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Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
NCT05268289 · Novartis
In plain English
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Official title
An Adaptive, Randomized, Double-blind, Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2 Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in Combination With Standard-of-care With and Without Oral Corticosteroids in Patients With Active Lupus Nephritis Class III-IV, +/- V
About this study
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
Eligibility criteria
Inclusion Criteria:
Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis.
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:
Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization.
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)
Other protocol-defined inclusion/exclusion criteria may apply
Study design
Enrollment target: 240 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2022-08-10
Estimated completion: 2028-09-28
Last updated: 2026-03-20
Interventions
Drug: Iptacopan (part 1)Drug: Iptacopan (part 2)Drug: Placebo + standard of careDrug: Iptacopan + placebo
Primary outcomes
- • Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares (Baseline and week 24)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (103)
AKDHC Medical Research ServicesLLCWithdrawn
Phoenix, Arizona, United States
Kaiser Permanente FontanaWithdrawn
Fontana, California, United States
Univ Calif IrvineActive Not Recruiting
Irvine, California, United States
Ronald Reagan UCLA Medical CenterRecruiting
Los Angeles, California, United States
Loma Linda UniversityActive Not Recruiting
San Bernardino, California, United States
Olive View UCLA Medical CenterActive Not Recruiting
Sylmar, California, United States
University of Colorado DenverRecruiting
Aurora, Colorado, United States
Royal Research CorpRecruiting
Hollywood, Florida, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Nephrology Associates Of Central FLActive Not Recruiting
Orlando, Florida, United States
Florida Kidney PhysiciansRecruiting
Riverview, Florida, United States
Florida Kidney PhysiciansRecruiting
Riverview, Florida, United States
Nep Assoc of Northern IllinoisActive Not Recruiting
Hinsdale, Illinois, United States
Wichita Community Clcl Onco ProgramRecruiting
Wichita, Kansas, United States
Ochsner Health SystemRecruiting
New Orleans, Louisiana, United States
Johns Hopkins HospitalActive Not Recruiting
Baltimore, Maryland, United States
Brigham and Womens Hosp Harvard Med SchoolRecruiting
Boston, Massachusetts, United States
Mayo Clinic RochesterWithdrawn
Rochester, Minnesota, United States
University of Nebraska Medical CenterActive Not Recruiting
Omaha, Nebraska, United States
Stony Brook Internists PCRecruiting
East Setauket, New York, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Temple UniversityRecruiting
Philadelphia, Pennsylvania, United States
Allegheny Health NetworkWithdrawn
Pittsburgh, Pennsylvania, United States
Dallas Nephrology AssociatesActive Not Recruiting
Dallas, Texas, United States
Prolato Clinical Research CenterRecruiting
Houston, Texas, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
Novartis Investigative SiteWithdrawn
Rosario, Santa Fe Province, Argentina
Novartis Investigative SiteWithdrawn
San Luis, Argentina
Novartis Investigative SiteActive Not Recruiting
Santa Fe, Argentina
Novartis Investigative SiteActive Not Recruiting
Salvador, Estado de Bahia, Brazil
Novartis Investigative SiteCompleted
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative SiteActive Not Recruiting
Juiz de Fora, Minas Gerais, Brazil
Novartis Investigative SiteActive Not Recruiting
Barretos, São Paulo, Brazil
Novartis Investigative SiteActive Not Recruiting
São Paulo, São Paulo, Brazil
Novartis Investigative SiteActive Not Recruiting
São Paulo, São Paulo, Brazil
Novartis Investigative SiteCompleted
São Paulo, São Paulo, Brazil
Novartis Investigative SiteActive Not Recruiting
Salvador, Brazil
Novartis Investigative SiteRecruiting
Nanning, Guangxi, China
Novartis Investigative SiteRecruiting
Wuhan, Hubei, China
Novartis Investigative SiteRecruiting
Shenyang, Liaoning, China
Novartis Investigative SiteActive Not Recruiting
Yinchuan, Ningxia, China
Novartis Investigative SiteActive Not Recruiting
Beijing, China
Novartis Investigative SiteRecruiting
Shenzhen, China
Novartis Investigative SiteActive Not Recruiting
Barranquilla, Atlántico, Colombia
Novartis Investigative SiteActive Not Recruiting
Bogota, Cundinamarca, Colombia
Novartis Investigative SiteActive Not Recruiting
Bucaramanga, Santander Department, Colombia
Novartis Investigative SiteActive Not Recruiting
Montería, Colombia
Novartis Investigative SiteCompleted
Marseille, France
Novartis Investigative SiteRecruiting
Nantes, France
Novartis Investigative SiteWithdrawn
Paris, France
Novartis Investigative SiteWithdrawn
Strasbourg, France
Novartis Investigative SiteWithdrawn
Munich, Bavaria, Germany
Novartis Investigative SiteWithdrawn
Ludwigshafen, Germany, Germany
Novartis Investigative SiteWithdrawn
Frankfurt am Main, Hesse, Germany
Novartis Investigative SiteRecruiting
Braunschweig, Lower Saxony, Germany
Novartis Investigative SiteRecruiting
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative SiteWithdrawn
Berlin, Germany
Novartis Investigative SiteRecruiting
Mainz, Germany
Novartis Investigative SiteActive Not Recruiting
Hong Kong, Hong Kong, Hong Kong
Novartis Investigative SiteWithdrawn
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative SiteWithdrawn
Budapest, Hungary
Novartis Investigative SiteWithdrawn
Szeged, Hungary
Novartis Investigative SiteWithdrawn
Ahmedabad, Gujarat, India
Novartis Investigative SiteRecruiting
Kozhikode, Kerala, India
Novartis Investigative SiteRecruiting
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative SiteWithdrawn
Vellore, Tamil Nadu, India
Novartis Investigative SiteRecruiting
Hyderabad, Telangana, India
Novartis Investigative SiteRecruiting
Lucknow, Uttar Pradesh, India
Novartis Investigative SiteWithdrawn
Puducherry, India
Novartis Investigative SiteWithdrawn
Ashkelon, Israel
Novartis Investigative SiteWithdrawn
Jerusalem, Israel
Novartis Investigative SiteWithdrawn
Ramat Gan, Israel
Novartis Investigative SiteRecruiting
Kuantan, Pahang, Malaysia
Novartis Investigative SiteRecruiting
Taiping, Perak, Malaysia
Novartis Investigative SiteRecruiting
Selangor Darul Ehsan, Malaysia
Novartis Investigative SiteActive Not Recruiting
Tampico, Tamaulipas, Mexico
Novartis Investigative SiteActive Not Recruiting
Mérida, Yucatán, Mexico
Novartis Investigative SiteCompleted
Aguascalientes, Mexico
Novartis Investigative SiteActive Not Recruiting
Veracruz, Mexico
Novartis Investigative SiteRecruiting
Makati City, National Capital Region, Philippines
Novartis Investigative SiteWithdrawn
Iloilo City, Philippines
Novartis Investigative SiteRecruiting
Quezon, Philippines
Novartis Investigative SiteActive Not Recruiting
Carnaxide, Portugal
Novartis Investigative SiteActive Not Recruiting
Coimbra, Portugal
Novartis Investigative SiteActive Not Recruiting
Lisbon, Portugal
Novartis Investigative SiteWithdrawn
Porto, Portugal
Novartis Investigative SiteRecruiting
Vila Nova de Gaia, Portugal
FDI Clinical ResearchRecruiting
San Juan, Puerto Rico
Novartis Investigative SiteRecruiting
Singapore, Singapore, Singapore
Novartis Investigative SiteWithdrawn
Port de Sagunt, Valencia, Spain
Novartis Investigative SiteActive Not Recruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Ciudad Real, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteActive Not Recruiting
Seville, Spain
Novartis Investigative SiteActive Not Recruiting
Ankara, Bilkent-Cankaya, Turkey (Türkiye)
Novartis Investigative SiteActive Not Recruiting
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative SiteActive Not Recruiting
Kayseri, Melikgazi, Turkey (Türkiye)
Novartis Investigative SiteRecruiting
Bursa, Nilufer, Turkey (Türkiye)
Novartis Investigative SiteActive Not Recruiting
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative SiteCompleted
Mersin, Yenisehir, Turkey (Türkiye)
Novartis Investigative SiteActive Not Recruiting
Cambridge, United Kingdom
Novartis Investigative SiteWithdrawn
Leicester, United Kingdom