| Primary | 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. | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | 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). | FAS included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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). | The Full Analyses Set for Week 52 (FASC52) included all randomized participants who received at least 1 dose of any study intervention and had the opportunity to complete the Week 52 visit prior to study termination. Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | | percentage of participants | | From Week 16 through Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | FASC52 included all randomized participants who received at least 1 dose of any study intervention and had the opportunity to complete the Week 52 visit prior to study termination. Here 'N' (number of participants analysed) signifies participants evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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). | FAS included all randomized participants who received at least 1 dose of any study intervention. | Posted | | Number | | Percentage of participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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). | FAS included all randomized participants who received at least 1 dose of any study intervention. | Posted | | Number | | Percentage of participants | | Up to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | Safety analysis set (SAS) included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Number of Participants With AEs Leading to Discontinuation of Study Intervention | Number of participants with AEs leading to discontinuation of study intervention were reported. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab |
|
| Secondary | Number of Participants With Infections | Number of participants with infections as assessed by the investigator were reported. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Number of Participants With Serious Infections | Number of participants with serious infections as assessed by the investigator were reported. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | 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. | SAS included all participants who received at least one dose of study intervention. For this outcome measure, no data was collected and analyzed due to premature termination of the study. | Posted | | | | | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time | Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported. | SAS included all participants who received at least one dose of study intervention. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants with available data for this OM. Since a small number of participants only entered LTE phase than planned enrollment count, planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM. | Posted | | Mean | Standard Deviation | Seconds | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Basophils | Change from baseline in clinical laboratory parameter: basophils was reported. | SAS included all subjects who received at least one dose of study intervention. Here 'n' (number analyzed) signifies number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies to number of participants with available data for this OM. Since a small number of participants only entered LTE phase than planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Eosinophils | Change from baseline in clinical laboratory parameter: eosinophils was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | petagram (pg) | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume | Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | femtoliter (fL) | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes | Change from baseline in clinical laboratory parameter: erythrocytes was reported. | SAS included all subjects who received at least one dose of study intervention. Here 'n' (number analyzed) signifies number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this OM. Since a small number of participants only entered the LTE phase than planned enrollment count, planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Hematocrit | Change from baseline in clinical Laboratory parameter: hematocrit was reported. | SAS included all participants who received at least one dose of study intervention. Here 'n' refers to the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this OM. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this OM. | Posted | | Mean | Standard Deviation | percentage of blood cells | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Hemoglobin | Change from baseline in clinical laboratory parameter: hemoglobin was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter Leukocytes | Change from baseline in clinical laboratory parameter: leukocytes was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Lymphocytes | Change from baseline in clinical laboratory parameter: lymphocytes was reported. | SAS population. Here 'n' (number analyzed) signifies to number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells per Liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Monocytes | Change from baseline in clinical laboratory parameter: monocytes was reported. | SAS population. Here 'n' (number analyzed) signifies to the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils | Change from baseline in clinical laboratory parameter: segmented neutrophils was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Platelets | Change from baseline in clinical laboratory parameter: platelets was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio | Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | Ratio | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time | Change from baseline in clinical laboratory parameter: prothrombin time was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | second | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes | Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of blood cells | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase | Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | Enzyme units per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Albumin | Change from baseline in clinical laboratory parameter: albumin was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | Grams per Liter (g/L) | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase | Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | Enzyme units per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase | Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | Enzyme units per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Bicarbonate | Change from baseline in clinical laboratory parameter: bicarbonate was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Bilirubin | Change from baseline in clinical laboratory parameter: bilirubin was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | micromole per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameters: Calcium | Change from baseline in clinical laboratory parameter: calcium was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Chloride | Change from baseline in clinical laboratory parameter: chloride was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameters: Cholesterol | Change from baseline in clinical laboratory parameter: cholesterol was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase | Change from baseline in clinical laboratory parameter: creatine kinase was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | Enzyme units per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Creatinine | Change from baseline in clinical laboratory parameter: creatinine was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | micromole per liter | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Protein | Change from baseline in clinical laboratory parameter: protein was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Phosphate | Change from baseline in clinical laboratory parameter: phosphate was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Sodium | Change from baseline in clinical laboratory parameter: sodium was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameters: Potassium | Change from baseline in clinical laboratory parameter: potassium was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen | Change from baseline in clinical laboratory parameter: urea nitrogen was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 24, and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | 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. | SAS population. Here 'n' (number analyzed) refers to the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | milliliter/minute/1.73 meter square | | Baseline (Week 0), Weeks 24 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 |
|
| Secondary | 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. | SAS population. Here 'n' (number analyzed) refers to the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | Enzyme units per liter | | Baseline (Week 0), Weeks 24 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Change from baseline in clinical laboratory parameter: glucose and magnesium were reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | millimoles per liter (mmol/L) | | Baseline, Weeks 24, 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Protein | Change from baseline in clinical laboratory parameter: protein was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | gram per Liter (g/L) | | Baseline (Week 0), Weeks 24 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Chemistry Parameters: Protein/Creatinine | Change from baseline in chemistry parameter: protein/creatinine was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | mg/mg | | Baseline, Weeks 24 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Urate | Change from baseline in clinical laboratory parameter: urate was reported. | SAS population. Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | micromole per liter | | Baseline, Weeks 24, 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Urine Protein | Change from baseline in clinical laboratory parameter: urine protein was reported. | SAS population.Here 'n' (number analyzed) signifies the number of participants evaluable at each specified timepoints. Here 'N' (number of participants analyzed) signifies the number of participants of both with available data for this outcome measure. Since a small number of participants only entered the LTE phase than the planned enrollment count, the planned analysis of change from baseline for the safety parameters was not performed for the LTE phase for this outcome measure. | Posted | | Mean | Standard Deviation | milligram per liter | | Baseline (Week 0), Weeks 24 and 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | |
|
| Secondary | 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. | SAS included all participants who received at least one dose of study intervention. Since a small number of participants only entered the LTE phase than the planned enrollment count, no separate adverse events analysis was performed for the LTE phase participants and thus, data of both DB period and LTE phase were presented together for this outcome measure under the arms: placebo and guselkumab. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | 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. | SAS included all participants who received at least one dose of study intervention. | Posted | | Number | | percentage of participants | | Up to Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | In double-blind period, participants received placebo matched to guselkumab (400 milligrams [mg]) intravenous (IV) infusion at Weeks 0, 4 and 8 and placebo matched to guselkumab (200 mg) subcutaneous (SC) injection 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 completed the Week 52 assessments entered the long-term extension (LTE) phase and continued to receive placebo matched to guselkumab SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). | | OG001 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
|
| Secondary | Serum Concentration of Guselkumab | Serum Concentration of guselkumab were reported. | Pharmacokinetic analysis set included all participants who received at least 1 administration of guselkumab and had at least one post-dose sample collection. Here 'n' (number analyzed) signifies number of participants evaluable at specified timepoints. Data for this OM was not planned to be collected and analyzed for placebo arm. Since small number of participants only entered LTE phase than the planned enrollment, planned serum concentration analysis was not performed for LTE phase for this OM. | Posted | | Mean | Standard Deviation | microgram/milliliter | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
| |
| Secondary | 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. | Immunogenecity analysis set inlcuded all participants who received at least 1 administration of guselkumab and had at least one post-dose sample collection. Here 'n' (number analyzed) signifies the number of participants evaluable at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for the placebo arm. | Posted | | Count of Participants | | Participants | | From Baseline (Week 0) through Week 24 and Week 60 | | | | ID | Title | Description |
|---|
| OG000 | Guselkumab | In double-blind period, participants received guselkumab 400 mg IV infusion at Weeks 0, 4, and 8 and guselkumab 200 mg SC injection q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved CRR at Week 48 and 52, and completed the Week 52 assessments entered LTE phase and continued to receive guselkumab 200 mg SC injection q4w from Week 52 through Week 84 (that is., up to LTE phase treatment termination). |
| |