Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) (SANCTUARY)

January 6, 2026 updated by: Alexion Pharmaceuticals, Inc.

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Herston, Australia, 4029
        • Research Site
      • Parkville, Australia, 3050
        • Research Site
      • Westmead, Australia, 2145
        • Research Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
      • Québec, Quebec, Canada, G1R 2J6
        • Research Site
  • France
      • Clermont-Ferrand, France, 63003
        • Research Site
      • Le Kremlin-Bicêtre, France, 94270
        • Research Site
      • Paris, France, 75020
        • Research Site
      • Saint-Priest-en-Jarez, France, 42270
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
      • Toulouse, France, 31059
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Essen, Germany, 45147
        • Research Site
      • Hanover, Germany, 30625
        • Research Site
      • Lübeck, Germany, 23538
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Research Site
      • Brescia, Italy, 25123
        • Research Site
      • Florence, Italy, 50134
        • Research Site
      • Torino, Italy, 10154
        • Research Site
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Research Site
  • Poland
      • Lodz, Poland, 92-213
        • Research Site
  • South Korea
      • Anyang-si, South Korea, 14068
        • Research Site
      • Seongnam-si, South Korea, 13620
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 134-727
        • Research Site
      • Seoul, South Korea, 6591
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Lleida, Spain, 25198
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Palma de Mallorca, Spain, 07010
        • Research Site
      • Seville, Spain, 41013
        • Research Site
      • Valencia, Spain, 46017
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Research Site
      • Kaohsiung City, Taiwan, 833401
        • Research Site
      • New Taipei City, Taiwan, 23561
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
  • United Kingdom
      • Edgbaston, United Kingdom, B15 2WB
        • Research Site
      • London, United Kingdom, SE1 7EH
        • Research Site
      • London, United Kingdom, W12 0HS
        • Research Site
      • Salford, United Kingdom, M6 8HD
        • Research Site
  • United States
    • California
      • San Dimas, California, United States, 91773
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
      • South Gate, California, United States, 90280
        • Research Site
      • Stanford, California, United States, 94305
        • Research Site
    • Florida
      • Orlando, Florida, United States, 32835
        • Research Site
      • Plantation, Florida, United States, 33324
        • Research Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
      • Boston, Massachusetts, United States, 02114
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • New York
      • New York, New York, United States, 10003
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Research Site
    • Texas
      • El Paso, Texas, United States, 79935
        • Research Site
      • Houston, Texas, United States, 77054
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Common to both disease cohorts:

  • Proteinuria ≥1 (gram [g]/day or g/g)
  • Vaccinated against meningococcal infection
  • Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements

For LN cohort:

  • Diagnosis of active focal or diffuse proliferative LN Class III or IV
  • Clinically active LN, requiring/receiving immunosuppression induction treatment

For IgAN cohort:

  • Diagnosis of primary IgAN
  • Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months

Exclusion Criteria:

Common to both disease cohorts:

  • eGFR < 30 milliliters/minute/1.73 meters squared
  • Previously received a complement inhibitor (for example, eculizumab)
  • Concomitant significant renal disease other than LN or IgAN
  • History of other solid organ or bone marrow transplant
  • Uncontrolled hypertension

For IgAN cohort:

  • Diagnosis of rapid progressive glomerulonephritis
  • Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive days or any other immunosuppression within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ravulizumab: LN Cohort
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
Dosages (loading and maintenance) will be based on the participant's body weight.
Other Names:
  • Ultomiris
Other: Background Therapy
Participants will receive background therapy consistent with the standard of care.
Placebo Comparator: Placebo: LN Cohort
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.
Other: Background Therapy
Participants will receive background therapy consistent with the standard of care.
Drug: Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.
Experimental: Ravulizumab: IgAN Cohort
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
Dosages (loading and maintenance) will be based on the participant's body weight.
Other Names:
  • Ultomiris
Other: Background Therapy
Participants will receive background therapy consistent with the standard of care.
Placebo Comparator: Placebo: IgAN Cohort
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.
Drug: Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Other Names:
  • Ultomiris
Other: Background Therapy
Participants will receive background therapy consistent with the standard of care.
Drug: Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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)
Time Frame: Baseline, Week 26
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)
Time Frame: Baseline, Week 26
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)
Time Frame: Baseline, Week 50
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
LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections)
Time Frame: Baseline, Week 50
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 50
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
Time Frame: Baseline to Week 26 and Week 50
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.
Baseline to Week 26 and Week 50
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
Time Frame: Baseline to Week 26 and Week 50
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.
Baseline to Week 26 and Week 50
IgAN Cohort: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Time Frame: 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 a reduction in symptoms.
Baseline, Week 26 and Week 50
LN Cohort: Change From Baseline in eGFR at Week 26 and Week 50
Time Frame: 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 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.
Baseline, Week 26 and Week 50
IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50
Time Frame: Baseline, Week 26 and Week 50
Baseline, Week 26 and Week 50
LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50
Time Frame: Baseline, Week 26 and Week 50
Baseline, Week 26 and Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response (CRR)
Time Frame: Week 26 and Week 50
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.
Week 26 and Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response (PRR)
Time Frame: Week 26 and Week 50
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.
Week 26 and Week 50
LN Cohort: Time to Urine Protein to Creatinine Ratio (UPCR) < 0.5 g/g, as Measured by Spot Urine Samples
Time Frame: Baseline through Week 50
Baseline through Week 50
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 Milligrams (mg)/Day
Time Frame: Week 14, Week 26, and Week 50
A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator.
Week 14, Week 26, and Week 50
LN Cohort: Percentage of Participants With Renal Flare
Time Frame: Baseline through Week 50
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.
Baseline through Week 50
LN Cohort: Percentage of Participants With Extrarenal Systemic Lupus Erythematosus (SLE) Flare
Time Frame: 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 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.
Baseline through Week 50
LN Cohort: Percentage of Participants With Treatment Failure
Time Frame: 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.
Baseline through Week 50
LN Cohort: Percentage of Participants With Suboptimal Response
Time Frame: 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.
Baseline through Week 50
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50
Time Frame: Baseline, Week 26, Week 50
For the determination of serum albumin, blood samples were obtained at designated time points.
Baseline, Week 26, Week 50
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission
Time Frame: 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.
Week 26 and Week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALXN1210-NEPH-202
  • 2020-001537-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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