A Phase 2 interventional study of LNP023 and Placebo in IgA Nephropathy, sponsored by Novartis Pharmaceuticals. Completed at 56 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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Among 18 studies in Glomerulonephritis, IGA by Novartis — 9 open to participants now, 12 under way, 7 of them phase 3. Glomerulonephritis, IGA · Novartis.
Among the 18 studies in Glomerulonephritis, IGA by Novartis, this one is the 7th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2018, is one of 5 in phase 2, and was the 1st registered.
276 studies on the registry are indexed under Glomerulonephritis, IGA; 108 are open to participants now.
Browse Glomerulonephritis, IGA studies →9 of the 18 studies in Glomerulonephritis, IGA by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, China, Colombia and 5 more countries
Ages 2–18
Novartis Pharmaceuticals · Sites in United States, Brazil, China and 8 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Argentina, Australia and 5 more countries
Ages 2–18
Novartis Pharmaceuticals · Sites in United States, Argentina, Australia and 6 more countries
Ages 18–100
Novartis Pharmaceuticals · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 68 Glomerulonephritis, IGA studies recruiting now, 39 (57%) set no upper age limit and 24 (35%) stop at 75 or younger; 21 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 8
First in 2018; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 112 is above the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Median enrollment 108 across the 14 interventional studies, 300 across the 3 observational. Of the 5 that completed or were terminated, 3 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
2 of the studies in Glomerulonephritis, IGA by Novartis that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05852938Phase 3Novartis PharmaceuticalsA Study of Zigakibart in Adults With IgA Nephropathy | 2027-08-10 |
| NCT06797518Novartis PharmaceuticalsStudy to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN | 2027-11-27 |
Add all 2 to your calendar (.ics) → With an account.
Among the 18 studies in Glomerulonephritis, IGA by Novartis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Efficacy and safety of LNP023 in IgAN patients
This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study with an adaptive design (Part 1 informed the design adaptations for Part 2). In Part 1, three doses of LNP023 (10 mg, 50 mg, and 200 mg) vs. placebo control were compared; In Part 2, four doses of LNP023 (10 mg, 50 mg, 100 mg, and 200 mg) vs. placebo control were compared. The study comprised a run-in phase in order that patients were on stable and maximally tolerated dose of Angiotensin-converting-enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for at least 90 days, a 90 days treatment phase in Part 1; a 180 days treatment phase in Part 2 and a 90 days follow-up phase in both Parts 1 and 2.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
History of immunodeficiency diseases, or a positive (ELISA and Western blot) test result.
Chronic infection with (HBV) or (HCV). A positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a patient. Patients with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject's medical history and/or clinical or laboratory evidence of any of the following:
A history of abnormalities, or any of the following ECG abnormalities at screening or baseline:
Women of , defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of during dosing and for 1 week after stopping of investigational drug. Highly effective contraception methods include:
If local regulations deviate from the contraception methods listed above and require more extensive measures to prevent pregnancy, local regulations apply and will be described in the ICF.
Women are considered and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo identical to LNP023 twice a day
Other: Placebo
10 mg taken twice a day.
Drug: LNP023
50 mg taken twice a day.
Drug: LNP023
100 mg taken twice a day.
Drug: LNP023
200 mg taken twice a day.
Drug: LNP023
LNP023 5, 25, 100 mg capsles
Matching placebo to LNP023
MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90
The primary analysis of the dose-response effect of LNP023 versus placebo on the reduction in UPCR 24 hours at Day 90 was done using Multiple Comparison Procedure Modelling (MCP-Mod). The existence of a dose-response relationship was assessed at the MCP step at the one-sided 10% significance level vis a multiple contrasts test. In the Mod step, the mean predicted difference between each LNP023 dose and placebo were then estimated using parametric bootstrap model averaging. Results are presented on the original scale as geometric mean ratios. A ratio less than 1 indicates a reduction in proteinuria. Participants collected all urine over a 24 hour period for UPCR test.
Time frame: Baseline and Day 90
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90
eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). The CKD-EPI equation is an established, widely used and Kidney Disease Improving Global Outcomes (KDIGO) guideline recommended method of GFR estimation based on serum creatinine, age, gender and race of the patient. It was derived and validated established from a meta-analyses of multiple studies including large number of patients.
Time frame: Baseline and Day 90
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Serum Creatinine - Parts 1 and 2 at Day 90
Serum creatinine
Time frame: Baseline and Day 90
Shift Table From Baseline for Hematuria Levels - Parts 1 and 2 at Day 90
Hematuria levels were the number of erythrocytes/high-power-field (hpf) measured through microscopic examination. The table shows the shift in hematuria grade (Low: \<9 rbc/hpf, Intermediate: \>=9 to \<= 50 rbc/hpf, High: \>50 rbc/hpf) from baseline (rows) to Day 90 (columns). A lower grade corresponds to a better outcome. Only patients with both baseline and Day 90 hematuria values are presented. L=low, I=intermediate and H=high in column headings for doses and BL=baseline
Time frame: Baseline and Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24hour Urine Protein (UP) - Parts 1 and 2 to Day 90
Participants collected all of their urine over a 24-hour period.
Time frame: Baseline and Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline of 24 Hour Urine Albumin (UA) - Parts 1 and 2 to Day 90
Participants collected all of their urine over a 24-hour period.
Time frame: Baseline and Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Parts 1 and 2 to Day 90
Participants collected all of their urine over a 24-hour period.
Time frame: Baseline and Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in Urine Protein to Creatinine (UPCR) From 1st Morning Void - Parts 1 and 2 at Day 90
A midstream urine sample was obtained from the first morning void (FMV) on the visit day.
Time frame: Baseline and Day 90
Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) at Day 30
AUClast,ss: the area under the plasma concentration-time curve from time zero to last quantifiable concentration at steady state AUCtau,ss: the area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state
Time frame: Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs)
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) and Maximum Concentrations (Cmax,ss) at Day 30
Cmax,ss: the observed maximum plasma concentration following drug administration at steady state (ng/mL) Ctrough,ss: the pre-dose plasma concentration observed during a dosing interval at steady state (ng/mL)
Time frame: Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs)
Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) at Day 30
Tmax,ss: the time to reach the maximum concentration after drug administration at steady state (h)
Time frame: Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs)
Amount of LNP023 Excreted Into Urine (Ae,ss) at Day 30
Ae,ss: the total cumulative urinary excretion at steady state
Time frame: Baseline and Day 30
Percent of LNP023 Excreted Into Urine at Day 30
Percent of drug excreted into the urine
Time frame: Baseline and Day 30
Renal Clearance From Plasma at Steady State (CLr,ss) at Day 30
The renal clearance from plasma at steady state
Time frame: Baseline and Day 30
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90
The complement AP biomarkers Bb and sC5b-9 were evaluated as potential pharmacodynamics and mode-of-action markers. Both biomarkers were measured using validated enzyme-linked immunosorbent assays (ELISAs).
Time frame: Baseline, Days 8, 15, 30, 60, 90
Estimation of the Lowest Dose Providing Maximal Reduction of Proteinuria as Measured by the Ratio to Baseline in UPCR at Day 90
The table shows the ratio to baseline in UPCR at Day 90 by treatment group. The lowest dose providing maximal reduction of proteinuria is the dose with the smallest UPCR ratio to baseline estimate (i.e. LNP023 200mg),
Time frame: Baseline up to Month 3
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Part 2 up to Day 180
eGFR; estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Time frame: Baseline and Day 180
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline Protein to Creatinine (UPCR) From 1st Morning Void - Part 2 up to Day 180
A midstream urine sample was obtained from the first morning void (FMV) on the visit day.
Time frame: Baseline and Day 180
Shift Table From Baseline for Hematuria Levels - Part 2 at Day 180
Hematuria levels were the number of erythrocytes/high-power-field (hpf) measured through microscopic examination. The table shows the shift in hematuria grade (Low: \<9 rbc/hpf, Intermediate: \>=9 to \<= 50 rbc/hpf, High: \>50 rbc/hpf) from baseline (rows) to Day 180 (columns). A lower grade corresponds to a better outcome. Only patients with both baseline and Day 90 hematuria values are presented. L=low, I=intermediate and H=high in column headings for doses and BL=baseline
Time frame: Baseline and Day 180
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline in Protein Level Urine Using the Urine Protein-creatinine Ratio (UPCR) From 24 Hour Urine Collection - Part 2 up to Day 180
For UPCR test, participants collected all of their urine over a 24-hour period
Time frame: Baseline, Days 30, 90 and 180
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Part 2 up to Day 180
The 24-hour urine collection was started 1 day prior to the clinic visit, after participant urinated for the first time, than all urine was collected for the next 24 hours and refrigerated prior to clinic visit.
Time frame: Baseline and Day 180
| Milestone | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Started | 9 | 8 | 0 | 15 | 14 |
| Completed | 9 | 8 | 0 | 15 | 14 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Started | 11 | 11 | 22 | 11 | 11 |
| Completed | 11 | 10 | 22 | 11 | 10 |
| Not completed | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 1 |
The primary analysis of the dose-response effect of LNP023 versus placebo on the reduction in UPCR 24 hours at Day 90 was done using Multiple Comparison Procedure Modelling (MCP-Mod). The existence of a dose-response relationship was assessed at the MCP step at the one-sided 10% significance level vis a multiple contrasts test. In the Mod step, the mean predicted difference between each LNP023 dose and placebo were then estimated using parametric bootstrap model averaging. Results are presented on the original scale as geometric mean ratios. A ratio less than 1 indicates a reduction in proteinuria. Participants collected all urine over a 24 hour period for UPCR test.
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 | 0.85 (0.77 to 0.93) | 0.80 (0.73 to 0.87) | 0.76 (0.70 to 0.81) | 0.69 (0.61 to 0.77) | 0.88 (0.80 to 1.00) |
eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). The CKD-EPI equation is an established, widely used and Kidney Disease Improving Global Outcomes (KDIGO) guideline recommended method of GFR estimation based on serum creatinine, age, gender and race of the patient. It was derived and validated established from a meta-analyses of multiple studies including large number of patients.
| mL/min/SSA | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90 | -0.06 ± 1.760 | 2.49 ± 1.859 | 0.23 ± 1.821 | 2.42 ± 1.545 | -3.34 ± 1.606 |
Serum creatinine
| umol/L | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Serum Creatinine - Parts 1 and 2 at Day 90 | -2.55 ± 3.488 | -2.60 ± 3.665 | 0.76 ± 3.555 | -3.47 ± 3.043 | 6.65 ± 3.150 |
Hematuria levels were the number of erythrocytes/high-power-field (hpf) measured through microscopic examination. The table shows the shift in hematuria grade (Low: \<9 rbc/hpf, Intermediate: \>=9 to \<= 50 rbc/hpf, High: \>50 rbc/hpf) from baseline (rows) to Day 90 (columns). A lower grade corresponds to a better outcome. Only patients with both baseline and Day 90 hematuria values are presented. L=low, I=intermediate and H=high in column headings for doses and BL=baseline
| participants | 10mg-L | 10mg-I | 10mg-H | 50mg-L | 50mg-I | 50mg-H | 100mg-L | 100mg-I | 100mg-H | 200mg-L | 200mg-I | 200mg-H | Pl-L | PL-I | PL-H |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Low at baseline | 7 | 1 | — | 13 | 0 | — | 6 | 0 | — | 6 | 0 | — | 6 | 2 | 0 |
| Intermediate at baseline | 1 | 3 | — | 1 | 1 | — | 4 | 0 | — | 6 | 2 | — | 4 | 0 | 1 |
| High at baseline | 0 | 0 | — | 0 | 0 | — | 2 | 1 | — | 0 | 0 | — | 0 | 0 | 0 |
Participants collected all of their urine over a 24-hour period.
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24hour Urine Protein (UP) - Parts 1 and 2 to Day 90 | 0.80 (0.661 to 0.965) | 0.89 (0.740 to 1.070) | 0.61 (0.509 to 0.729) | 0.70 (0.601 to 0.823) | 0.84 (0.713 to 0.987) |
Participants collected all of their urine over a 24-hour period.
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline of 24 Hour Urine Albumin (UA) - Parts 1 and 2 to Day 90 | 0.79 (0.648 to 0.964) | 0.93 (0.763 to 1.122) | 0.61 (0.504 to 0.734) | 0.73 (0.623 to 0.865) | 0.82 (0.693 to 0.973) |
Participants collected all of their urine over a 24-hour period.
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Parts 1 and 2 to Day 90 | 0.85 (0.728 to 0.998) | 0.89 (0.765 to 1.045) | 0.66 (0.567 to 0.772) | 0.74 (0.647 to 0.842) | 0.87 (0.756 to 0.998) |
A midstream urine sample was obtained from the first morning void (FMV) on the visit day.
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in Urine Protein to Creatinine (UPCR) From 1st Morning Void - Parts 1 and 2 at Day 90 | 0.76 (0.638 to 0.908) | 0.81 (0.674 to 0.970) | 0.61 (0.509 to 0.725) | 0.70 (0.598 to 0.815) | 0.83 (0.704 to 0.970) |
AUClast,ss: the area under the plasma concentration-time curve from time zero to last quantifiable concentration at steady state AUCtau,ss: the area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state
| hr*ng/mL | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID |
|---|---|---|---|---|
| AUClast,ss | 5820 ± 1750 | 13000 ± 2740 | 18400 ± 6040 | 27900 ± 9930 |
| AUCtau,ss | 8010 ± 2550 | 17700 ± 4250 | 24700 ± 8030 | 37100 ± 13500 |
Cmax,ss: the observed maximum plasma concentration following drug administration at steady state (ng/mL) Ctrough,ss: the pre-dose plasma concentration observed during a dosing interval at steady state (ng/mL)
| ng/mL | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID |
|---|---|---|---|---|
| Ctrough,ss | 515 ± 232 | 1130 ± 348 | 1510 ± 567 | 2200 ± 964 |
| Cmax,ss | 964 ± 264 | 2150 ± 480 | 3300 ± 1080 | 4940 ± 1770 |
Tmax,ss: the time to reach the maximum concentration after drug administration at steady state (h)
| hour | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID |
|---|---|---|---|---|
| Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) at Day 30 | 2.00 (0.250 to 6.00) | 2.00 (1.00 to 6.00) | 2.00 (0.500 to 6.00) | 2.00 (0.500 to 4.00) |
Ae,ss: the total cumulative urinary excretion at steady state
| mg | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID |
|---|---|---|---|---|
| Amount of LNP023 Excreted Into Urine (Ae,ss) at Day 30 | 1.72 ± 1.15 | 11.7 ± 5.84 | 30.9 ± 17.0 | 60.3 ± 27.1 |
Percent of drug excreted into the urine
| percent of dose | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID |
|---|---|---|---|---|
| Percent of LNP023 Excreted Into Urine at Day 30 | 8.59 ± 5.77 | 11.7 ± 5.84 | 15.5 ± 8.50 | 15.1 ± 6.77 |
The renal clearance from plasma at steady state
| L/hr | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID |
|---|---|---|---|---|
| Renal Clearance From Plasma at Steady State (CLr,ss) at Day 30 | 0.112 ± 0.0744 | 0.348 ± 0.179 | 0.719 ± 0.479 | 0.942 ± 0.540 |
The complement AP biomarkers Bb and sC5b-9 were evaluated as potential pharmacodynamics and mode-of-action markers. Both biomarkers were measured using validated enzyme-linked immunosorbent assays (ELISAs).
| ng/mL | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Day 8 - Bb, n=14,16,13,25,19 | 76.7 ± 22.89 | 72.2 ± 22.86 | 71.4 ± 30.66 | 66.3 ± 28.15 | 102.7 ± 19.78 |
| Day 15 - Bb, n=13,14,16,22,22 | 80.4 ± 32.59 | 74.1 ± 23.30 | 78.5 ± 33.35 | 72.9 ± 20.47 | 108.6 ± 23.19 |
| Day 30 - Bb, n=16,17,18,26,24 | 76.4 ± 18.32 | 76.2 ± 23.62 | 76.8 ± 34.00 | 70.4 ± 28.96 | 99.3 ± 22.07 |
| Day 60 - Bb, n=14,16,17,25,21 | 78.8 ± 20.26 | 75.2 ± 19.05 | 77.4 ± 35.23 | 72.8 ± 23.97 | 102.9 ± 24.07 |
| Day 90 - Bb, n=17,16,17,25,21 | 90.5 ± 25.57 | 79.3 ± 22.47 | 77.6 ± 35.42 | 74.6 ± 23.91 | 102.7 ± 22.01 |
| Day 8 sC5B-9, n=12,16,13,22,17 | 80.6 ± 12.29 | 69.6 ± 37.40 | 65.9 ± 24.05 | 75.8 ± 30.15 | 95.2 ± 22.01 |
| Day 15 sC5B-9, n=13,14,16,21,21 | 79.4 ± 27.60 | 72.2 ± 33.86 | 78.4 ± 33.35 | 78.0 ± 32.06 | 99.4 ± 25.40 |
| Day 30 sC5B-9, n=16,17,18,25,24 | 85.8 ± 23.88 | 68.6 ± 41.32 | 76.4 ± 25.97 | 69.8 ± 21.98 | 94.2 ± 24.96 |
| Day 60 sC5B-9, n=14,16,17,24,20 | 84.6 ± 27.37 | 73.7 ± 31.99 | 74.9 ± 29.65 | 76.2 ± 29.80 | 95.7 ± 30.11 |
| Day 90 sC5B-9, n=16,16,17,23,19 | 89.6 ± 28.66 | 73.8 ± 36.21 | 79.0 ± 22.82 | 75.0 ± 34.21 | 103.4 ± 21.52 |
The table shows the ratio to baseline in UPCR at Day 90 by treatment group. The lowest dose providing maximal reduction of proteinuria is the dose with the smallest UPCR ratio to baseline estimate (i.e. LNP023 200mg),
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Estimation of the Lowest Dose Providing Maximal Reduction of Proteinuria as Measured by the Ratio to Baseline in UPCR at Day 90 | 0.85 (0.77 to 0.93) | 0.80 (0.73 to 0.87) | 0.76 (0.70 to 0.81) | 0.69 (0.61 to 0.77) | 0.88 (0.80 to 1.00) |
eGFR; estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
| mL/min/SSA | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Part 2 up to Day 180 | 0.78 ± 1.977 | -2.35 ± 1.995 | -2.91 ± 1.359 | -1.18 ± 1.798 | -3.17 ± 1.868 |
A midstream urine sample was obtained from the first morning void (FMV) on the visit day.
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline Protein to Creatinine (UPCR) From 1st Morning Void - Part 2 up to Day 180 | 0.81 (0.599 to 1.108) | 0.72 (0.534 to 0.976) | 0.63 (0.507 to 0.784) | 0.72 (0.544 to 0.949) | 0.79 (0.590 to 1.047) |
Hematuria levels were the number of erythrocytes/high-power-field (hpf) measured through microscopic examination. The table shows the shift in hematuria grade (Low: \<9 rbc/hpf, Intermediate: \>=9 to \<= 50 rbc/hpf, High: \>50 rbc/hpf) from baseline (rows) to Day 180 (columns). A lower grade corresponds to a better outcome. Only patients with both baseline and Day 90 hematuria values are presented. L=low, I=intermediate and H=high in column headings for doses and BL=baseline
| participants | 10mg-L | 10mg-I | 10mg-H | 50mg-L | 50mg-I | 50mg-H | 100mg-L | 100mg-I | 100mg-H | 200mg-L | 200mg-I | 200mg-H | Pl-L | PL-I | PL-H |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Low at baseline | 1 | 1 | — | 5 | — | — | 2 | 0 | — | 4 | — | — | 4 | — | 0 |
| Intermediate at baseline | 2 | 1 | — | 1 | — | — | 3 | 0 | — | 2 | — | — | 0 | — | 1 |
| High at baseline | 0 | 0 | — | 0 | — | — | 2 | 1 | — | 0 | — | — | 0 | — | 0 |
For UPCR test, participants collected all of their urine over a 24-hour period
| mg/d | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Change From Baseline in Protein Level Urine Using the Urine Protein-creatinine Ratio (UPCR) From 24 Hour Urine Collection - Part 2 up to Day 180 | 1.06 (0.803 to 1.394) | 0.59 (0.452 to 0.779) | 0.66 (0.540 to 0.798) | 0.73 (0.568 to 0.940) | 0.91 (0.705 to 1.185) |
The 24-hour urine collection was started 1 day prior to the clinic visit, after participant urinated for the first time, than all urine was collected for the next 24 hours and refrigerated prior to clinic visit.
| Ratio to baseline | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo |
|---|---|---|---|---|---|
| Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Part 2 up to Day 180 | 1.04 (0.779 to 1.392) | 0.61 (0.454 to 0.808) | 0.65 (0.526 to 0.792) | 0.69 (0.533 to 0.902) | 0.91 (0.696 to 1.200) |
Collected over Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.. Non-serious events are listed at a 1.8% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LNP023 10mg On-treatment | 0/20 (0%) | 0/20 (0%) | 14/20 (70%) |
| LNP023 50mg On-treatment | 0/19 (0%) | 1/19 (5.3%) | 16/19 (84.2%) |
| LNP023 100mg On-treatment | 0/22 (0%) | 0/22 (0%) | 15/22 (68.2%) |
| LNP023 200mg On-treatment | 0/26 (0%) | 0/26 (0%) | 14/26 (53.8%) |
| Placebo On-treatment | 0/25 (0%) | 1/25 (4%) | 17/25 (68%) |
| LNP023 10mg Follow-up | 0/20 (0%) | 1/20 (5%) | 6/20 (30%) |
| LNP023 50mg Follow-up | 0/19 (0%) | 1/19 (5.3%) | 5/19 (26.3%) |
| LNP023 100mg Follow-up | 0/22 (0%) | 2/22 (9.1%) | 5/22 (22.7%) |
| LNP023 200mg Follow-up | 0/26 (0%) | 1/26 (3.8%) | 10/26 (38.5%) |
| Placebo Follow-up | 0/25 (0%) | 1/25 (4%) | 7/25 (28%) |
| Event | LNP023 10mg On-treatment | LNP023 50mg On-treatment | LNP023 100mg On-treatment | LNP023 200mg On-treatment | Placebo On-treatment | LNP023 10mg Follow-up | LNP023 50mg Follow-up | LNP023 100mg Follow-up | LNP023 200mg Follow-up | Placebo Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|
| COVID-19Infections and infestations | 0/20 | 1/19 | 0/22 | 0/26 | 0/25 | 0/20 | 1/19 | 0/22 | 0/26 | 0/25 |
| InfluenzaInfections and infestations | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 | 1/20 | 0/19 | 0/22 | 0/26 | 0/25 |
| AppendicitisInfections and infestations | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 | 0/20 | 0/19 | 1/22 | 0/26 | 0/25 |
| Renal impairmentRenal and urinary disorders | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 | 0/20 | 0/19 | 1/22 | 1/26 | 0/25 |
| Polycythaemia veraNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 | 0/20 | 0/19 | 0/22 | 0/26 | 1/25 |
| AspirationRespiratory, thoracic and mediastinal disorders | 0/20 | 0/19 | 0/22 | 0/26 | 1/25 | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 |
| Event | LNP023 10mg On-treatment | LNP023 50mg On-treatment | LNP023 100mg On-treatment | LNP023 200mg On-treatment | Placebo On-treatment | LNP023 10mg Follow-up | LNP023 50mg Follow-up | LNP023 100mg Follow-up | LNP023 200mg Follow-up | Placebo Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 2/20 | 2/19 | 2/22 | 2/26 | 6/25 | 0/20 | 0/19 | 1/22 | 0/26 | 0/25 |
| Abdominal discomfortGastrointestinal disorders | 0/20 | 3/19 | 2/22 | 0/26 | 0/25 | 0/20 | 1/19 | 0/22 | 0/26 | 1/25 |
| DizzinessNervous system disorders | 2/20 | 3/19 | 1/22 | 0/26 | 0/25 | 1/20 | 0/19 | 1/22 | 0/26 | 1/25 |
| NauseaGastrointestinal disorders | 3/20 | 1/19 | 0/22 | 0/26 | 1/25 | 0/20 | 0/19 | 1/22 | 0/26 | 1/25 |
| VomitingGastrointestinal disorders | 3/20 | 2/19 | 0/22 | 1/26 | 1/25 | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 |
| HypotensionVascular disorders | 3/20 | 0/19 | 0/22 | 2/26 | 0/25 | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 |
| Back painMusculoskeletal and connective tissue disorders | 1/20 | 0/19 | 3/22 | 1/26 | 3/25 | 1/20 | 0/19 | 0/22 | 1/26 | 0/25 |
| DiarrhoeaGastrointestinal disorders | 0/20 | 2/19 | 1/22 | 1/26 | 3/25 | 1/20 | 0/19 | 0/22 | 0/26 | 0/25 |
| FatigueGeneral disorders | 0/20 | 2/19 | 1/22 | 0/26 | 3/25 | 0/20 | 0/19 | 0/22 | 1/26 | 0/25 |
| PyrexiaGeneral disorders | 0/20 | 2/19 | 1/22 | 1/26 | 0/25 | 0/20 | 0/19 | 0/22 | 0/26 | 0/25 |
| Age, Continuous(years) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 39.2 ± 12.42 | 36.6 ± 8.42 | 36.0 ± 13.15 | 42.5 ± 15.76 | 39.4 ± 11.00 | 38.9 ± 12.58 |
| Age, Customized(Participants) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| 18 years - <65 years | 20 | 19 | 21 | 24 | 25 | 109 |
| 65 years - <85 years | 0 | 0 | 1 | 2 | 0 | 3 |
| Sex: Female, Male(Participants) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 11 | 6 | 11 | 11 | 7 | 46 |
| Male | 9 | 13 | 11 | 15 | 18 | 66 |
| Race/Ethnicity, Customized(Participants) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Asian | 10 | 9 | 12 | 12 | 11 | 54 |
| White | 10 | 9 | 10 | 13 | 13 | 55 |
| Black or African American | 0 | 1 | 0 | 1 | 0 | 2 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 1 |
| Urine Protein to Creatinine Ratio (UPCR)(g/mol) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 214.1 ± 122.29 | 188.2 ± 90.38 | 203.4 ± 98.29 | 151.0 ± 109.46 | 146.6 ± 61.62 | 177.9 ± 100.02 |
| Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m^2) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 66.0 ± 28.51 | 53.8 ± 22.73 | 67.0 ± 31.75 | 57.9 ± 28.92 | 65.7 ± 32.60 | 62.2 ± 29.30 |
| Supine Blood Pressure(mmHg) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Systolic | 134.4 ± 11.65 | 122.6 ± 12.15 | 125.0 ± 11.30 | 125.7 ± 11.66 | 125.5 ± 11.37 | 126.5 ± 11.89 |
| Diastolic | 84.1 ± 7.65 | 76.9 ± 8.41 | 80.0 ± 10.40 | 79.7 ± 7.62 | 78.2 ± 7.32 | 79.6 ± 8.26 |
| Prior use of ACEi and/or ARB(Participants) | LNP023 10 mg BID | LNP023 50 mg BID | LNP023 100 mg BID - Part 2 | LNP023 200 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Count of participants | 19 | 19 | 22 | 26 | 25 | 111 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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
Ran from Feb 2018 to primary completion in Dec 2020, 34 months.
Results were first posted in Oct 2022, 1 year 9 months after primary completion. A results delay was requested in Jul 2021.
Of 41 phase 2 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's 34 months is close to that.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iptacopan