Lupus Nephritis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
Detailed description
Guselkumab is a monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting IL 23 specific intracellular signaling and subsequent activation and cytokine production. It is used in treatment of plaque psoriasis, psoriatic arthritis, generalized pustular psoriasis, erythrodermic psoriasis. Lupus is a heterogeneous autoimmune disease with lesions confined to skin (cutaneous lupus erythematosus \[CLE\]) to others that involve 1 or more vital internal organs (systemic lupus erythematosus \[SLE\]). Renal involvement due to SLE is termed lupus nephritis (LN). There is a high unmet need for new treatment options in LN that are safe and effective, especially new therapies that can provide improved long-term efficacy over currently available therapies. This study will evaluate safety and efficacy of guselkumab added to standard-of-care compared to placebo added to standard-of-care. Total duration of study is up to 68 weeks: a less than or equal to 8 week screening period, a 48 week double-blind treatment period, a 12 week safety follow-up period after last dose. Participants who complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) of study through Week 152 and the 12-week safety follow-up visit. Hypothesis of this study is that guselkumab plus standard-of-care is superior to placebo plus standard-of-care in participants with active LN as measured by the proportion of participants inducing at least a 50 percentage reduction of proteinuria with protocol specified steroid tapering regimen at Week 24. Safety assessments include Adverse events (AEs), clinical laboratory tests (hematology and chemistry), systolic and diastolic blood pressures over time, monitoring for hypersensitivity reactions, AEs temporally associated with infusion, injection-site reactions, suicidality assessment, and early detection of active tuberculosis (TB).
Interventions
Participants will receive guselkumab Dose 1 via IV administration.
DRUGPlacebo
Participants will receive placebo IV at Weeks 0, 4 and 8 (that is, 3 IV doses) and placebo SC q4w from Week 12 through Week 48.
Participants will receive guselkumab Dose 2 via SC route.
Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* At screening and randomization, must be receiving oral glucocorticoids at minimum prednisone equivalent dose of 10 milligrams per day (mg/day) and maximum 1 mg/kg/day or less than or equal to (\<=) 60 mg/day, whichever is lower. Treated for greater than or equal to (\>=) 6 weeks with stable dosing \>=2 weeks before randomization * If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to randomization * Positive antinuclear antibody (ANA; \>= 1:80 titer by central laboratory test) or anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies (\>=30 international units per milliliter (\[U/mL\] by central laboratory test) detected at screening * Kidney biopsy documentation of active International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV (with or without class V membranous nephritis) within the last 6 months prior to screening or performed during screening * Urine Protein to Creatinine Ratio (UPCR) \>= 1.0 milligram/milligram (mg/mg) assessed on 2 first morning urine void specimens during screening. These 2 specimens do not need to be on consecutive days, however, 2 samples must be tested with UPCR \>= 1.0 mg/mg in a row. The UPCR requirement must be met after at least 8 weeks of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) treatment, and after stable glucocorticoid dosing is achieved at the dose intended at time of randomization
Exclusion criteria
* Comorbidities (other than lupus nephritis \[LN\], example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months * Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease * Received PO (orally) or intravenously (IV) cyclophosphamide within 3 months prior to randomization * History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening * History of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24 | Week 24 | Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 was reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved CRR at Week 52 | 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). |
| Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24 | 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. |
| Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52 | 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. |
| Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24 | Week 24 | Percentage of participants with UPCR \<0.5 mg/mg at Week 24 were reported. |
| Percentage of Participants With UPCR < 0.75 mg/mg at Week 24 | Week 24 | Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported. |
| Percentage of Participants Who Achieved CRR Through Week 24 | Up to Week 24 | Percentage of participants who achieved CRR through Week 24 was reported. CRR was defined as UPCR\<0.5 mg/mg, eGFR \>= 60 mL/min/1.73m\^2 or no confirmed decrease\>=20% from baseline and prednisone dose \<= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to lupus nephritis (LN) or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 24) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 24). |
| Change From Baseline in Clinical Laboratory Parameter: Monocytes | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: monocytes was reported. |
| Percentage of Participants With Treatment Failure (TF) Through Week 52 | Up to Week 52 | Percentage of participants with TF through Week 52 was reported. TF was defined as time to the first occurrence of TF from baseline. Participant was considered to have treatment failure, who did not continue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52). |
| Number of Participants With Adverse Events (AEs) | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. |
| Number of Participants With Serious Adverse Events (SAEs) | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of Participants with SAEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. |
| Number of Participants With Related AEs | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with related AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Related AE was defined as the AE assessed by the investigator related to study agent. |
| Number of Participants With AEs Leading to Discontinuation of Study Intervention | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with AEs leading to discontinuation of study intervention were reported. |
| Number of Participants With Infections | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with infections as assessed by the investigator were reported. |
| Number of Participants With Serious Infections | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with serious infections as assessed by the investigator were reported. |
| Number of Participants With Infections Requiring Oral or Parenteral Antimicrobial Treatment | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported. |
| Number of Participants With AEs Temporally Associated With an Infusion | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with AEs temporally (a reaction that occurred during or within 1 hour after infusion) associated with an infusion were reported. AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. |
| Change From Baseline in Clinical Laboratory Parameter: Urine Protein | Baseline (Week 0), Weeks 24 and 52 | Change from baseline in clinical laboratory parameter: urine protein was reported. |
| Number of Participants With AEs With Injection-site Reactions | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with injection-site reactions as assessed by the investigator were reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site. |
| Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Basophils | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: basophils was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Eosinophils | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: eosinophils was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Erythrocytes | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: erythrocytes was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Hematocrit | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical Laboratory parameter: hematocrit was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Hemoglobin | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: hemoglobin was reported. |
| Change From Baseline in Clinical Laboratory Parameter Leukocytes | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: leukocytes was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Lymphocytes | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: lymphocytes was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: segmented neutrophils was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Platelets | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: platelets was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: prothrombin time was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Albumin | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: albumin was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Bicarbonate | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: bicarbonate was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Bilirubin | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: bilirubin was reported. |
| Change From Baseline in Clinical Laboratory Parameters: Calcium | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: calcium was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Chloride | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: chloride was reported. |
| Change From Baseline in Clinical Laboratory Parameters: Cholesterol | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: cholesterol was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: creatine kinase was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Creatinine | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: creatinine was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Protein | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: protein was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Phosphate | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: phosphate was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Sodium | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: sodium was reported. |
| Change From Baseline in Clinical Laboratory Parameters: Potassium | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: potassium was reported. |
| Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen | Baseline (Week 0), Week 24, and Week 52 | Change from baseline in clinical laboratory parameter: urea nitrogen was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Baseline (Week 0), Weeks 24 and 52 | Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | Baseline (Week 0), Weeks 24 and 52 | Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported. |
| Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24 | 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). |
| Change From Baseline in Chemistry Parameters: Protein/Creatinine | Baseline, Weeks 24 and 52 | Change from baseline in chemistry parameter: protein/creatinine was reported. |
| Change From Baseline in Clinical Laboratory Parameter: Urate | Baseline, Weeks 24, 52 | Change from baseline in clinical laboratory parameter: urate was reported. |
| 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 | DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96) | Number of participants with maximum US NCI-CTCAE toxicity grade (Grade 4) in clinical laboratory parameters: hematology and chemistry were reported. Toxicity were graded as Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death. |
| Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Up to Week 60 | Percentage of participants with abnormal vital signs: Systolic and Diastolic blood pressure were reported. |
| Serum Concentration of Guselkumab | Predose: Weeks 0,4,8,12,16,20,24, 36; Post-dose: Week 0 (1 hour after intravenous administration), Day 2, Week 52 and 60 | Serum Concentration of guselkumab were reported. |
| Number of Participants With Treatment-boosted Anti-drug Antibodies (ADA) Response | From Baseline (Week 0) through Week 24 and Week 60 | Treatment-boosted ADA positive participants: participants who were positive at baseline and whose titers increased 2-fold at any time after treatment. Titer values were categorized as\<=1:10, 10 to 100, 100 to 1000, \>1000. |
| Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Baseline, Weeks 24, 52 | Change from baseline in clinical laboratory parameter: glucose and magnesium were reported. |
Countries
Argentina, Mexico, Poland, Russia, Spain, Taiwan, Thailand, Ukraine, United States
Participant flow
Pre-assignment details
Randomization was stratified by geographic region (North America, Latin America, Asia Pacific and Europe) and Urine Protein to Creatinine Ratio (UPCR) level (less than \[\<\] 3 milligrams per milligram \[mg/mg\] and greater than or equal to \[\>=\] 3 mg/mg).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 16 |
| 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). | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double Blind Period: Week 0 to Week 52 | Study Terminated by Sponsor | 6 | 8 |
| Double Blind Period: Week 0 to Week 52 | Withdrawal by Subject | 1 | 1 |
| LTE Phase:Week 52 to 96(LTE Termination) | Protocol-specified withdrawal criterion met | 1 | 0 |
| LTE Phase:Week 52 to 96(LTE Termination) | Study Terminated by Sponsor | 3 | 0 |
| LTE Phase:Week 52 to 96(LTE Termination) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Guselkumab |
|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 11.69 | 37 years STANDARD_DEVIATION 10.86 | 35.3 years STANDARD_DEVIATION 10.07 |
| Age, Customized < 55 years | 15 Participants | 31 Participants | 16 Participants |
| Age, Customized >= 55 years | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 11 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 22 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 26 Participants | 14 Participants |
| Region of Enrollment ARGENTINA | 5 Participants | 9 Participants | 4 Participants |
| Region of Enrollment MEXICO | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment TAIWAN | 3 Participants | 3 Participants | 0 Participants |
| Region of Enrollment THAILAND | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment UKRAINE | 5 Participants | 12 Participants | 7 Participants |
| Region of Enrollment UNITED STATES | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 17 |
| other Total, other adverse events | 12 / 16 | 12 / 17 |
| serious Total, serious adverse events | 1 / 16 | 1 / 17 |
Outcome results
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.
Time frame: Week 24
Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24 | 56.3 percentage of participants |
| Guselkumab | Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24 | 35.3 percentage of participants |
Secondary
Change From Baseline in Chemistry Parameters: Protein/Creatinine
Change from baseline in chemistry parameter: protein/creatinine was reported.
Time frame: Baseline, Weeks 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameters: Protein/Creatinine | Week 24 | -1.509 mg/mg | Standard Deviation 1.9494 |
| Placebo | Change From Baseline in Chemistry Parameters: Protein/Creatinine | Week 52 | -1.586 mg/mg | Standard Deviation 1.7966 |
| Guselkumab | Change From Baseline in Chemistry Parameters: Protein/Creatinine | Week 24 | -0.821 mg/mg | Standard Deviation 2.425 |
| Guselkumab | Change From Baseline in Chemistry Parameters: Protein/Creatinine | Week 52 | -0.352 mg/mg | Standard Deviation 1.696 |
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.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time | Week 24 | 0.78 Seconds | Standard Deviation 1.734 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time | Week 52 | 0.88 Seconds | Standard Deviation 1.387 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Activated Partial Thromboplastin Time | Week 24 | 0.96 Seconds | Standard Deviation 3.869 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase
Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase | Week 24 | 2.6 Enzyme units per liter | Standard Deviation 10.98 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase | Week 52 | 2.3 Enzyme units per liter | Standard Deviation 4.92 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Alanine Aminotransferase | Week 24 | -3.1 Enzyme units per liter | Standard Deviation 6.57 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Albumin
Change from baseline in clinical laboratory parameter: albumin was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Albumin | Week 24 | 2.4 Grams per Liter (g/L) | Standard Deviation 5.57 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Albumin | Week 52 | 3.5 Grams per Liter (g/L) | Standard Deviation 5.32 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Albumin | Week 24 | 1.9 Grams per Liter (g/L) | Standard Deviation 4.58 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Albumin | Week 52 | -3.0 Grams per Liter (g/L) | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase
Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase | Week 24 | 1.9 Enzyme units per liter | Standard Deviation 16.75 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase | Week 52 | 6.5 Enzyme units per liter | Standard Deviation 5 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase | Week 24 | 1.7 Enzyme units per liter | Standard Deviation 8.07 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Alkaline Phosphatase | Week 52 | 6.0 Enzyme units per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase
Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase | Week 24 | 0.0 Enzyme units per liter | Standard Deviation 4.97 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase | Week 52 | 1.5 Enzyme units per liter | Standard Deviation 2.38 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase | Week 24 | -0.7 Enzyme units per liter | Standard Deviation 5.41 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Aspartate Aminotransferase | Week 52 | 1.0 Enzyme units per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Basophils
Change from baseline in clinical laboratory parameter: basophils was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Basophils | Week 24 | -0.009 10^9 cells per liter | Standard Deviation 0.0512 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Basophils | Week 52 | -0.070 10^9 cells per liter | Standard Deviation 0.099 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Basophils | Week 24 | -0.009 10^9 cells per liter | Standard Deviation 0.0502 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Bicarbonate
Change from baseline in clinical laboratory parameter: bicarbonate was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Bicarbonate | Week 24 | -0.78 mmol/L | Standard Deviation 4.97 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Bicarbonate | Week 52 | -2.20 mmol/L | Standard Deviation 2.38 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Bicarbonate | Week 24 | 0.21 mmol/L | Standard Deviation 5.41 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Bilirubin
Change from baseline in clinical laboratory parameter: bilirubin was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Bilirubin | Week 24 | 0.1 micromole per liter | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Bilirubin | Week 52 | -0.3 micromole per liter | Standard Deviation 2.06 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Bilirubin | Week 24 | 0.3 micromole per liter | Standard Deviation 2.46 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Bilirubin | Week 52 | 4.0 micromole per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Chloride
Change from baseline in clinical laboratory parameter: chloride was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Chloride | Week 24 | 0.1 mmol/L | Standard Deviation 4.5 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Chloride | Week 52 | 2.0 mmol/L | Standard Deviation 4.83 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Chloride | Week 52 | 2.0 mmol/L | — |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Chloride | Week 24 | 0.7 mmol/L | Standard Deviation 0.0958 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase
Change from baseline in clinical laboratory parameter: creatine kinase was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase | Week 24 | 3.3 Enzyme units per liter | Standard Deviation 42.22 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase | Week 52 | -8.8 Enzyme units per liter | Standard Deviation 36.65 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase | Week 24 | -0.5 Enzyme units per liter | Standard Deviation 53.94 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Creatine Kinase | Week 52 | -2.0 Enzyme units per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Creatinine
Change from baseline in clinical laboratory parameter: creatinine was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Creatinine | Week 24 | 0.6 micromole per liter | Standard Deviation 18.3 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Creatinine | Week 52 | -3.3 micromole per liter | Standard Deviation 7.54 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Creatinine | Week 24 | 6.7 micromole per liter | Standard Deviation 16.78 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Creatinine | Week 52 | -5.0 micromole per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Eosinophils
Change from baseline in clinical laboratory parameter: eosinophils was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Eosinophils | Week 24 | 0.022 10^9 cells per liter | Standard Deviation 0.0472 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Eosinophils | Week 52 | 0.000 10^9 cells per liter | Standard Deviation 0.0283 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Eosinophils | Week 24 | -0.041 10^9 cells per liter | Standard Deviation 0.162 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Erythrocytes
Change from baseline in clinical laboratory parameter: erythrocytes was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes | Week 24 | -0.16 10^12 cells per liter | Standard Deviation 0.582 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes | Week 52 | -0.40 10^12 cells per liter | Standard Deviation 0.566 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes | Week 24 | 0.12 10^12 cells per liter | Standard Deviation 0.577 |
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.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | 0.1 petagram (pg) | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 52 | -1.5 petagram (pg) | Standard Deviation 2.12 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Week 24 | -0.8 petagram (pg) | Standard Deviation 1.06 |
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.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume | Week 24 | 0.5 femtoliter (fL) | Standard Deviation 6.35 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume | Week 52 | -4.0 femtoliter (fL) | Standard Deviation 0 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Erythrocytes Mean Corpuscular Volume | Week 24 | -3.3 femtoliter (fL) | Standard Deviation 5.37 |
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.
Time frame: Baseline (Week 0), Weeks 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | Lactate dehydogenase: Week 52 | -62.5 Enzyme units per liter | Standard Deviation 40.31 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | gamma glutamyl transferase: Week 52 | 1.0 Enzyme units per liter | Standard Deviation 8.6 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | gamma glutamyl transferase: Week 24 | -0.6 Enzyme units per liter | Standard Deviation 15.01 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | Lactate dehydogenase: Week 24 | -14.5 Enzyme units per liter | Standard Deviation 47.9 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | Lactate dehydogenase: Week 52 | 7.0 Enzyme units per liter | — |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | Lactate dehydogenase: Week 24 | -2.5 Enzyme units per liter | Standard Deviation 17.52 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | gamma glutamyl transferase: Week 24 | -3.0 Enzyme units per liter | Standard Deviation 9.7 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Gamma Glutamyl and Transferase Lactate Dehydrogenase | gamma glutamyl transferase: Week 52 | -2.0 Enzyme units per liter | — |
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.
Time frame: Baseline (Week 0), Weeks 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Week 24 | 0.44 milliliter/minute/1.73 meter square | Standard Deviation 21.639 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Week 52 | 6.75 milliliter/minute/1.73 meter square | Standard Deviation 22.588 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Week 24 | -5.87 milliliter/minute/1.73 meter square | Standard Deviation 17.15 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Week 52 | 5.60 milliliter/minute/1.73 meter square | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium
Change from baseline in clinical laboratory parameter: glucose and magnesium were reported.
Time frame: Baseline, Weeks 24, 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Glucose: Week 24 | -0.23 millimoles per liter (mmol/L) | Standard Deviation 1.041 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Glucose:: Week 52 | -0.03 millimoles per liter (mmol/L) | Standard Deviation 0.126 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Magnesium: Week 24 | -0.024 millimoles per liter (mmol/L) | Standard Deviation 0.0696 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Magnesium: Week 52 | -0.068 millimoles per liter (mmol/L) | Standard Deviation 0.0842 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Magnesium: Week 52 | -0.010 millimoles per liter (mmol/L) | — |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Glucose: Week 24 | -0.04 millimoles per liter (mmol/L) | Standard Deviation 0.908 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Magnesium: Week 24 | -0.022 millimoles per liter (mmol/L) | Standard Deviation 0.0607 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Glucose and Magnesium | Glucose:: Week 52 | 0.20 millimoles per liter (mmol/L) | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Hematocrit
Change from baseline in clinical Laboratory parameter: hematocrit was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Hematocrit | Week 24 | -0.013 percentage of blood cells | Standard Deviation 0.0411 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Hematocrit | Week 52 | -0.055 percentage of blood cells | Standard Deviation 0.0495 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Hematocrit | Week 24 | -0.004 percentage of blood cells | Standard Deviation 0.0356 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils
Change from baseline in clinical laboratory parameter: segmented neutrophils was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils | Week 24 | -0.630 10^9 cells per liter | Standard Deviation 3.2494 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils | Week 52 | -3.990 10^9 cells per liter | Standard Deviation 5.8548 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Hematology Parameter: Segmented Neutrophils | Week 24 | -1.074 10^9 cells per liter | Standard Deviation 2.9652 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Hemoglobin
Change from baseline in clinical laboratory parameter: hemoglobin was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Hemoglobin | Week 24 | -5.2 grams per liter (g/L) | Standard Deviation 15.57 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Hemoglobin | Week 52 | -17.0 grams per liter (g/L) | Standard Deviation 22.63 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Hemoglobin | Week 24 | -0.3 grams per liter (g/L) | Standard Deviation 14.82 |
Secondary
Change From Baseline in Clinical Laboratory Parameter Leukocytes
Change from baseline in clinical laboratory parameter: leukocytes was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter Leukocytes | Week 52 | -5.120 10^9 cells per liter | Standard Deviation 7.7499 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter Leukocytes | Week 24 | -0.622 10^9 cells per liter | Standard Deviation 3.8729 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter Leukocytes | Week 24 | -1.157 10^9 cells per liter | Standard Deviation 3.1246 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Lymphocytes
Change from baseline in clinical laboratory parameter: lymphocytes was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Lymphocytes | Week 24 | 0.006 10^9 cells per Liter | Standard Deviation 0.5213 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Lymphocytes | Week 52 | -0.545 10^9 cells per Liter | Standard Deviation 1.096 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Lymphocytes | Week 24 | -0.032 10^9 cells per Liter | Standard Deviation 0.386 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Monocytes
Change from baseline in clinical laboratory parameter: monocytes was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Monocytes | Week 24 | -0.014 10^9 cells per liter | Standard Deviation 0.3277 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Monocytes | Week 52 | -0.510 10^9 cells per liter | Standard Deviation 0.7354 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Monocytes | Week 24 | -0.002 10^9 cells per liter | Standard Deviation 0.1268 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Phosphate
Change from baseline in clinical laboratory parameter: phosphate was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Phosphate | Week 24 | 0.060 mmol/L | Standard Deviation 0.1498 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Phosphate | Week 52 | -0.035 mmol/L | Standard Deviation 0.2213 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Phosphate | Week 24 | 0.030 mmol/L | Standard Deviation 0.2916 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Phosphate | Week 52 | 0.220 mmol/L | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Platelets
Change from baseline in clinical laboratory parameter: platelets was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Platelets | Week 24 | -36.7 10^9 cells per liter | Standard Deviation 61.43 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Platelets | Week 52 | -70.5 10^9 cells per liter | Standard Deviation 67.18 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Platelets | Week 24 | -17.8 10^9 cells per liter | Standard Deviation 61.89 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Protein
Change from baseline in clinical laboratory parameter: protein was reported.
Time frame: Baseline (Week 0), Weeks 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 24 | 3.0 gram per Liter (g/L) | Standard Deviation 8.83 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 52 | 7.0 gram per Liter (g/L) | Standard Deviation 7.39 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 24 | 2.9 gram per Liter (g/L) | Standard Deviation 6.55 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 52 | 1.0 gram per Liter (g/L) | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Protein
Change from baseline in clinical laboratory parameter: protein was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 24 | 3.0 g/L | Standard Deviation 8.83 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 52 | 7.0 g/L | Standard Deviation 7.39 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 24 | 2.9 g/L | Standard Deviation 16.78 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Protein | Week 52 | 1.0 g/L | — |
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.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio | Week 24 | 0.02 Ratio | Standard Deviation 0.09 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio | Week 52 | 0.00 Ratio | Standard Deviation 0 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Prothrombin International Normalized Ratio | Week 24 | 0.01 Ratio | Standard Deviation 0.064 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time
Change from baseline in clinical laboratory parameter: prothrombin time was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time | Week 24 | 0.18 second | Standard Deviation 0.766 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time | Week 52 | -0.03 second | Standard Deviation 0.359 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Prothrombin Time | Week 24 | 0.16 second | Standard Deviation 0.425 |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes
Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes | Week 24 | -0.0007 percentage of blood cells | Standard Deviation 0.00485 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes | Week 52 | 0.0000 percentage of blood cells | Standard Deviation 0.01414 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Reticulocytes/Erythrocytes | Week 24 | -0.0001 percentage of blood cells | Standard Deviation 0.00541 |
Secondary
Change From Baseline in Clinical Laboratory Parameters: Calcium
Change from baseline in clinical laboratory parameter: calcium was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Calcium | Week 24 | 0.039 mmol/L | Standard Deviation 0.1172 |
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Calcium | Week 52 | 0.000 mmol/L | Standard Deviation 0.1871 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Calcium | Week 24 | 0.073 mmol/L | Standard Deviation 0.0958 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Calcium | Week 52 | 0.010 mmol/L | — |
Secondary
Change From Baseline in Clinical Laboratory Parameters: Cholesterol
Change from baseline in clinical laboratory parameter: cholesterol was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Cholesterol | Week 24 | -1.325 mmol/L | Standard Deviation 1.3026 |
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Cholesterol | Week 52 | -2.235 mmol/L | Standard Deviation 1.6588 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Cholesterol | Week 24 | 0.017 mmol/L | Standard Deviation 0.7818 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Cholesterol | Week 52 | 0.210 mmol/L | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Sodium
Change from baseline in clinical laboratory parameter: sodium was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Sodium | Week 24 | -0.7 mmol/L | Standard Deviation 2.3 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Sodium | Week 52 | 1.0 mmol/L | Standard Deviation 1.41 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Sodium | Week 24 | 0.4 mmol/L | Standard Deviation 4.24 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Sodium | Week 52 | 3.0 mmol/L | — |
Secondary
Change From Baseline in Clinical Laboratory Parameters: Potassium
Change from baseline in clinical laboratory parameter: potassium was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Potassium | Week 24 | 0.19 mmol/L | Standard Deviation 0.704 |
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Potassium | Week 52 | 0.03 mmol/L | Standard Deviation 0.457 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Potassium | Week 24 | 0.13 mmol/L | Standard Deviation 0.402 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Potassium | Week 52 | 0.00 mmol/L | — |
Secondary
Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen
Change from baseline in clinical laboratory parameter: urea nitrogen was reported.
Time frame: Baseline (Week 0), Week 24, and Week 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen | Week 24 | -1.23 mmol/L | Standard Deviation 3.106 |
| Placebo | Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen | Week 52 | -1.60 mmol/L | Standard Deviation 1.564 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen | Week 24 | 0.71 mmol/L | Standard Deviation 2.177 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameters: Urea Nitrogen | Week 52 | 0.50 mmol/L | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Urate
Change from baseline in clinical laboratory parameter: urate was reported.
Time frame: Baseline, Weeks 24, 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Urate | Week 24 | -73.4 micromole per liter | Standard Deviation 104.11 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Urate | Week 52 | -79.5 micromole per liter | Standard Deviation 79.38 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Urate | Week 24 | 8.4 micromole per liter | Standard Deviation 48.61 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Urate | Week 52 | -2.0 micromole per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Urine Protein
Change from baseline in clinical laboratory parameter: urine protein was reported.
Time frame: Baseline (Week 0), Weeks 24 and 52
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Urine Protein | Week 24 | -1322.1 milligram per liter | Standard Deviation 1865.82 |
| Placebo | Change From Baseline in Clinical Laboratory Parameter: Urine Protein | Week 52 | -1821.7 milligram per liter | Standard Deviation 2334.78 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Urine Protein | Week 24 | -310.3 milligram per liter | Standard Deviation 1494.58 |
| Guselkumab | Change From Baseline in Clinical Laboratory Parameter: Urine Protein | Week 52 | -166.4 milligram per liter | Standard Deviation 1099.54 |
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) | 12 Participants |
| Guselkumab | Number of Participants With Adverse Events (AEs) | 12 Participants |
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With AEs Leading to Discontinuation of Study Intervention | 1 Participants |
| Guselkumab | Number of Participants With AEs Leading to Discontinuation of Study Intervention | 2 Participants |
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With AEs Temporally Associated With an Infusion | 1 Participants |
| Guselkumab | Number of Participants With AEs Temporally Associated With an Infusion | 0 Participants |
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With AEs With Injection-site Reactions | 1 Participants |
| Guselkumab | Number of Participants With AEs With Injection-site Reactions | 0 Participants |
Secondary
Number of Participants With Infections
Number of participants with infections as assessed by the investigator were reported.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Infections | 5 Participants |
| Guselkumab | Number of Participants With Infections | 6 Participants |
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 | Creatinine Increase | 0 Participants |
| Placebo | 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 | Hypokalemia | 0 Participants |
| Placebo | 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 | Alkaline Phosphatase Increased | 0 Participants |
| Placebo | 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 | Hypomagnesemia | 0 Participants |
| Placebo | 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 | GGT Increased | 0 Participants |
| Placebo | 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 | Hyponatremia | 0 Participants |
| Placebo | 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 | Blood Bilirubin Increased | 0 Participants |
| Placebo | 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 | Activated Partial Thromboplastin Time Prolonged | 0 Participants |
| Placebo | 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 | Hypermagnesemia | 0 Participants |
| Placebo | 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 | Anemia | 0 Participants |
| Placebo | 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 | CPK Increased | 0 Participants |
| Placebo | 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 | Hemoglobin Increased | 0 Participants |
| Placebo | 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 | Hypernatremia | 0 Participants |
| Placebo | 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 | Leukocytosis | 0 Participants |
| Placebo | 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 | Alanine Aminotransferase Increased | 0 Participants |
| Placebo | 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 | Lymphocyte Count Decreased | 0 Participants |
| Placebo | 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 | Hypertriglyceridemia | 0 Participants |
| Placebo | 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 | Lymphocyte Count Increased | 0 Participants |
| Placebo | 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 | Cholesterol High | 0 Participants |
| Placebo | 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 | Neutrophil Count Decreased | 0 Participants |
| Placebo | 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 | Hypoalbuminemia | 0 Participants |
| Placebo | 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 | Platelet Count Decreased | 0 Participants |
| Placebo | 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 | Aspartate Aminotransferase Increased | 0 Participants |
| Placebo | 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 | White Blood Cell Decreased | 0 Participants |
| Placebo | 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 | Hypoglycemia | 0 Participants |
| Guselkumab | 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 | White Blood Cell Decreased | 0 Participants |
| Guselkumab | 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 | Alanine Aminotransferase Increased | 0 Participants |
| Guselkumab | 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 | Alkaline Phosphatase Increased | 0 Participants |
| Guselkumab | 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 | Aspartate Aminotransferase Increased | 0 Participants |
| Guselkumab | 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 | CPK Increased | 0 Participants |
| Guselkumab | 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 | Cholesterol High | 0 Participants |
| Guselkumab | 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 | Creatinine Increase | 0 Participants |
| Guselkumab | 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 | GGT Increased | 0 Participants |
| Guselkumab | 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 | Hypermagnesemia | 0 Participants |
| Guselkumab | 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 | Hypernatremia | 0 Participants |
| Guselkumab | 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 | Hypertriglyceridemia | 0 Participants |
| Guselkumab | 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 | Hypoalbuminemia | 0 Participants |
| Guselkumab | 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 | Hypoglycemia | 0 Participants |
| Guselkumab | 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 | Hypokalemia | 0 Participants |
| Guselkumab | 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 | Hypomagnesemia | 0 Participants |
| Guselkumab | 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 | Hyponatremia | 0 Participants |
| Guselkumab | 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 | Activated Partial Thromboplastin Time Prolonged | 0 Participants |
| Guselkumab | 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 | Anemia | 0 Participants |
| Guselkumab | 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 | Hemoglobin Increased | 0 Participants |
| Guselkumab | 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 | Leukocytosis | 0 Participants |
| Guselkumab | 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 | Lymphocyte Count Decreased | 0 Participants |
| Guselkumab | 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 | Lymphocyte Count Increased | 0 Participants |
| Guselkumab | 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 | Neutrophil Count Decreased | 0 Participants |
| Guselkumab | 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 | Platelet Count Decreased | 0 Participants |
| Guselkumab | 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 | Blood Bilirubin Increased | 0 Participants |
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Related AEs | 2 Participants |
| Guselkumab | Number of Participants With Related AEs | 2 Participants |
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.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Guselkumab | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Participants With Serious Infections
Number of participants with serious infections as assessed by the investigator were reported.
Time frame: DB period: From Week 0 up to 12 week safety follow-up (i.e., up to Week 60); LTE phase: From Week 52 up to LTE phase termination (i.e., up to Week 96)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Serious Infections | 0 Participants |
| Guselkumab | Number of Participants With Serious Infections | 0 Participants |
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.
Time frame: From Baseline (Week 0) through Week 24 and Week 60
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-boosted Anti-drug Antibodies (ADA) Response | Week 24 | 1 Participants |
| Placebo | Number of Participants With Treatment-boosted Anti-drug Antibodies (ADA) Response | Week 60 | 1 Participants |
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.
Time frame: From Week 16 through Week 24
Population: FAS included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24 | 87.5 percentage of participants |
| Guselkumab | Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24 | 94.1 percentage of participants |
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.
Time frame: Week 52
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52 | 25.0 percentage of participants |
| Guselkumab | Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52 | 27.3 percentage of participants |
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).
Time frame: Week 24
Population: FAS included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24 | 18.8 percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24 | 17.6 percentage of participants |
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).
Time frame: Week 52
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved CRR at Week 52 | 25.0 percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved CRR at Week 52 | 9.1 percentage of participants |
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).
Time frame: Up to Week 24
Population: FAS included all randomized participants who received at least 1 dose of any study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved CRR Through Week 24 | 37.5 Percentage of participants |
| Guselkumab | Percentage of Participants Who Achieved CRR Through Week 24 | 23.5 Percentage of participants |
p-value: 0.780780% CI: [0.27, 1.41]log-rank test
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.
Time frame: Up to Week 60
Population: SAS included all participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Systolic Blood Pressure: <85 mmHg | 0 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Systolic Blood Pressure::>180 mmHg | 6.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure: <55 mmHg | 6.3 percentage of participants |
| Placebo | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure: >115 mmHg | 6.3 percentage of participants |
| Guselkumab | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure: >115 mmHg | 0 percentage of participants |
| Guselkumab | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Systolic Blood Pressure: <85 mmHg | 0 percentage of participants |
| Guselkumab | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure: <55 mmHg | 0 percentage of participants |
| Guselkumab | Percentage of Participants With Abnormal Vital Signs: Systolic and Diastolic Blood Pressure | Systolic Blood Pressure::>180 mmHg | 5.9 percentage of participants |
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).
Time frame: Up to Week 52
Population: FAS included all randomized participants who received at least 1 dose of any study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Treatment Failure (TF) Through Week 52 | 18.8 Percentage of participants |
| Guselkumab | Percentage of Participants With Treatment Failure (TF) Through Week 52 | 35.3 Percentage of participants |
p-value: 0.465480% CI: [0.62, 3.85]long-rank test
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.
Time frame: Week 24
Population: FAS included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With UPCR < 0.75 mg/mg at Week 24 | 37.5 percentage of participants |
| Guselkumab | Percentage of Participants With UPCR < 0.75 mg/mg at Week 24 | 35.3 percentage of participants |
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.
Time frame: Week 24
Population: FAS included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24 | 25.0 percentage of participants |
| Guselkumab | Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24 | 29.4 percentage of participants |
Secondary
Serum Concentration of Guselkumab
Serum Concentration of guselkumab were reported.
Time frame: Predose: Weeks 0,4,8,12,16,20,24, 36; Post-dose: Week 0 (1 hour after intravenous administration), Day 2, Week 52 and 60
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentration of Guselkumab | Week 12, predose | 18.17 microgram/milliliter | Standard Deviation 11.784 |
| Placebo | Serum Concentration of Guselkumab | Week 16, pre-dose | 9.89 microgram/milliliter | Standard Deviation 5.016 |
| Placebo | Serum Concentration of Guselkumab | Week 20, predose | 7.63 microgram/milliliter | Standard Deviation 4.689 |
| Placebo | Serum Concentration of Guselkumab | Week 24, predose | 6.42 microgram/milliliter | Standard Deviation 3.447 |
| Placebo | Serum Concentration of Guselkumab | Week 36, predose | 6.57 microgram/milliliter | Standard Deviation 1.827 |
| Placebo | Serum Concentration of Guselkumab | Week 0, predose | 0.00 microgram/milliliter | Standard Deviation 0 |
| Placebo | Serum Concentration of Guselkumab | Week 0, 1h after IV administration | 146.20 microgram/milliliter | Standard Deviation 41.273 |
| Placebo | Serum Concentration of Guselkumab | Day 2, post-dose | 96.55 microgram/milliliter | Standard Deviation 33.805 |
| Placebo | Serum Concentration of Guselkumab | Week 4, predose | 11.20 microgram/milliliter | Standard Deviation 7.175 |
| Placebo | Serum Concentration of Guselkumab | Week 8, predose | 12.85 microgram/milliliter | Standard Deviation 9.549 |
| Placebo | Serum Concentration of Guselkumab | Week 52, post-dose | 6.13 microgram/milliliter | Standard Deviation 3.262 |
| Placebo | Serum Concentration of Guselkumab | Week 60, post-dose | 0.39 microgram/milliliter | Standard Deviation 0.641 |