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This study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus nephritis.
This was a randomized, subject and investigator blind, placebo controlled multicenter study with multiple doses of CFZ533 administered by 1-hour intravenous infusion over a 24 week treatment period, as compared to matched placebo infusion. The treatment period was followed by a 24-week safety follow-up period.The duration of the study (including the screening period) for each patient was approximately 53 weeks. The investigational drug or placebo was administered on top of standard of care therapy for lupus nephritis.
Patients were screened within 29 days of the first study drug infusion. Eligibility was confirmed at the baseline visit within one week before the first dose. Eligible patients were assigned a randomization number and receive the intravenous infusion within 3 days of baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CFZ533 | Experimental | Investigational drug CFZ533 will be administred as multiple doses |
|
| Placebo | Placebo Comparator | Investigational drug matching placebo will be administered as multiple doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CFZ533 | Drug | Multiple doses of 10 mg/kg CFZ533 intravenous (IV) infusion. CFZ533 was administered every 4 weeks (Q4W; from Day 1 to Day 141), plus an additional dose of 10 mg/kg IV at Day 15, resulting in a Q2W loading regimen up to the third dose on Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation. | Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks. |
| Ratio to Baseline in Urinary Protein Creatinine Ratio (UPCR) | A urine protein creatinine ratio (UPCR) test is a urine test. It measures the levels of protein and creatinine in urine. UPCR was assessed using the first morning void if available at a visit otherwise using the clinic spot sample, and was expressed as protein/creatinine (mg/mmol). High UPCR values can be a sign of kidney disease. An UPCR ratio to baseline <1 indicates improvement from baseline. | Baseline, Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) | A urine protein creatinine ratio (UPCR) test is a urine test. It measures the levels of protein and creatinine in urine. UPCR was assessed using the first morning void if available at a visit otherwise using the clinic spot sample, and was expressed as protein/creatinine (mg/mmol). High UPCR values can be a sign of kidney disease. An UPCR ratio to baseline <1 indicates improvement from baseline. |
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Key Inclusion Criteria:
Men and women with systemic lupus erythematosus (SLE) aged ≥ 18 years and ≤ 75 years at screening, fulfilling at least 4 out of 11 criteria for SLE as defined by the American College of Rheumatology (Tan at al 1982, revised by Hochberg 1997)
Subjects must have a body mass index (BMI) within the range of 18 - 40 kg/m2 at screening visit
Histological diagnosis of proliferative lupus nephritis World Health Organization (WHO) ISN/RPS (Weening et al 2004) Class III or IV within 5 years of screening
Presence of antinuclear autoantibody (ANA titer ≥ 1:80) at screening
Morning UPCR ≥ 0.5 at screening visit and baseline visit
At least one of the following:
Patient must have sufficient kidney function as estimated by eGFR ˃ 30mL/min/1.73 m2 at screening and baseline visits (Levey et al 2009)
Patient must have active disease as defined by proteinuria and additional symptoms as above despite standard of care therapy for LN as considered appropriate by the treating physician (e.g., corticosteroids and/or immunosuppressive or immunomodulatory treatments such as mycophenolate, azathioprine, methotrexate or hydroxychloroquine). For guidance, see published guidelines such as Bertsias et all 2012 and Hahn et al 2012.
Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must use highly effective methods of contraception during dosing and until study completion.
Key Exclusion Criteria:
Any glomerulonephritis other than WHO Class III or IV lupus nephritis. Patients with proliferative nephritis (Class III or IV) who, in addition, have overlapping histological signs for other glomerulonephritis, e.g., Class V, are eligible at the investigator´s discretion.
Hypoalbuminemia (serum albumin of less than 2.0 g/dL)
Patients who have received:
Patients who are at significant risk for the thromboembolic events based on the following:
Have had signs or symptoms of a clinically significant systemic viral, bacterial or fungal infection within 30 days prior to randomization
Live vaccines within 4 weeks of the first study drug infusion
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ciudad Autonoma de Bs As | Buenos Aires | C1015ABO | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40813108 | Derived | Shen N, Weinmann-Menke J, Malvar A, Serra-Roma A, Weiss M, Danekula R, Sips C, Rohr J, Felten R, Gergely P, Shisha T. Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: a randomised, double-blind, placebo-controlled, phase II study. RMD Open. 2025 Aug 14;11(3):e005557. doi: 10.1136/rmdopen-2025-005557. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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There was a screening period within 29 days to assess participants eligibility. After last dose of study treatment patients could enter the post-treatment follow-up.
Participants took part in 21 investigative sites in 10 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | CFZ533 10 mg/kg i.v. | CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141 |
| FG001 | Placebo i.v. | Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Epoch |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2021 | Jun 13, 2024 |
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| Placebo | Drug | multiple doses of placebo intravenous infusion |
|
| Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 (End of Study) |
| Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of CFZ533 | Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of free CFZ533. | Day 141: pre dose and 1 hour post dose |
| Pre-dose Trough Concentration (Ctrough) of CFZ533 | Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Ctrough is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval. | Pre-dose at: Day 1, Day 15, Day 29, Day 57, Day 85, Day 113 and Day 141 |
| The Observed Maximum Plasma Concentration Following CFZ533 Administration at Steady State (Cmax,ss) | Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Cmax,ss is the observed maximum plasma concentration following CFZ533 administration at steady state [mass/volume]. | Day 141: pre dose and 1 hour post dose |
| Total Soluble CD40 Plasma Concentrations | Total soluble CD40 concentrations in plasma. An increase in soluble CD40 concentrations is considered a marker for CFZ533 target engagement. This endpoint is only applicable to the CFZ533 arm. | Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of Study) |
| Number of Participants With Anti-CFZ533 Antibodies | To evaluate the immunogenicity of CFZ533 via the quasi-quantitative analysis of anti-CFZ533 antibodies. | Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of study) |
| Hematuria Casts- Urine White Blood Cell Casts | Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Hematuria is the presence of blood in the urine. Hematuria casts were assessed by microscopic urinalysis and classified as granular casts and WBC casts. Only in the event of a positive result, these samples were submitted to reflex testing microscopic analysis for counting of casts which resulted in a numeric value related to the number of respective casts presented in the urine. | Baseline, Day 1 (Pre dose), and Day 309 |
| Hematuria Casts- Casts Granular | Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Hematuria is the presence of blood in the urine. Hematuria casts were assessed by microscopic urinalysis and classified as granular casts and WBC casts. Only in the event of a positive result, these samples were submitted to reflex testing microscopic analysis for counting of casts which resulted in a numeric value related to the number of respective casts presented in the urine. | Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 253, and Day 337 (end of study) |
| Change From Baseline in Urine Hyaline Casts | Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Urine hyaline casts were assessed by microscopic urinalysis. | Baseline, Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 57 (Pre dose), Day 85 (Pre dose), Day 113 (Pre dose), Day 141 (Pre dose), Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 and Day 337 (end of study) |
| Number of Participants Who Fulfil the Criteria for Complete Renal Remission (CRR) | The criteria for CRR were defined as:
If the UPCR from the first morning void sample was not available, then the UPCR from the corresponding spot sample taken at the investigator site was used in the derivation of complete renal remission. | Baseline, up to Day 169 |
| Córdoba |
| X5016KEH |
| Argentina |
| Novartis Investigative Site | Guangzhou | Guangdong | 510000 | China |
| Novartis Investigative Site | Changsha | Hunan | 410008 | China |
| Novartis Investigative Site | Ürümqi | Xinjiang | 830001 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Shanghai | 200127 | China |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Rostov-on-Don | 344022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197110 | Russia |
| Novartis Investigative Site | Yaroslavl | 150062 | Russia |
| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Taichung | 40705 | Taiwan |
| Novartis Investigative Site | Taipei | 10048 | Taiwan |
| Novartis Investigative Site | Tunis | 1008 | Tunisia |
| Novartis Investigative Site | Kocaeli | 41380 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post-Treatment Follow-up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CFZ533 10 mg/kg i.v. | CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141 |
| BG001 | Placebo i.v. | Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation. | The safety analysis set included all participants who received any study drug. | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Ratio to Baseline in Urinary Protein Creatinine Ratio (UPCR) | A urine protein creatinine ratio (UPCR) test is a urine test. It measures the levels of protein and creatinine in urine. UPCR was assessed using the first morning void if available at a visit otherwise using the clinic spot sample, and was expressed as protein/creatinine (mg/mmol). High UPCR values can be a sign of kidney disease. An UPCR ratio to baseline <1 indicates improvement from baseline. | Participants in the pharmacodynamics (PD) analysis set with an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Geometric Mean | 95% Confidence Interval | ratio to baseline in UPCR | Baseline, Day 169 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Ratio to Baseline for Urine Protein Creatinine Ratio (UPCR) | A urine protein creatinine ratio (UPCR) test is a urine test. It measures the levels of protein and creatinine in urine. UPCR was assessed using the first morning void if available at a visit otherwise using the clinic spot sample, and was expressed as protein/creatinine (mg/mmol). High UPCR values can be a sign of kidney disease. An UPCR ratio to baseline <1 indicates improvement from baseline. | Participants in the pharmacodynamics (PD) analysis set with an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | ratio to baseline in UPCR | Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 (End of Study) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of CFZ533 | Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of free CFZ533. | Participants in the Pharmacokinetic (PK) analysis set with an available value for the outcome measure. The (PK) analysis set included all subjects with at least one available valid PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. The PK analysis set is only applicable to the CFZ533 arm. | Posted | Mean | Standard Deviation | day*ug/mL | Day 141: pre dose and 1 hour post dose |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pre-dose Trough Concentration (Ctrough) of CFZ533 | Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Ctrough is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval. | Participants in the Pharmacokinetic (PK) analysis set with an available value for the outcome measure. The (PK) analysis set included all subjects with at least one available valid PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. The PK analysis set is only applicable to the CFZ533 arm. | Posted | Mean | Standard Deviation | ug/mL | Pre-dose at: Day 1, Day 15, Day 29, Day 57, Day 85, Day 113 and Day 141 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Observed Maximum Plasma Concentration Following CFZ533 Administration at Steady State (Cmax,ss) | Pharmacokinetic parameters were directly derived from the PK concentration data using non-compartmental analysis. Cmax,ss is the observed maximum plasma concentration following CFZ533 administration at steady state [mass/volume]. | Participants in the Pharmacokinetic (PK) analysis set with an available value for the outcome measure. The PK analysis set included all subjects with at least one available valid PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. The PK analysis set is only applicable to the CFZ533 arm. | Posted | Mean | Standard Deviation | ug/mL | Day 141: pre dose and 1 hour post dose |
|
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| Secondary | Total Soluble CD40 Plasma Concentrations | Total soluble CD40 concentrations in plasma. An increase in soluble CD40 concentrations is considered a marker for CFZ533 target engagement. This endpoint is only applicable to the CFZ533 arm. | Participants in the Pharmacodynamics (PD) analysis set who received CFZ533 and had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of Study) |
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| Secondary | Number of Participants With Anti-CFZ533 Antibodies | To evaluate the immunogenicity of CFZ533 via the quasi-quantitative analysis of anti-CFZ533 antibodies. | Participants in the Pharmacodynamics (PD) analysis set who received CFZ533 and had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Number | Participants | Day 1, Day 15, Day 29, Day 57, Day 113, Day 169, Day 225, Day 281, Day 337 (End of study) |
|
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| Secondary | Hematuria Casts- Urine White Blood Cell Casts | Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Hematuria is the presence of blood in the urine. Hematuria casts were assessed by microscopic urinalysis and classified as granular casts and WBC casts. Only in the event of a positive result, these samples were submitted to reflex testing microscopic analysis for counting of casts which resulted in a numeric value related to the number of respective casts presented in the urine. | Participants in the pharmacodynamics (PD) analysis set with a microscopic urinalysis and an available value for the outcome measure at baseline and the corresponding time point. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | number of casts per low power field | Baseline, Day 1 (Pre dose), and Day 309 |
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| Secondary | Hematuria Casts- Casts Granular | Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Hematuria is the presence of blood in the urine. Hematuria casts were assessed by microscopic urinalysis and classified as granular casts and WBC casts. Only in the event of a positive result, these samples were submitted to reflex testing microscopic analysis for counting of casts which resulted in a numeric value related to the number of respective casts presented in the urine. | Participants in the pharmacodynamics (PD) analysis set with a microscopic urinalysis and an available value for the outcome measure at baseline and the corresponding time point. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | number of casts per low power field | Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 253, and Day 337 (end of study) |
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| Secondary | Change From Baseline in Urine Hyaline Casts | Urine was tested using a dipstick. If the dipstick result was positive for protein, nitrite, leucocytes and/or blood, a microscopic analysis of white blood cells (WBC), red blood cells (RBC) and casts was performed. Urine hyaline casts were assessed by microscopic urinalysis. | Participants in the pharmacodynamics (PD) analysis set with a microscopic urinalysis and an available value for the outcome measure at baseline and the corresponding time point. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. The participants analyzed are the ones with available value for the outcome measure at baseline and the corresponding time point. | Posted | Mean | Standard Deviation | number of casts per low power field | Baseline, Day 1 (Pre dose), Day 15 (Pre dose), Day 29 (Pre dose), Day 57 (Pre dose), Day 85 (Pre dose), Day 113 (Pre dose), Day 141 (Pre dose), Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 and Day 337 (end of study) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Fulfil the Criteria for Complete Renal Remission (CRR) | The criteria for CRR were defined as:
If the UPCR from the first morning void sample was not available, then the UPCR from the corresponding spot sample taken at the investigator site was used in the derivation of complete renal remission. | Participants in the pharmacodynamics (PD) analysis set with an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Count of Participants | Participants | Baseline, up to Day 169 |
|
|
Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 49 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CCFZ533 10mg/kg | CFZ533 10 mg/kg i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141 | 2 | 39 | 6 | 39 | 32 | 39 |
| EG001 | Placebo i.v. | Placebo i.v. dose on Day 1, 15, 29, 57, 85, 113, and 141 | 0 | 18 | 3 | 18 | 18 | 18 |
| EG002 | All Patients | All patients | 2 | 57 | 9 | 57 | 50 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eyelid bleeding | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Peri-implantitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Skin wound | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood immunoglobulin M decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Systemic lupus erythematosus disease activity index abnormal | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Urine protein/creatinine ratio increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Occipital neuralgia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2023 | Jun 13, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626035 | iscalimab |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| AEs leading to discontinuation of study treatment |
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| SAEs leading to discontinuation of study treatment |
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