 |
Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported.
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants With UPCR < 0.75 mg/mg at Week 24 | 37.5 | 35.3 |
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).
| Percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants Who Achieved CRR Through Week 24 | 37.5 | 23.5 |
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).
| Percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Percentage of Participants With Treatment Failure (TF) Through Week 52 | 18.8 | 35.3 |
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.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 12 | 12 |
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.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 1 | 1 |
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.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With Related AEs | 2 | 2 |
Number of participants with AEs leading to discontinuation of study intervention were reported.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With AEs Leading to Discontinuation of Study Intervention | 1 | 2 |
Number of participants with infections as assessed by the investigator were reported.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With Infections | 5 | 6 |
Number of participants with serious infections as assessed by the investigator were reported.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With Serious Infections | 0 | 0 |
Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported.
No measurements were reported for this outcome.
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.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With AEs Temporally Associated With an Infusion | 1 | 0 |
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.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Number of Participants With AEs With Injection-site Reactions | 1 | 0 |
Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported.
| Seconds | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.78 ± 1.734 | 0.96 ± 3.869 |
| Week 52 | 0.88 ± 1.387 | — |
Change from baseline in clinical laboratory parameter: basophils was reported.
| 10^9 cells per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.009 ± 0.0512 | -0.009 ± 0.0502 |
| Week 52 | -0.070 ± 0.0990 | — |
Change from baseline in clinical laboratory parameter: eosinophils was reported.
| 10^9 cells per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.022 ± 0.0472 | -0.041 ± 0.1620 |
| Week 52 | 0.000 ± 0.0283 | — |
Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported.
| petagram (pg) | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.1 ± 1.38 | -0.8 ± 1.06 |
| Week 52 | -1.5 ± 2.12 | — |
Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported.
| femtoliter (fL) | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.5 ± 6.35 | -3.3 ± 5.37 |
| Week 52 | -4.0 ± 0.00 | — |
Change from baseline in clinical laboratory parameter: erythrocytes was reported.
| 10^12 cells per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.16 ± 0.582 | 0.12 ± 0.577 |
| Week 52 | -0.40 ± 0.566 | — |
Change from baseline in clinical Laboratory parameter: hematocrit was reported.
| percentage of blood cells | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.013 ± 0.0411 | -0.004 ± 0.0356 |
| Week 52 | -0.055 ± 0.0495 | — |
Change from baseline in clinical laboratory parameter: hemoglobin was reported.
| grams per liter (g/L) | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -5.2 ± 15.57 | -0.3 ± 14.82 |
| Week 52 | -17.0 ± 22.63 | — |
Change from baseline in clinical laboratory parameter: leukocytes was reported.
| 10^9 cells per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.622 ± 3.8729 | -1.157 ± 3.1246 |
| Week 52 | -5.120 ± 7.7499 | — |
Change from baseline in clinical laboratory parameter: lymphocytes was reported.
| 10^9 cells per Liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.006 ± 0.5213 | -0.032 ± 0.3860 |
| Week 52 | -0.545 ± 1.0960 | — |
Change from baseline in clinical laboratory parameter: monocytes was reported.
| 10^9 cells per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.014 ± 0.3277 | -0.002 ± 0.1268 |
| Week 52 | -0.510 ± 0.7354 | — |
Change from baseline in clinical laboratory parameter: segmented neutrophils was reported.
| 10^9 cells per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.630 ± 3.2494 | -1.074 ± 2.9652 |
| Week 52 | -3.990 ± 5.8548 | — |
Change from baseline in clinical laboratory parameter: platelets was reported.
| 10^9 cells per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -36.7 ± 61.43 | -17.8 ± 61.89 |
| Week 52 | -70.5 ± 67.18 | — |
Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported.
| Ratio | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.02 ± 0.090 | 0.01 ± 0.064 |
| Week 52 | 0.00 ± 0.000 | — |
Change from baseline in clinical laboratory parameter: prothrombin time was reported.
| second | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.18 ± 0.766 | 0.16 ± 0.425 |
| Week 52 | -0.03 ± 0.359 | — |
Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported.
| percentage of blood cells | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.0007 ± 0.00485 | -0.0001 ± 0.00541 |
| Week 52 | 0.0000 ± 0.01414 | — |
Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported.
| Enzyme units per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 2.6 ± 10.98 | -3.1 ± 6.57 |
| Week 52 | 2.3 ± 4.92 | — |
Change from baseline in clinical laboratory parameter: albumin was reported.
| Grams per Liter (g/L) | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 2.4 ± 5.57 | 1.9 ± 4.58 |
| Week 52 | 3.5 ± 5.32 | -3.0 ± NA |
Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported.
| Enzyme units per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 1.9 ± 16.75 | 1.7 ± 8.07 |
| Week 52 | 6.5 ± 5.00 | 6.0 ± NA |
Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported.
| Enzyme units per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.0 ± 4.97 | -0.7 ± 5.41 |
| Week 52 | 1.5 ± 2.38 | 1.0 ± NA |
Change from baseline in clinical laboratory parameter: bicarbonate was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.78 ± 4.97 | 0.21 ± 5.41 |
| Week 52 | -2.20 ± 2.38 | — |
Change from baseline in clinical laboratory parameter: bilirubin was reported.
| micromole per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.1 ± 1.98 | 0.3 ± 2.46 |
| Week 52 | -0.3 ± 2.06 | 4.0 ± NA |
Change from baseline in clinical laboratory parameter: calcium was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.039 ± 0.1172 | 0.073 ± 0.0958 |
| Week 52 | 0.000 ± 0.1871 | 0.010 ± NA |
Change from baseline in clinical laboratory parameter: chloride was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.1 ± 4.50 | 0.7 ± 0.0958 |
| Week 52 | 2.0 ± 4.83 | 2.0 ± NA |
Change from baseline in clinical laboratory parameter: cholesterol was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -1.325 ± 1.3026 | 0.017 ± 0.7818 |
| Week 52 | -2.235 ± 1.6588 | 0.210 ± NA |
Change from baseline in clinical laboratory parameter: creatine kinase was reported.
| Enzyme units per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 3.3 ± 42.22 | -0.5 ± 53.94 |
| Week 52 | -8.8 ± 36.65 | -2.0 ± NA |
Change from baseline in clinical laboratory parameter: creatinine was reported.
| micromole per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.6 ± 18.30 | 6.7 ± 16.78 |
| Week 52 | -3.3 ± 7.54 | -5.0 ± NA |
Change from baseline in clinical laboratory parameter: protein was reported.
| g/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 3.0 ± 8.83 | 2.9 ± 16.78 |
| Week 52 | 7.0 ± 7.39 | 1.0 ± NA |
Change from baseline in clinical laboratory parameter: phosphate was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.060 ± 0.1498 | 0.030 ± 0.2916 |
| Week 52 | -0.035 ± 0.2213 | 0.220 ± NA |
Change from baseline in clinical laboratory parameter: sodium was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -0.7 ± 2.30 | 0.4 ± 4.24 |
| Week 52 | 1.0 ± 1.41 | 3.0 ± NA |
Change from baseline in clinical laboratory parameter: potassium was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.19 ± 0.704 | 0.13 ± 0.402 |
| Week 52 | 0.03 ± 0.457 | 0.00 ± NA |
Change from baseline in clinical laboratory parameter: urea nitrogen was reported.
| mmol/L | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -1.23 ± 3.106 | 0.71 ± 2.177 |
| Week 52 | -1.60 ± 1.564 | 0.50 ± NA |
Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported.
| milliliter/minute/1.73 meter square | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 0.44 ± 21.639 | -5.87 ± 17.150 |
| Week 52 | 6.75 ± 22.588 | 5.60 ± NA |
Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported.
| Enzyme units per liter | Placebo | Guselkumab |
|---|---|---|
| gamma glutamyl transferase: Week 24 | -0.6 ± 15.01 | -3.0 ± 9.70 |
| gamma glutamyl transferase: Week 52 | 1.0 ± 8.60 | -2.0 ± NA |
| Lactate dehydogenase: Week 24 | -14.5 ± 47.90 | -2.5 ± 17.52 |
| Lactate dehydogenase: Week 52 | -62.5 ± 40.31 | 7.0 ± NA |
Change from baseline in clinical laboratory parameter: glucose and magnesium were reported.
| millimoles per liter (mmol/L) | Placebo | Guselkumab |
|---|---|---|
| Glucose: Week 24 | -0.23 ± 1.041 | -0.04 ± 0.908 |
| Glucose:: Week 52 | -0.03 ± 0.126 | 0.20 ± NA |
| Magnesium: Week 24 | -0.024 ± 0.0696 | -0.022 ± 0.0607 |
| Magnesium: Week 52 | -0.068 ± 0.0842 | -0.010 ± NA |
Change from baseline in clinical laboratory parameter: protein was reported.
| gram per Liter (g/L) | Placebo | Guselkumab |
|---|---|---|
| Week 24 | 3.0 ± 8.83 | 2.9 ± 6.55 |
| Week 52 | 7.0 ± 7.39 | 1.0 ± NA |
Change from baseline in chemistry parameter: protein/creatinine was reported.
| mg/mg | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -1.509 ± 1.9494 | -0.821 ± 2.4250 |
| Week 52 | -1.586 ± 1.7966 | -0.352 ± 1.6960 |
Change from baseline in clinical laboratory parameter: urate was reported.
| micromole per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -73.4 ± 104.11 | 8.4 ± 48.61 |
| Week 52 | -79.5 ± 79.38 | -2.0 ± NA |
Change from baseline in clinical laboratory parameter: urine protein was reported.
| milligram per liter | Placebo | Guselkumab |
|---|---|---|
| Week 24 | -1322.1 ± 1865.82 | -310.3 ± 1494.58 |
| Week 52 | -1821.7 ± 2334.78 | -166.4 ± 1099.54 |
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.
| Participants | Placebo | Guselkumab |
|---|---|---|
| Alanine Aminotransferase Increased | 0 | 0 |
| Alkaline Phosphatase Increased | 0 | 0 |
| Aspartate Aminotransferase Increased | 0 | 0 |
| Blood Bilirubin Increased | 0 | 0 |
| CPK Increased | 0 | 0 |
| Cholesterol High | 0 | 0 |
| Creatinine Increase | 0 | 0 |
| GGT Increased | 0 | 0 |
| Hypermagnesemia | 0 | 0 |
| Hypernatremia | 0 | 0 |
| Hypertriglyceridemia | 0 | 0 |
| Hypoalbuminemia | 0 | 0 |
| Hypoglycemia | 0 | 0 |
| Hypokalemia | 0 | 0 |
| Hypomagnesemia | 0 | 0 |
| Hyponatremia | 0 | 0 |
| Activated Partial Thromboplastin Time Prolonged | 0 | 0 |
| Anemia | 0 | 0 |
| Hemoglobin Increased | 0 | 0 |
| Leukocytosis | 0 | 0 |
| Lymphocyte Count Decreased | 0 | 0 |
| Lymphocyte Count Increased | 0 | 0 |
| Neutrophil Count Decreased | 0 | 0 |
| Platelet Count Decreased | 0 | 0 |
| White Blood Cell Decreased | 0 | 0 |
Percentage of participants with abnormal vital signs: Systolic and Diastolic blood pressure were reported.
| percentage of participants | Placebo | Guselkumab |
|---|---|---|
| Systolic Blood Pressure: <85 mmHg | 0 | 0 |
| Systolic Blood Pressure::>180 mmHg | 6.3 | 5.9 |
| Diastolic Blood Pressure: <55 mmHg | 6.3 | 0 |
| Diastolic Blood Pressure: >115 mmHg | 6.3 | 0 |
Serum Concentration of guselkumab were reported.
| microgram/milliliter | Guselkumab |
|---|---|
| Week 0, predose | 0.00 ± 0.000 |
| Week 0, 1h after IV administration | 146.20 ± 41.273 |
| Day 2, post-dose | 96.55 ± 33.805 |
| Week 4, predose | 11.20 ± 7.175 |
| Week 8, predose | 12.85 ± 9.549 |
| Week 12, predose | 18.17 ± 11.784 |
| Week 16, pre-dose | 9.89 ± 5.016 |
| Week 20, predose | 7.63 ± 4.689 |
| Week 24, predose | 6.42 ± 3.447 |
| Week 36, predose | 6.57 ± 1.827 |
| Week 52, post-dose | 6.13 ± 3.262 |
| Week 60, post-dose | 0.39 ± 0.641 |
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.
| Participants | Guselkumab |
|---|---|
| Week 24 | 1 |
| Week 60 | 1 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/16 (0%) | 1/16 (6.3%) | 12/16 (75%) |
| Guselkumab | 0/17 (0%) | 1/17 (5.9%) | 12/17 (70.6%) |
| Event | Placebo | Guselkumab |
|---|---|---|
| Basal Ganglia StrokeNervous system disorders | 1/16 | 0/17 |
| Lupus NephritisRenal and urinary disorders | 0/16 | 1/17 |
| Event | Placebo | Guselkumab |
|---|---|---|
| Lupus NephritisRenal and urinary disorders | 2/16 | 5/17 |
| LymphopeniaBlood and lymphatic system disorders | 3/16 | 0/17 |
| Covid-19Infections and infestations | 3/16 | 0/17 |
| AnaemiaBlood and lymphatic system disorders | 1/16 | 3/17 |
| LeukopeniaBlood and lymphatic system disorders | 2/16 | 0/17 |
| Abdominal Pain UpperGastrointestinal disorders | 2/16 | 0/17 |
| Herpes ZosterInfections and infestations | 2/16 | 1/17 |
| Urinary Tract InfectionInfections and infestations | 2/16 | 2/17 |
| HyperuricaemiaMetabolism and nutrition disorders | 2/16 | 1/17 |
| HypertensionVascular disorders | 2/16 | 2/17 |
| Age, Continuous(years) | Placebo | Guselkumab | Total |
|---|---|---|---|
| Mean | 38.8 ± 11.69 | 35.3 ± 10.07 | 37 ± 10.86 |
| Age, Customized(Participants) | Placebo | Guselkumab | Total |
|---|---|---|---|
| >= 55 years | 1 | 1 | 2 |
| < 55 years | 15 | 16 | 31 |
| Sex: Female, Male(Participants) | Placebo | Guselkumab | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Guselkumab | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 11 |
| Not Hispanic or Latino | 12 | 10 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Guselkumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 14 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | Guselkumab | Total |
|---|---|---|---|
| ARGENTINA | 5 | 4 | 9 |
| MEXICO | 1 | 3 | 4 |
| RUSSIAN FEDERATION | 2 | 1 | 3 |
| TAIWAN | 3 | 0 | 3 |
| THAILAND | 0 | 1 | 1 |
| UKRAINE | 5 | 7 | 12 |
| UNITED STATES | 0 | 1 | 1 |
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