Study Stopped
Sponsor Decision.
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
SANCTUARY
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)
2 other identifiers
interventional
123
12 countries
64
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Typical duration for phase_2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedStudy Start
First participant enrolled
January 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2025
CompletedResults Posted
Study results publicly available
January 22, 2026
CompletedJanuary 22, 2026
January 1, 2026
4.2 years
September 21, 2020
January 6, 2026
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (18)
IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections)
Baseline, Week 50
LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections)
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
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
Baseline to Week 26 and Week 50
IgAN Cohort: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Baseline, Week 26 and Week 50
- +13 more secondary outcomes
Study Arms (4)
Ravulizumab: LN Cohort
EXPERIMENTALEligible 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.
Placebo: LN Cohort
PLACEBO COMPARATOREligible 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.
Ravulizumab: IgAN Cohort
EXPERIMENTALEligible 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.
Placebo: IgAN Cohort
PLACEBO COMPARATOREligible 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.
Interventions
Dosages (loading and maintenance) will be based on the participant's body weight.
Dosages (loading and maintenance) will be based on the participant's body weight.
Participants will receive background therapy consistent with the standard of care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Research Site
San Dimas, California, 91773, United States
Research Site
Santa Monica, California, 90404, United States
Research Site
South Gate, California, 90280, United States
Research Site
Stanford, California, 94305, United States
Research Site
Orlando, Florida, 32835, United States
Research Site
Plantation, Florida, 33324, United States
Research Site
Lawrenceville, Georgia, 30046, United States
Research Site
Lexington, Kentucky, 40536, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
Kansas City, Missouri, 64111, United States
Research Site
New York, New York, 10003, United States
Research Site
Chapel Hill, North Carolina, 27599, United States
Research Site
Columbus, Ohio, 43203, United States
Research Site
El Paso, Texas, 79935, United States
Research Site
Houston, Texas, 77054, United States
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Herston, 4029, Australia
Research Site
Parkville, 3050, Australia
Research Site
Westmead, 2145, Australia
Research Site
London, Ontario, N6A 5W9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Québec, Quebec, G1R 2J6, Canada
Research Site
Clermont-Ferrand, 63003, France
Research Site
Le Kremlin-Bicêtre, 94270, France
Research Site
Paris, 75020, France
Research Site
Saint-Priest-en-Jarez, 42270, France
Research Site
Strasbourg, 67091, France
Research Site
Toulouse, 31059, France
Research Site
Berlin, 10117, Germany
Research Site
Essen, 45147, Germany
Research Site
Hanover, 30625, Germany
Research Site
Lübeck, 23538, Germany
Research Site
Bologna, 40138, Italy
Research Site
Brescia, 25123, Italy
Research Site
Florence, 50134, Italy
Research Site
Torino, 10154, Italy
Research Site
Maastricht, 6229 HX, Netherlands
Research Site
Lodz, 92-213, Poland
Research Site
Anyang-si, 14068, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 134-727, South Korea
Research Site
Seoul, 6591, South Korea
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Lleida, 25198, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28040, Spain
Research Site
Madrid, 28041, Spain
Research Site
Málaga, 29010, Spain
Research Site
Palma de Mallorca, 07010, Spain
Research Site
Seville, 41013, Spain
Research Site
Valencia, 46017, Spain
Research Site
Zaragoza, 50009, Spain
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Kaohsiung City, 833401, Taiwan
Research Site
New Taipei City, 23561, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Edgbaston, B15 2WB, United Kingdom
Research Site
London, SE1 7EH, United Kingdom
Research Site
London, W12 0HS, United Kingdom
Research Site
Salford, M6 8HD, United Kingdom
Related Publications (2)
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.
PMID: 39455063DERIVEDAvasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
PMID: 37528520DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The LN cohort of the study was terminated early due to lack of efficacy.
Results Point of Contact
- Title
- Alexion Pharmaceuticals, Inc.
- Organization
- Alexion Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, all investigative site personnel, and any Alexion employee, or designee, directly associated with the conduct of the study will be blinded to participant treatment assignments during the 26-week Initial Evaluation Period. Both the participants and the investigative site personnel will remain blinded for the remaining 24-week Extension Period.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2020
First Posted
September 25, 2020
Study Start
January 19, 2021
Primary Completion
March 26, 2025
Study Completion
August 18, 2025
Last Updated
January 22, 2026
Results First Posted
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share