Study of Ravulizumab in Proliferative Lupus Nephritis (LN... | NCT04564339

ID	Type	Description	Link
2020-001537-13	EudraCT Number

Label	Type	Description	Intervention Names
Ravulizumab: LN Cohort	Experimental	Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.	Drug: Ravulizumab Other: Background Therapy
Placebo: LN Cohort	Placebo Comparator	Eligible participants will receive placebo IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.	Drug: Placebo Other: Background Therapy
Ravulizumab: IgAN Cohort	Experimental	Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.	Drug: Ravulizumab Other: Background Therapy
Placebo: IgAN Cohort	Placebo Comparator	Eligible participants will receive placebo IV infusion in combination with background therapy during the Initial Evaluation Period (26 weeks) and will switch to ravulizumab for the Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.

Name	Type	Description	Arm Group Labels	Other Names
Ravulizumab	Drug	Dosages (loading and maintenance) will be based on the participant's body weight.	Placebo: IgAN Cohort Ravulizumab: IgAN Cohort Ravulizumab: LN Cohort

Measure	Description	Time Frame
IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections)	Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms.	Baseline, Week 26
LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections)	Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms.	Baseline, Week 26

Measure	Description	Time Frame
IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections)	Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms.	Baseline, Week 50

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		San Dimas	California	91773	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
39455063	Derived	Lafayette R, Tumlin J, Fenoglio R, Kaufeld J, Perez Valdivia MA, Wu MS, Susan Huang SH, Alamartine E, Kim SG, Yee M, Kateifides A, Rice K, Garlo K, Barratt J; SANCTUARY Study Investigators. Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Apr 1;36(4):645-656. doi: 10.1681/ASN.0000000534. Epub 2024 Oct 25.
37528520

Label	URL
Related Info	View source

ID	Title	Description
FG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab intravenous (IV) infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then every 8 weeks (q8w) thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 26, 2024	Jan 6, 2026

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections)

Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms.

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Geometric Least Squares Mean

95% Confidence Interval

percentage change

Baseline, Week 26

ID	Title	Description
OG000	IgAN Cohort: Ravulizumab	Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
OG001	IgAN Cohort: Placebo	Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).

Units	Counts
Participants	OG00041 OG00122

Title

Denominators

Categories

Title	Measurements
	OG000-41.9(-50.2 to -32.0) OG001-16.8(-31.8 to 1.6)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0053		Percentage Difference	-30.1			2-Sided	90	-43.5	-13.7					Superiority

Primary

LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections)

Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms.

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Geometric Least Squares Mean

95% Confidence Interval

percentage change

Baseline, Week 26

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections)

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Geometric Least Squares Mean

95% Confidence Interval

percentage change

Baseline, Week 50

ID	Title	Description
OG000	IgAN Cohort - Ravulizumab	Participants with immunoglobulin A nephropathy (IgAN) received a body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
OG001	IgAN Cohort - Placebo	Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).

Secondary

LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections)

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Geometric Least Squares Mean

95% Confidence Interval

percentage change

Baseline, Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections

Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints.

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Week 26 and Week 50

ID	Title	Description
OG000	IgAN Cohort: Ravulizumab	Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
OG001	IgAN Cohort: Placebo	Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).

Secondary

LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections

Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints.

FAS included all randomized participants who received at least 1 dose of the study intervention.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Week 26 and Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

IgAN Cohort: 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 a reduction in symptoms.

Posted

Least Squares Mean

95% Confidence Interval

mL/min/1.73 m^2

Baseline, Week 26 and Week 50

ID	Title	Description
OG000	IgAN Cohort: Ravulizumab	Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
OG001

Secondary

LN Cohort: Change From Baseline in 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 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 a reduction in symptoms.

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

mL/min/1.73 m^2

Baseline, Week 26 and Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50

Posted

Mean

Standard Deviation

grams/liter

Baseline, Week 26 and Week 50

ID	Title	Description
OG000	IgAN Cohort: Ravulizumab	Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
OG001	IgAN Cohort: Placebo	Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).

Secondary

LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

grams/liter

Baseline, Week 26 and Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Units	Counts
Participants

Secondary

LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response (CRR)

The CRR was defined as meeting all 3 of the following criteria: - UPCR ≤0.5 gram/gram (g/g); - eGFR >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.

FAS included all randomized participants who received at least 1 dose of the study intervention.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26 and Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response (PRR)

The PRR was defined as meeting all 3 of the following criteria: - decrease of UPCR >50% from baseline; - eGFR >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.

FAS included all randomized participants who received at least 1 dose of the study intervention.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26 and Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

LN Cohort: Time to Urine Protein to Creatinine Ratio (UPCR) < 0.5 g/g, as Measured by Spot Urine Samples

FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

days

Baseline through Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Units	Counts
Participants

Secondary

LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 Milligrams (mg)/Day

A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator.

Posted

Number

95% Confidence Interval

percentage of participants

Week 14, Week 26, and Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

LN Cohort: Percentage of Participants With Renal Flare

Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a CRR, 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, 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.

FAS included all randomized participants who received at least 1 dose of the study intervention.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

LN Cohort: Percentage of Participants With Extrarenal Systemic Lupus Erythematosus (SLE) Flare

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 assess 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.

FAS included all randomized participants who received at least 1 dose of the study intervention.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

LN Cohort: Percentage of Participants With 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.

FAS included all randomized participants who received at least 1 dose of the study intervention.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

LN Cohort: Percentage of Participants With Suboptimal Response

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.

FAS included all randomized participants who received at least 1 dose of the study intervention.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline through Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

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.

Posted

Mean

Standard Deviation

grams/liter

Baseline, Week 26, Week 50

ID	Title	Description
OG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
OG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).

Secondary

IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission

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.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26 and Week 50

ID	Title	Description
OG000	IgAN Cohort: Ravulizumab	Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
OG001	IgAN Cohort: Placebo	Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0011 affected19 at risk EG0021 affected43 at risk EG0030 affected23 at risk EG0041 affected36 at risk EG0050 affected18 at risk EG0060 affected42 at risk EG0070 affected23 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0011 affected19 at risk EG0020 affected43 at risk EG003
Cellulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0011 affected19 at risk EG0020 affected43 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0011 affected19 at risk EG0020 affected43 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Seizure	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Depression	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Lupus nephritis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Bronchitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Epstein-Barr virus infection reactivation	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 affected38 at risk EG0010 affected19 at risk EG0020 affected43 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG0030 events0 affected23 at risk EG0040 events0 affected36 at risk EG0050 events0 affected18 at risk EG0060 events0 affected42 at risk EG0070 events0 affected23 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Palpitations	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Cushingoid	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0013 events3 affected19 at risk EG0020 events0 affected43 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Optic nerve disorder	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0009 events6 affected38 at risk EG0013 events2 affected19 at risk EG0025 events4 affected43 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected38 at risk EG0012 events2 affected19 at risk EG0021 events1 affected43 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Salivary gland enlargement	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0013 events3 affected19 at risk EG0020 events0 affected43 at risk EG003
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0023 events3 affected43 at risk EG003
Influenza like illness	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Malaise	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Peripheral swelling	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events2 affected19 at risk EG0020 events0 affected43 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Oedema	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Vaccination site pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected38 at risk EG0010 events0 affected19 at risk EG0026 events5 affected43 at risk EG003
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0011 events1 affected19 at risk EG0024 events4 affected43 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected38 at risk EG0012 events2 affected19 at risk EG0020 events0 affected43 at risk EG003
Influenza	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0010 events0 affected19 at risk EG0022 events2 affected43 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Oral herpes	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events2 affected19 at risk EG0020 events0 affected43 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Bronchitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Fungal foot infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Localised infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Periodontitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0014 events2 affected19 at risk EG0020 events0 affected43 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0022 events2 affected43 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Liver function test increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0012 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected38 at risk EG0013 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0013 events2 affected19 at risk EG0020 events0 affected43 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected38 at risk EG0012 events2 affected19 at risk EG0020 events0 affected43 at risk EG003
Sciatica	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Tremor	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Somnolence	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected38 at risk EG0012 events2 affected19 at risk EG0024 events3 affected43 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Diffuse alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Butterfly rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Chronic cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected19 at risk EG0020 events0 affected43 at risk EG003
Essential hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected38 at risk EG0010 events0 affected19 at risk EG0020 events0 affected43 at risk EG003

ID	Term
D008181	Lupus Nephritis
D005922	Glomerulonephritis, IGA
D005921	Glomerulonephritis

ID	Term
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D008180	Lupus Erythematosus, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	LN Cohort: Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance regimen during the Extension Period (24 weeks).
BG001	LN Cohort: Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants continued on the same maintenance doses of ravulizumab matched placebo during the Extension Period (24 weeks).
BG002	IgAN Cohort: Ravulizumab	Participants with IgAN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
BG003	IgAN Cohort: Placebo	Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks). Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Initial Evaluation Period: LN Cohort - Ravulizumab	Participants with LN received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during the Initial Evaluation Period (26 weeks).	38	6	38	28	38
EG001	Initial Evaluation Period: LN Cohort - Placebo	Participants with LN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	19	2	19	15	19
EG002	Initial Evaluation Period: IgAN Cohort - Ravulizumab	Participants with immunoglobulin A nephropathy (IgAN) received body weight-based loading dose of ravulizumab IV infusion on Day 1, followed by body weight-based maintenance doses of ravulizumab on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	43	1	43	17	43
EG003	Initial Evaluation Period: IgAN Cohort - Placebo	Participants with IgAN received a loading dose of ravulizumab matched placebo IV infusion on Day 1, followed by maintenance doses of ravulizumab matched placebo on Day 15 and then q8w thereafter during both the Initial Evaluation Period (26 weeks).	23	0	23	9	23
EG004	Extension Period: LN Cohort - Ravulizumab to Ravulizumab	Participants continued on the same maintenance regimen (as received during the Initial Evaluation Period) during the Extension Period (24 weeks).	36	6	36	14	36
EG005	Extension Period: LN Cohort - Placebo to Placebo	Participants continued to receive ravulizumab matched placebo q8w until the end of the Extension Period (24 weeks).	18	2	18	16	18
EG006	Extension Period: IgAN Cohort - Ravulizumab to Ravulizumab	Participants received a blinded dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	42	0	42	11	42
EG007	Extension Period: IgAN Cohort - Placebo to Ravulizumab	Participants switched to receive a blinded loading dose of ravulizumab at Week 26 and then open-label body weight-based dosing of ravulizumab q8w until the end of the Extension Period (24 weeks).	23	0	23	2	23