Study Stopped
Sponsor Decision.
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
2 other identifiers
interventional
100
16 countries
71
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams \[mg\]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years. Safety will be monitored throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2022
Typical duration for phase_2
71 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
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedStudy Start
First participant enrolled
January 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2024
CompletedResults Posted
Study results publicly available
October 15, 2025
CompletedOctober 15, 2025
September 1, 2025
2.9 years
October 18, 2021
August 15, 2025
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Baseline, Week 26
Secondary Outcomes (13)
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50
Baseline, Week 50
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Week 26 and Week 50
Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Baseline, Week 26 and Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50
Week 26 and Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50
Week 26 and Week 50
- +8 more secondary outcomes
Study Arms (6)
LN Cohort: ALXN2050 180 mg
EXPERIMENTALParticipants diagnosed with LN with an active flare will receive ALXN2050 in addition to standard-of-care background therapy.
LN Cohort: ALXN2050 120 mg
EXPERIMENTALParticipants diagnosed with LN with an active flare will receive ALXN2050 in addition to standard-of-care background therapy.
LN Cohort: Placebo
PLACEBO COMPARATORParticipants diagnosed with LN with an active flare will receive matched placebo in addition to standard-of-care background therapy.
IgAN Cohort: ALXN2050 180 mg
EXPERIMENTALParticipants diagnosed with IgAN will receive ALXN2050 in addition to standard-of-care background therapy.
IgAN Cohort: ALXN2050 120 mg
EXPERIMENTALParticipants diagnosed with IgAN will receive ALXN2050 in addition to standard-of-care background therapy.
IgAN Cohort: Placebo
PLACEBO COMPARATORParticipants diagnosed with IgAN will receive matched placebo in addition to standard-of-care background therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Both Cohorts
- Participants on sodium-glucose cotransporter-2 (SGLT 2) inhibitors (eg, empagliflozin) must be on a stable dose for ≥ 3 months with no planned change in dose during the Blinded Treatment Periods (through Week 50).
- LN Cohort
- Clinical diagnosis of SLE by 2019 American College of Rheumatology and European League Against Rheumatism criteria.
- Diagnosis of 2018 Revised International Society of Nephrology/Renal Pathology Society classification (active focal or diffuse proliferative LN Class III or IV) confirmed by biopsy obtained ≤ 6 months prior to Screening or during Screening Period. Participants may co-exhibit Class V disease. Participants with de novo or relapsing disease may be eligible.
- Clinically active LN at Screening requiring/receiving immunosuppression induction treatment in the opinion of the Investigator.
- Proteinuria with UPCR ≥ 1 g/g based on one 24 hour urine collection during the Screening Period.
- IgAN Cohort
- Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the Screening Period.
- Mean proteinuria ≥ 1 g/day on 2 complete and valid 24 hour urine collections during the Screening Period.
- For participants with a kidney biopsy performed \> 1 year prior to Screening that was used for eligibility: Presence of hematuria as defined by a positive result for blood on urine dipstick or ≥ 10 red blood cells (RBCs)/high power field (hpf) microscopy on urine sediment (documented by the local laboratory) during Screening Period. Presence of hematuria documented by the central laboratory may also be acceptable.
- Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated ACE inhibitor and/or ARB dose for ≥ 3 months prior to Screening with no expected change in dose during the Blinded Treatment Periods (through Week 50) (participants with established intolerance to RAS inhibitors may be included).
- Controlled and stable blood pressure (defined as \< 140/90 millimeters of mercury \[mmHg\]) over the past 3 months prior to randomization.
You may not qualify if:
- Both Cohorts
- eGFR ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration.
- For participants with eGFR \< 45 mL/min/1.73 m2 at Screening, presence of any of the following in glomeruli on most recent kidney biopsy prior to or during the Screening
- Period:
- ≥ 50% interstitial fibrosis and tubular atrophy
- ≥ 50% glomerular sclerosis
- ≥ 50% active crescent formation
- Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period.
- History of solid organ or bone marrow transplant, or planned transplant during the Blinded Extended Treatment Period (50 weeks).
- Splenectomy or functional asplenia.
- Known or suspected complement deficiency, unless attributable to underlying disease (that is, LN and IgAN).
- Bone marrow insufficiency with absolute neutrophil count \< 1.3 × 10\^3/microliter; thrombocytopenia (platelet count \< 50,000/cubic millimeter).
- LN Cohort
- Participants who have initiated any of the following treatments for the current active LN flare:
- Cyclophosphamide ≤ 6 months prior to Screening
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Research Site
Huntsville, Alabama, 35805, United States
Research Site
Loma Linda, California, 92350, United States
Research Site
Northridge, California, 91324, United States
Research Site
Gainesville, Florida, 32603, United States
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Nampa, Idaho, 83687, United States
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Des Moines, Iowa, 50309, United States
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Kansas City, Missouri, 64111, United States
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Albuquerque, New Mexico, 87106, United States
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New York, New York, 10016, United States
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Houston, Texas, 77054, United States
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Ciudad de Buenos Aires, C1015ABO, Argentina
Research Site
Córdoba, 5000, Argentina
Research Site
La Plata, B1902COS, Argentina
Research Site
Rosario, S2000DEJ, Argentina
Research Site
Clayton, 3168, Australia
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Liverpool, 2170, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Westmead, 2145, Australia
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Belo Horizonte, 30150-221, Brazil
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Curitiba, 80030-110, Brazil
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Juiz de Fora, 36010-570, Brazil
Research Site
Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90480-000, Brazil
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Salvador, 40150-150, Brazil
Research Site
Guangzhou, 510080, China
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McKinney, 75069, China
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Shanghai, 200040, China
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Berlin, 10117, Germany
Research Site
Essen, 45122, Germany
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Mainz A. Rhein, 55131, Germany
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Mannheim, 68135, Germany
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Marburg, 30625, Germany
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München, 81377, DE, Germany
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Ashkelon, 78306, Israel
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Haifa, 3109601, Israel
Research Site
Petah Tikva, 4941492, Israel
Research Site
Ramat Gan, 52621, Israel
Research Site
Bari, 70124, Italy
Research Site
Brescia, 25123, Italy
Research Site
Milan, 20132, Italy
Research Site
Napoli, 80131, Italy
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Torino, 10154, Italy
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Guadalajara, 44140, Mexico
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México, 11570, Mexico
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Torreón, 27000, Mexico
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Niš, 18000, Serbia
Research Site
Novi Sad, 21000, Serbia
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Busan, 49241, South Korea
Research Site
Goyang-si, 10380, South Korea
Research Site
Seoul, 03080, South Korea
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Barcelona, 08025, Spain
Research Site
Barcelona, 8003, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Girona, 17007, Spain
Research Site
L'Hospitalet de Llobregat, 08907, Spain
Research Site
Palma de Mallorca, 07120, Spain
Research Site
Seville, 41013, Spain
Research Site
Valencia, 46026, Spain
Research Site
Kaohsiung City, 833, Taiwan
Research Site
New Taipei City, 220, Taiwan
Research Site
New Taipei City, 23561, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Bangkok, 10400, Thailand
Research Site
Istanbul, 34093, Turkey (Türkiye)
Research Site
Bristol, BS105NB, United Kingdom
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Doncaster, DN2 5LT, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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London, E1 1BB, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
Research Site
Manchester, M13 9WL, United Kingdom
Related Publications (2)
Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
PMID: 38299639DERIVEDAvasare 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)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study intervention dosing and recruitment were paused, consistent with a data monitoring committee recommendation. Given the anticipated length of the dosing interruption that would have impacted data interpretation following dosing re-initiation, the sponsor decided to terminate the study.
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking of treatment allocation will be observed at least until Week 50.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2021
First Posted
October 28, 2021
Study Start
January 14, 2022
Primary Completion
December 9, 2024
Study Completion
December 9, 2024
Last Updated
October 15, 2025
Results First Posted
October 15, 2025
Record last verified: 2025-09