Lupus Nephritis, Immunoglobulin A Nephropathy, IgAN, LN
Conditions
Keywords
ALXN2050, Complement Factor D, Complement Alternative Pathway, LN, IgAN
Brief summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams \[mg\]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years. Safety will be monitored throughout the study.
Interventions
DRUGALXN2050
Oral tablets
DRUGPlacebo
Oral tablets
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking of treatment allocation will be observed at least until Week 50.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Both Cohorts * Participants on sodium-glucose cotransporter-2 (SGLT 2) inhibitors (eg, empagliflozin) must be on a stable dose for ≥ 3 months with no planned change in dose during the Blinded Treatment Periods (through Week 50). LN Cohort * Clinical diagnosis of SLE by 2019 American College of Rheumatology and European League Against Rheumatism criteria. * Diagnosis of 2018 Revised International Society of Nephrology/Renal Pathology Society classification (active focal or diffuse proliferative LN Class III or IV) confirmed by biopsy obtained ≤ 6 months prior to Screening or during Screening Period. Participants may co-exhibit Class V disease. Participants with de novo or relapsing disease may be eligible. * Clinically active LN at Screening requiring/receiving immunosuppression induction treatment in the opinion of the Investigator. * Proteinuria with UPCR ≥ 1 g/g based on one 24 hour urine collection during the Screening Period. IgAN Cohort * Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the Screening Period. * Mean proteinuria ≥ 1 g/day on 2 complete and valid 24 hour urine collections during the Screening Period. * For participants with a kidney biopsy performed \> 1 year prior to Screening that was used for eligibility: Presence of hematuria as defined by a positive result for blood on urine dipstick or ≥ 10 red blood cells (RBCs)/high power field (hpf) microscopy on urine sediment (documented by the local laboratory) during Screening Period. Presence of hematuria documented by the central laboratory may also be acceptable. * Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated ACE inhibitor and/or ARB dose for ≥ 3 months prior to Screening with no expected change in dose during the Blinded Treatment Periods (through Week 50) (participants with established intolerance to RAS inhibitors may be included). * Controlled and stable blood pressure (defined as \< 140/90 millimeters of mercury \[mmHg\]) over the past 3 months prior to randomization. Key
Exclusion criteria
Both Cohorts * eGFR ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration. * For participants with eGFR \< 45 mL/min/1.73 m2 at Screening, presence of any of the following in glomeruli on most recent kidney biopsy prior to or during the Screening Period: 1. ≥ 50% interstitial fibrosis and tubular atrophy 2. ≥ 50% glomerular sclerosis 3. ≥ 50% active crescent formation * Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period. * History of solid organ or bone marrow transplant, or planned transplant during the Blinded Extended Treatment Period (50 weeks). * Splenectomy or functional asplenia. * Known or suspected complement deficiency, unless attributable to underlying disease (that is, LN and IgAN). * Bone marrow insufficiency with absolute neutrophil count \< 1.3 × 10\^3/microliter; thrombocytopenia (platelet count \< 50,000/cubic millimeter). LN Cohort * Participants who have initiated any of the following treatments for the current active LN flare: 1. Cyclophosphamide ≤ 6 months prior to Screening 2. CNIs ≤ 1 months prior to Screening 3. A cumulative dose of intravenous (IV) methylprednisolone \> 3 g 4. Mycophenolate mofetil \> 2 g/day (or equivalent) for ≥ 8 consecutive weeks prior to Screening 5. Prednisone or prednisone equivalent ≥ 0.5 mg/kg/day for ≥ 8 consecutive weeks prior to Screening * Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 110 mmHg) on 2 or more measurements during the Screening Period. * Prior history or clinically active SLE-related cerebritis, seizures, stroke, or stroke syndrome requiring treatment or clinically active pericarditis * Inability to take or tolerate the standard of care background therapies IgAN Cohort * Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 30% over a period of 3 months prior to or during the Screening Period. * Secondary etiologies of IgAN. * Prednisone or prednisone equivalent \> 20 mg/day for \> 14 consecutive days or any other systemic immunosuppression for the treatment of IgAN ≤ 6 months prior to Screening * Blood pressure of ≥ 140/90 mmHg during the Screening Period confirmed on 2 measures \> 30 minutes apart.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | Baseline, Week 26 | Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26 and Week 50 | Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A reduction from baseline indicated an improvement in symptoms. |
| Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m\^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated an improvement in symptoms. |
| LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 26 and Week 50 | Complete renal response was defined as a decrease in urine protein to creatinine ratio (UPCR) to ≤0.5 gram/gram (g/g), an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal systemic lupus erythematosus (SLE) flare, or suboptimal response. |
| LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 26 and Week 50 | Partial renal response was defined as a decrease in UPCR ≥50% compared to baseline, an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response. |
| LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample | Up to Week 50 | UPCR was assessed using 24-hour urine collections obtained at designated time points. The time to the first occurrence of UPCR ≤0.5 g/g was summarized by spot urine sample analysis. |
| LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 12, Week 26, And Week 50 | A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator. |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | Baseline, Week 50 | Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms. |
| LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50 | Baseline Through Week 50 | Extrarenal SLE flare was defined as an increase in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Safety of Estrogens in Lupus Erythematosus National Assessment modification ≥4 points that was not accounted for by proteinuria, hematuria, urinary cellular casts, hypocomplementemia, or an increase in anti-double-stranded DNA antibody level. The SLEDAI-2K is an instrument that was used to assesses the disease activity of extrarenal SLE flare across 18 disease descriptors. Each descriptor carried a weighted value ranging from 1-8, with the reported score calculated as the sum of these descriptors and ranging from 0 to 85. Higher scores represent increased degrees of disease activity. |
| LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50 | Baseline through Week 50 | Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response. |
| LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | For the determination of serum albumin, blood samples were obtained at designated time points. Results reported as grams/liter (g/L). |
| LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50 | Baseline Through Week 50 | A suboptimal response was to be determined in the opinion of the investigator in addition to the following criterion: reproducible proteinuria ≤25% decreased compared to baseline based on UPCR on a 24-hour urine collection performed by a central laboratory. |
| IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 26 and Week 50 | Partial remission was defined as mean proteinuria \<1 g/24 hours, based on two valid 24-hour urine collections obtained within 2 weeks prior to the study visit. |
| LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50 | Baseline Through Week 50 | Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a complete renal response, a renal flare was the reproducible recurrence of proteinuria ≥1g/g. For all other participants, a renal flare was either of the following: a reproducible increase of serum creatinine \>25% higher than baseline or above the upper limit of normal (plus additional protocol-specified criteria) or a reproducible doubling of the UPCR from a 24-hour urine collection compared with the lowest previous value obtained after the first dose of study intervention. |
Countries
Argentina, Australia, Brazil, China, Germany, Israel, Italy, Mexico, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
For the immunoglobulin A nephropathy (IgAN) cohort, a total of 61 participants were enrolled in the study and randomized. For the lupus nephritis (LN) cohort, a total of 39 participants were enrolled in the study and randomized. Two doses of ALXN2050 were administered, 120 milligrams (mg) or 180 mg, both twice daily (bid).
Participants by arm
| Arm | Count |
|---|---|
| IgAN Cohort: ALXN2050 120 mg Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study. | 9 |
| IgAN Cohort: ALXN2050 180 mg Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study. | 26 |
| IgAN Cohort: Placebo Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. | 26 |
| LN Cohort: ALXN2050 120 mg Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study. | 6 |
| LN Cohort: ALXN2050 180 mg Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study. | 17 |
| LN Cohort: Placebo Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period. | 16 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Extended Treatment Period (24 Weeks) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Extended Treatment Period (24 Weeks) | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Extended Treatment Period (24 Weeks) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Extended Treatment Period (24 Weeks) | Pregnancy | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Extended Treatment Period (24 Weeks) | Study Terminated by Sponsor | 4 | 8 | 0 | 1 | 3 | 0 | 7 | 3 | 0 |
| Extended Treatment Period (24 Weeks) | Withdrawal by Subject | 0 | 3 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
| Initial Evaluation Period (26 Weeks) | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Initial Evaluation Period (26 Weeks) | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Initial Evaluation Period (26 Weeks) | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Initial Evaluation Period (26 Weeks) | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 3 | 0 |
| Initial Evaluation Period (26 Weeks) | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 0 |
| Open-label Extension Period (2 Years) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Open-label Extension Period (2 Years) | Study Terminated by Sponsor | 4 | 12 | 0 | 8 | 5 | 2 | 5 | 0 | 6 |
| Open-label Extension Period (2 Years) | Withdrawal by Subject | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | IgAN Cohort: ALXN2050 120 mg | IgAN Cohort: ALXN2050 180 mg | IgAN Cohort: Placebo | LN Cohort: ALXN2050 120 mg | LN Cohort: ALXN2050 180 mg | LN Cohort: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 18 - 65 years | 9 Participants | 24 Participants | 25 Participants | 6 Participants | 17 Participants | 16 Participants | 97 Participants |
| Age, Customized >65 years | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 5 Participants | 2 Participants | 9 Participants | 7 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 20 Participants | 21 Participants | 4 Participants | 8 Participants | 9 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) White | 7 Participants | 20 Participants | 20 Participants | 3 Participants | 9 Participants | 6 Participants | 65 Participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 10 Participants | 6 Participants | 12 Participants | 13 Participants | 53 Participants |
| Sex: Female, Male Male | 6 Participants | 17 Participants | 16 Participants | 0 Participants | 5 Participants | 3 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 26 | 0 / 26 | 0 / 13 | 0 / 13 | 0 / 6 | 1 / 17 | 1 / 16 | 0 / 6 |
| other Total, other adverse events | 7 / 9 | 17 / 26 | 19 / 26 | 4 / 10 | 7 / 9 | 5 / 6 | 13 / 17 | 13 / 16 | 1 / 6 |
| serious Total, serious adverse events | 0 / 9 | 2 / 26 | 2 / 26 | 1 / 10 | 1 / 9 | 1 / 6 | 5 / 17 | 2 / 16 | 0 / 6 |
Outcome results
Primary
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Time frame: Baseline, Week 26
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | -29.3 Percentage Change |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | -26.2 Percentage Change |
| IgAN Cohort: Placebo | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | -10.3 Percentage Change |
| LN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | -84.0 Percentage Change |
| LN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | -58.0 Percentage Change |
| LN Cohort: Placebo | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | -55.4 Percentage Change |
p-value: 0.242290% CI: [-37.5, 8.3]ANCOVA
p-value: 0.870190% CI: [-49.3, 74.4]ANCOVA
Secondary
Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m\^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated an improvement in symptoms.
Time frame: Baseline, Week 26 and Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 26 | -2.29 mL/min/1.73 m^2 | Standard Error 2.625 |
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 50 | -5.97 mL/min/1.73 m^2 | Standard Error 4.458 |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 26 | -0.47 mL/min/1.73 m^2 | Standard Error 1.564 |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 50 | -6.03 mL/min/1.73 m^2 | Standard Error 2.52 |
| IgAN Cohort: Placebo | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 26 | -1.62 mL/min/1.73 m^2 | Standard Error 2.248 |
| IgAN Cohort: Placebo | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 50 | -3.36 mL/min/1.73 m^2 | Standard Error 3.587 |
| LN Cohort: ALXN2050 120 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 26 | -0.73 mL/min/1.73 m^2 | Standard Error 2.323 |
| LN Cohort: ALXN2050 120 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 50 | -0.80 mL/min/1.73 m^2 | Standard Error 4.007 |
| LN Cohort: ALXN2050 180 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 26 | 11.92 mL/min/1.73 m^2 | Standard Error 12.77 |
| LN Cohort: ALXN2050 180 mg | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 50 | 2.58 mL/min/1.73 m^2 | Standard Error 13.94 |
| LN Cohort: Placebo | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 26 | -3.76 mL/min/1.73 m^2 | Standard Error 5.59 |
| LN Cohort: Placebo | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 50 | -5.65 mL/min/1.73 m^2 | Standard Error 7.45 |
| LN Cohort: Placebo | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 26 | 8.84 mL/min/1.73 m^2 | Standard Error 5.78 |
| LN Cohort: Placebo | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Week 50 | 5.07 mL/min/1.73 m^2 | Standard Error 7.28 |
Secondary
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Time frame: Baseline, Week 50
Population: Full Analysis Set: all participants who have been randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | -22.0 Percentage Change |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | -30.2 Percentage Change |
| IgAN Cohort: Placebo | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | -45.9 Percentage Change |
| LN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | -14.0 Percentage Change |
| LN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | -80.7 Percentage Change |
| LN Cohort: Placebo | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | -68.6 Percentage Change |
| LN Cohort: Placebo | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | -74.4 Percentage Change |
Secondary
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A reduction from baseline indicated an improvement in symptoms.
Time frame: Week 26 and Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >30% Reduction | 40.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >50% Reduction | 11.1 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >50% Reduction | 0.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >30% Reduction | 55.6 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >30% Reduction | 50.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >30% Reduction | 34.6 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >50% Reduction | 15.4 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >50% Reduction | 28.6 Percentage of Participants |
| IgAN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >50% Reduction | 8.0 Percentage of Participants |
| IgAN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >30% Reduction | 16.0 Percentage of Participants |
| LN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >30% Reduction | 77.8 Percentage of Participants |
| LN Cohort: ALXN2050 120 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >50% Reduction | 55.6 Percentage of Participants |
| LN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >30% Reduction | 22.2 Percentage of Participants |
| LN Cohort: ALXN2050 180 mg | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >50% Reduction | 0.0 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >30% Reduction | 50.0 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >50% Reduction | 50.0 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >50% Reduction | 25.0 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >30% Reduction | 25.0 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >50% Reduction | 50.0 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >50% Reduction | 35.7 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >30% Reduction | 42.9 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >30% Reduction | 50.0 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >50% Reduction | 57.1 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 50: >30% Reduction | 71.4 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >30% Reduction | 54.5 Percentage of Participants |
| LN Cohort: Placebo | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26: >50% Reduction | 45.5 Percentage of Participants |
Secondary
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50
Partial remission was defined as mean proteinuria \<1 g/24 hours, based on two valid 24-hour urine collections obtained within 2 weeks prior to the study visit.
Time frame: Week 26 and Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 50 | 0.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 26 | 22.2 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 50 | 35.7 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 26 | 23.1 Percentage of Participants |
| IgAN Cohort: Placebo | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 26 | 16.0 Percentage of Participants |
| LN Cohort: ALXN2050 120 mg | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 50 | 55.6 Percentage of Participants |
| LN Cohort: ALXN2050 180 mg | IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50 | Week 50 | 22.2 Percentage of Participants |
Secondary
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50
For the determination of serum albumin, blood samples were obtained at designated time points. Results reported as grams/liter (g/L).
Time frame: Baseline, Week 26 and Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Week 26 | 11.0 g/L | — |
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Week 50 | 3.5 g/L | Standard Deviation 4.95 |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Week 26 | 1.5 g/L | Standard Deviation 5.98 |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Week 50 | 0.1 g/L | Standard Deviation 5.87 |
| IgAN Cohort: Placebo | LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Week 50 | 1.0 g/L | Standard Deviation 2.83 |
| IgAN Cohort: Placebo | LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50 | Week 26 | 4.1 g/L | Standard Deviation 5.7 |
Secondary
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50
A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator.
Time frame: Week 12, Week 26, And Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 50 | 100 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 12 | 100 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 26 | 100 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 50 | 83.3 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 26 | 84.6 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 12 | 100 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 50 | 100 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 26 | 90.9 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 12 | 78.6 Percentage of Participants |
Secondary
LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50
Extrarenal SLE flare was defined as an increase in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Safety of Estrogens in Lupus Erythematosus National Assessment modification ≥4 points that was not accounted for by proteinuria, hematuria, urinary cellular casts, hypocomplementemia, or an increase in anti-double-stranded DNA antibody level. The SLEDAI-2K is an instrument that was used to assesses the disease activity of extrarenal SLE flare across 18 disease descriptors. Each descriptor carried a weighted value ranging from 1-8, with the reported score calculated as the sum of these descriptors and ranging from 0 to 85. Higher scores represent increased degrees of disease activity.
Time frame: Baseline Through Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50 | 0.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50 | 0.0 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50 | 18.8 Percentage of Participants |
Secondary
LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50
Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a complete renal response, a renal flare was the reproducible recurrence of proteinuria ≥1g/g. For all other participants, a renal flare was either of the following: a reproducible increase of serum creatinine \>25% higher than baseline or above the upper limit of normal (plus additional protocol-specified criteria) or a reproducible doubling of the UPCR from a 24-hour urine collection compared with the lowest previous value obtained after the first dose of study intervention.
Time frame: Baseline Through Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50 | 0.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50 | 5.9 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50 | 6.3 Percentage of Participants |
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50
Complete renal response was defined as a decrease in urine protein to creatinine ratio (UPCR) to ≤0.5 gram/gram (g/g), an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal systemic lupus erythematosus (SLE) flare, or suboptimal response.
Time frame: Week 26 and Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 26 | 25.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 50 | 0.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 26 | 14.3 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 50 | 22.2 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 26 | 9.1 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 50 | 42.9 Percentage of Participants |
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50
Partial renal response was defined as a decrease in UPCR ≥50% compared to baseline, an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Time frame: Week 26 and Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 26 | 25.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 50 | 0.01 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 26 | 14.3 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 50 | 0.01 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 26 | 45.5 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 50 | 28.6 Percentage of Participants |
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50
A suboptimal response was to be determined in the opinion of the investigator in addition to the following criterion: reproducible proteinuria ≤25% decreased compared to baseline based on UPCR on a 24-hour urine collection performed by a central laboratory.
Time frame: Baseline Through Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50 | 16.7 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50 | 35.3 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50 | 18.8 Percentage of Participants |
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50
Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Time frame: Baseline through Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50 | 0.0 Percentage of Participants |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50 | 5.9 Percentage of Participants |
| IgAN Cohort: Placebo | LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50 | 12.5 Percentage of Participants |
Secondary
LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample
UPCR was assessed using 24-hour urine collections obtained at designated time points. The time to the first occurrence of UPCR ≤0.5 g/g was summarized by spot urine sample analysis.
Time frame: Up to Week 50
Population: Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IgAN Cohort: ALXN2050 120 mg | LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample | 2.4 Weeks |
| IgAN Cohort: ALXN2050 180 mg | LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample | NA Weeks |
| IgAN Cohort: Placebo | LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample | 12.1 Weeks |