Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
NCT ID: NCT05268289
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2022-08-10
2028-09-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Iptacopan + standard of care (part 1)
Iptacopan + standard of care
Iptacopan (part 1)
Taken for 52 Weeks
Placebo matching iptacopan + standard of care (part 1)
Placebo matching iptacopan standard of care
Placebo + standard of care
Taken for 52 Weeks
Iptacopan + standard of care (part 2)
Iptacopan + standard of care
Iptacopan (part 2)
Taken for 52 Weeks
Iptacopan + placebo (part 2)
Iptacopan + placebo standard of care
Iptacopan + placebo
Taken for 52 Weeks
Placebo matching iptacopan + standard of care (part 2)
Placebo matching iptacopan + standard of care
Placebo + standard of care
Taken for 52 Weeks
Interventions
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Iptacopan (part 1)
Taken for 52 Weeks
Iptacopan (part 2)
Taken for 52 Weeks
Placebo + standard of care
Taken for 52 Weeks
Iptacopan + placebo
Taken for 52 Weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS.
eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study.
First presentation or flare of lupus nephritis.
Exclusion Criteria
Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening.
Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy.
Participants being treated with systemic corticosteroids (\>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease.
Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment)
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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AKDHC Medical Research ServicesLLC
Phoenix, Arizona, United States
Kaiser Permanente Fontana
Fontana, California, United States
Univ Calif Irvine
Irvine, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Loma Linda University
San Bernardino, California, United States
Olive View UCLA Medical Center
Sylmar, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Royal Research Corp
Hollywood, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Nephrology Associates Of Central FL
Orlando, Florida, United States
Florida Kidney Physicians
Riverview, Florida, United States
Florida Kidney Physicians
Riverview, Florida, United States
Nep Assoc of Northern Illinois
Hinsdale, Illinois, United States
Wichita Community Clcl Onco Program
Wichita, Kansas, United States
Ochsner Health System
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Stony Brook Internists PC
East Setauket, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Dallas Nephrology Associates
Dallas, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
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San Luis, , Argentina
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Santa Fe, , Argentina
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Salvador, Estado de Bahia, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Salvador, , Brazil
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Nanning, Guangxi, China
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Wuhan, Hubei, China
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Shenyang, Liaoning, China
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Yinchuan, Ningxia, China
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Beijing, , China
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Shenzhen, , China
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Montería, , Colombia
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Marseille, , France
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Nantes, , France
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Paris, , France
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Strasbourg, , France
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Munich, Bavaria, Germany
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Ludwigshafen, Germany, Germany
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Frankfurt am Main, Hesse, Germany
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Braunschweig, Lower Saxony, Germany
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Cologne, North Rhine-Westphalia, Germany
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Berlin, , Germany
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Mainz, , Germany
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Hong Kong, Hong Kong, Hong Kong
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Debrecen, Hajdu Bihar Megye, Hungary
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Budapest, , Hungary
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Szeged, , Hungary
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Ahmedabad, Gujarat, India
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Kozhikode, Kerala, India
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New Delhi, National Capital Territory of Delhi, India
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Vellore, Tamil Nadu, India
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Hyderabad, Telangana, India
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Lucknow, Uttar Pradesh, India
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Puducherry, , India
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Ashkelon, , Israel
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Jerusalem, , Israel
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Ramat Gan, , Israel
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Kuantan, Pahang, Malaysia
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Taiping, Perak, Malaysia
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Selangor Darul Ehsan, , Malaysia
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Tampico, Tamaulipas, Mexico
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Mérida, Yucatán, Mexico
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Aguascalientes, , Mexico
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Veracruz, , Mexico
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Makati City, National Capital Region, Philippines
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Iloilo City, , Philippines
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Quezon, , Philippines
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Carnaxide, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
FDI Clinical Research
San Juan, , Puerto Rico
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Singapore, Singapore, Singapore
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Port de Sagunt, Valencia, Spain
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Barcelona, , Spain
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Ciudad Real, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Ankara, Bilkent-Cankaya, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Kayseri, Melikgazi, Turkey (Türkiye)
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Bursa, Nilufer, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Mersin, Yenisehir, Turkey (Türkiye)
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Cambridge, , United Kingdom
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Leicester, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Rana Nikbakht Malvajerdi
Role: primary
Gema Castaneda Duenas
Role: primary
Elizabeth Wagner
Role: primary
Yalily Perez
Role: primary
Cameron King
Role: primary
Jamie Coney
Role: primary
Yvette Martinez
Role: primary
Barb Johnson
Role: primary
Gavin Skipper
Role: primary
Valentina Castro
Role: primary
Melissa Espinoza
Role: primary
Sarah Cleveland
Role: primary
Julia Aruta
Role: primary
Dilshad Begum
Role: primary
Keila Najera
Role: primary
Digmarie Rivera Franceschini
Role: primary
References
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Avasare 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.
Other Identifiers
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2021-002046-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLNP023K12201
Identifier Type: -
Identifier Source: org_study_id