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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001734-34 | EudraCT Number |
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Sponsor decision
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This was a randomized, open-label, two arm, parallel group, proof-of-concept, nonconfirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with Idiopathic (primary) membranous nephropathy (iMN) who are at high risk of disease progression defined on the basis of anti- Phospholipase A2 Receptor (PLA2R) antibody titer ≥ 60 RU/mL and proteinuria with urine protein (UP) ≥ 3.5 g/24h.
The overall study was planned for a total of 65 weeks and included:
As per protocol amendment V01, subjects were randomized 1:1 to LNP023 (investigational drug) or Rituximab (comparator) and followed the below dosing schedule:
Initially, per protocol V00, subjects were planned to be randomized in a 1:1:1 ratio to 3 treatment arms:
Following protocol amendment 1 implementation, ongoing subjects were switched to 200mg b.i.d. dose after their initial 4 weeks of treatment.
3 subjects completed treatment under protocol V00. PK/PD data from the 3 completing subjects under protocol V00 are not included in the study results.
The main reason for protocol amendment V01 was to align with the clinical study results obtained from the interim analysis of ongoing phase 2 trials with LNP023 which had shown a dose dependent inhibition of the complement alternative pathway and support best efficacy results with LNP023 at a dose level of 200mg.
The study was early terminated as LNP023 after interim analysis of 12 LNP023 and 14 rituximab subjects because it could already be predicted at that point that the primary goal of superiority of LNP023 vs rituximab in the reduction of UPCR at 24 weeks was not possible to achieve if the study continued to completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNP023 | Experimental | As per protocol V00, participants took LNP023 10 mg orally b.i.d. for 4 weeks followed by LNP023 50 mg orally b.i.d. for 20 weeks. As per protocol amendment V01, participants took LNP023 50mg orally b.i.d. for 4 weeks followed by LNP023 200mg for 20 weeks. |
|
| Rituximab | Active Comparator | Rituximab 1 g i.v. at Day 1 and Day 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNP023 | Drug | Investigation of LNP023 |
| |
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | The primary endpoint of this study is the ratio between UPCR at 24 weeks of treatment measured in 24h urine and baseline UPCR . To assess the primary objective, the log-transformed ratio to baseline in UPCR was analyzed using a mixed model for repeated measures (MMRM). The results were back transformed and presented on the original scale. | Baseline, Day 113, Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | The drug (LNP023) is expected to block the complement alternative pathway dysregulation and thereby should normalize complement biomarker levels in serum. Bb is a biomarker that accurately reflects the level of complement Alternative Pathway activation. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | CABA | Buenos Aires | C1181ACH | Argentina | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| CLNP023D12201\_NovCTR\_\_28\_Dec\_2023.docx attachment has been refreshed from the Clinical Trials Results Word Form template. Data may be populated from the following (as available) : Study (123.0), Protocol (9.43), Results(1.6) | View source |
| A Plain Language Trial Summary is available on www.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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Participants took part in 18 investigative sites in 9 countries/regions: Argentina (3), Czech Republic (1), Germany (4), India (2), Netherlands (1), Spain (2), United Kingdom (3), China (1) and Taiwan (1)
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| ID | Title | Description |
|---|---|---|
| FG000 | LNP023 10/50 mg b.i.d. | As per protocol V00, participants took LNP023 10 mg orally b.i.d. for 4 weeks followed by LNP023 50 mg orally b.i.d. for 20 weeks |
| FG001 | LNP023 200 mg b.i.d. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 4, 2021 | Jan 17, 2024 |
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Open label study for treatment (LNP023 or rituximab).
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| Drug |
Comparison of rituximab dose |
|
| Baseline, Day 15, Day 29, Day 57, Day 113 and Day 169 |
| Change From Baseline in Plasma Levels of sC5b-9 | Soluble C5b-9 (sC5b-9) is a biomarker of the complement pathway activity that correlate with disease progression. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. | Baseline, Day 15, Day 29, Day 57, Day 113, Day 169 |
| Ratio to Baseline of Urine Protein Creatinine Ratio (UPCR) Measured in First Morning Void | Adjusted geometric mean ratio to baseline of Urine Protein Creatinine Ratio (UPCR) measured in first morning void. First morning void urine sample was collected in the morning of the day before the visit and kept in the fridge. | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266 and Day 378 |
| Number of Participants by Treatment Response at 24 Weeks of Treatment | Participants were considered complete responders if at 24 weeks of treatment, they showed complete remission of proteinuria (i.e., Urine Protein (UP) ≤ 0.3 g/24h), partial responders if they showed partial remission (i.e., UP > 0.3g/24h and ≤ 3.5 g/24h and a reduction of UP by >50% from baseline), and non-responders if UP >3.5g/24h and/or reduction of UP from baseline <50%. | Baseline, Day 169 |
| Change From Baseline in (eGFR) Estimated Glomerular Filtration Rate Over Time | Changes in renal function were assessed via estimated glomerular filtration rate (eGFR). Change in eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 |
| Pharmacokinetic Parameter Tmax in Plasma | Pharmacokinetics of LNP023 : Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (time). Actual sampling time points were considered for the calculation of PK parameters. | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
| Pharmacokinetic Parameter Cmax in Plasma | Pharmacokinetics of LNP023: Cmax is the maximum (peak) observed plasma drug concentration after dose administration (mass x volume-1) | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
| Pharmacokinetic Parameter AUClast in Plasma | Pharmacokinetics of LNP023: AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
| Pharmacokinetic Parameter AUCtau in Plasma | Pharmacokinetics of LNP023 : AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1) | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
| Pharmacokinetics in Urine: Renal Plasma Clearance Derived From 24 Hour Urine Sample | Pharmacokinetics of LNP023 in urine: Renal plasma clearance derived from 24 hour urine sample | Day 113 |
| Caba |
| Buenos Aires |
| C1280AEB |
| Argentina |
| Novartis Investigative Site | Córdoba | X5016KEH | Argentina |
| Novartis Investigative Site | Beijing | 100034 | China |
| Novartis Investigative Site | Prague | 12808 | Czechia |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Jena | 07740 | Germany |
| Novartis Investigative Site | Dehradun | Uttarakhand | 248001 | India |
| Novartis Investigative Site | New Delhi | 110029 | India |
| Novartis Investigative Site | Nijmegen | Netherland | 6525 GA | Netherlands |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46017 | Spain |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Leicester | LE5 4PW | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
Combination of the LNP023 25/200 mg b.i.d. and 50/200 mg b.i.d. groups. Under protocol V00, participants took LNP023 25 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks.
Under protocol v01, participants took LNP023 50 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks.
| FG002 | Rituximab | Rituximab 1 g i.v. at Day 1 and Day 15 |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LNP023 10/50 mg b.i.d. | As per protocol V00, participants took LNP023 10 mg orally b.i.d. for 4 weeks followed by LNP023 50 mg orally b.i.d. for 20 weeks |
| BG001 | LNP023 200 mg b.i.d. | Combination of the LNP023 25/200 mg b.i.d. and 50/200 mg b.i.d. groups. Under protocol V00, participants took LNP023 25 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. Under protocol v01, participants took LNP023 50 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. |
| BG002 | Rituximab | Rituximab 1 g i.v. at Day 1 and Day 15 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) | The primary endpoint of this study is the ratio between UPCR at 24 weeks of treatment measured in 24h urine and baseline UPCR . To assess the primary objective, the log-transformed ratio to baseline in UPCR was analyzed using a mixed model for repeated measures (MMRM). The results were back transformed and presented on the original scale. | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a value for UPCR at both Baseline and Day 113 or Day 169 were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | ratio to baseline | Baseline, Day 113, Day 169 |
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| Secondary | Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) | The drug (LNP023) is expected to block the complement alternative pathway dysregulation and thereby should normalize complement biomarker levels in serum. Bb is a biomarker that accurately reflects the level of complement Alternative Pathway activation. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with values of plasma levels of circulating fragment of factor B at both Baseline and the different time points were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Day 15, Day 29, Day 57, Day 113 and Day 169 |
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| Secondary | Change From Baseline in Plasma Levels of sC5b-9 | Soluble C5b-9 (sC5b-9) is a biomarker of the complement pathway activity that correlate with disease progression. Baseline is defined as the last non-missing measurement prior to randomization. Measurements for LNP023 group were done pre-dose. | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a value of plasma levels of sC5b-9 at both Baseline and the different time points were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Day 15, Day 29, Day 57, Day 113, Day 169 |
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| Secondary | Ratio to Baseline of Urine Protein Creatinine Ratio (UPCR) Measured in First Morning Void | Adjusted geometric mean ratio to baseline of Urine Protein Creatinine Ratio (UPCR) measured in first morning void. First morning void urine sample was collected in the morning of the day before the visit and kept in the fridge. | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a value of UPCR measured in first morning void at the different time points were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | ratio to baseline | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 266 and Day 378 |
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| Secondary | Number of Participants by Treatment Response at 24 Weeks of Treatment | Participants were considered complete responders if at 24 weeks of treatment, they showed complete remission of proteinuria (i.e., Urine Protein (UP) ≤ 0.3 g/24h), partial responders if they showed partial remission (i.e., UP > 0.3g/24h and ≤ 3.5 g/24h and a reduction of UP by >50% from baseline), and non-responders if UP >3.5g/24h and/or reduction of UP from baseline <50%. | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with UP values at both baseline and Day 169 were included in the analysis. | Posted | Count of Participants | Participants | Baseline, Day 169 |
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| Secondary | Change From Baseline in (eGFR) Estimated Glomerular Filtration Rate Over Time | Changes in renal function were assessed via estimated glomerular filtration rate (eGFR). Change in eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. | PD set: In line with the protocol, PD (pharmacodynamics) analyses were performed for all participants who received LNP023 200 mg or rituximab and experienced no protocol deviations with relevant impact on PD/efficacy data. Only participants with a eGFR value at both Baseline and the different time points were included in the analysis. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Baseline, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 |
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| Secondary | Pharmacokinetic Parameter Tmax in Plasma | Pharmacokinetics of LNP023 : Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (time). Actual sampling time points were considered for the calculation of PK parameters. | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | Posted | Median | Full Range | hours | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
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| Secondary | Pharmacokinetic Parameter Cmax in Plasma | Pharmacokinetics of LNP023: Cmax is the maximum (peak) observed plasma drug concentration after dose administration (mass x volume-1) | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
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| Secondary | Pharmacokinetic Parameter AUClast in Plasma | Pharmacokinetics of LNP023: AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
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| Secondary | Pharmacokinetic Parameter AUCtau in Plasma | Pharmacokinetics of LNP023 : AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1) | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at the different time points were included in the analysis. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) |
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| Secondary | Pharmacokinetics in Urine: Renal Plasma Clearance Derived From 24 Hour Urine Sample | Pharmacokinetics of LNP023 in urine: Renal plasma clearance derived from 24 hour urine sample | PK set: PK (pharmacokinetic) analysis set included all participants with at least one available valid PK concentration measurement, who received any LNP023 and experienced no protocol deviations with relevant impact on PK data. Only participants with PK values at Day 113 were included in the analysis. | Posted | Mean | Standard Deviation | L/hr | Day 113 |
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Adverse events were reported from first dose of study treatment until end of study treatment plus 29 weeks post treatment, up to maximum duration of 53 weeks.
The LNP023 200mg group is the sum of subjects from v00 (25/200mg, n=4) and v01 (50/200mg, n=15). A separation by subgroup was not justified as Part A doses were similar (25 vs 50mg), short-termed (4 weeks) and below levels expected to be efficacious, while the Part B dose of 200 mg was the same for all for up to 20 weeks. Moreover, if separated, the difference in subject numbers may have carried a risk of under- or over-interpretation of findings
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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 | LNP023 10/50 mg b.i.d. | As per protocol V00, participants took LNP023 10 mg orally b.i.d. for 4 weeks followed by LNP023 50 mg orally b.i.d. for 20 weeks | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | LNP023 200 mg b.i.d. | Combination of the LNP023 25/200 mg b.i.d. and 50/200 mg b.i.d. groups. Under protocol V00, participants took LNP023 25 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. Under protocol v01, participants took LNP023 50 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. | 0 | 19 | 3 | 19 | 13 | 19 |
| EG002 | Pooled LNP023 | Combination of the LNP023 10/50 mg b.i.d., 25/200 mg b.i.d. and 50/200 mg b.i.d. groups. | 0 | 22 | 3 | 22 | 15 | 22 |
| EG003 | Rituximab | Rituximab 1 g i.v. at Day 1 and Day 15 | 0 | 15 | 4 | 15 | 7 | 15 |
| EG004 | Total | Total | 0 | 37 | 7 | 37 | 22 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone hypertrophy | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Epididymal cyst | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
Per protocol, participants randomized to the former LNP023 low dose arm (LNP023 10/50 mg b.i.d.) were included in the safety and PK analyses but not in the PD/efficacy analyses as the low number of subjects would not have allowed for a meaningful analysis and interpretation of PD/efficacy data.
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 | Feb 22, 2023 | Jan 17, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Black Or African American |
|
| Unknown |
|
| White |
|
| Day 169 |
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| Participants |
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| OG003 | LNP023 50 mg b.i.d. (20-week Administration) | Under Protocol V00, LNP023 50mg taken orally b.i.d. during the last 20 weeks of treatment |
| OG004 | LNP023 200 mg b.i.d. | Under protocol V00, participants took LNP023 25 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. Under protocol v01, participants took LNP023 50 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. |
|
|
| LNP023 50 mg b.i.d. (20-week Administration) |
Under Protocol V00, LNP023 50mg taken orally b.i.d. during the last 20 weeks of treatment |
| OG004 | LNP023 200 mg b.i.d. | Under protocol V00, participants took LNP023 25 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. Under protocol v01, participants took LNP023 50 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. |
|
|
| OG003 |
| LNP023 50 mg b.i.d. (20-week Administration) |
Under Protocol V00, LNP023 50mg taken orally b.i.d. during the last 20 weeks of treatment |
| OG004 | LNP023 200 mg b.i.d. | Under protocol V00, participants took LNP023 25 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. Under protocol v01, participants took LNP023 50 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. |
|
|
| LNP023 50 mg b.i.d. (20-week Administration) |
Under Protocol V00, LNP023 50mg taken orally b.i.d. during the last 20 weeks of treatment |
| OG004 | LNP023 200 mg b.i.d. | Under protocol V00, participants took LNP023 25 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. Under protocol v01, participants took LNP023 50 mg orally b.i.d. for 4 weeks followed by LNP023 200 mg orally b.i.d. for 20 weeks. |
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