Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
Recruiting · NCT05268289 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
Iptacopan (part 1)Iptacopan (part 2)Iptacopan + placeboPlacebo + standard of care
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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)
- ther protocol-defined inclusion/exclusion criteria may apply
Where it is running
60 locations listed across 16 US states.
- 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 - Aguascalientes, Mexico
- Novartis Investigative Site - Ashkelon, Israel
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Beijing, China
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Budapest, Hungary
- Novartis Investigative Site - Cambridge, United Kingdom
- Novartis Investigative Site - Carnaxide, Portugal
- Novartis Investigative Site - Ciudad Real, Spain
- Novartis Investigative Site - Coimbra, Portugal
- Novartis Investigative Site - Iloilo City, Philippines
- Novartis Investigative Site - Jerusalem, Israel
- Novartis Investigative Site - Leicester, United Kingdom
- Novartis Investigative Site - Lisbon, Portugal
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Madrid, Spain
- Novartis Investigative Site - Mainz, Germany
- Novartis Investigative Site - Marseille, France
- Novartis Investigative Site - Montería, Colombia
- Novartis Investigative Site - Nantes, France
- Novartis Investigative Site - Paris, France
- Novartis Investigative Site - Porto, Portugal
- Novartis Investigative Site - Puducherry, India
- Novartis Investigative Site - Quezon, Philippines
- Novartis Investigative Site - Ramat Gan, Israel
- Novartis Investigative Site - Salvador, Brazil
- FDI Clinical Research - San Juan, Puerto Rico
- Novartis Investigative Site - San Luis, Argentina
- Novartis Investigative Site - Santa Fe, Argentina
- Novartis Investigative Site - Selangor Darul Ehsan, Malaysia
- Novartis Investigative Site - Seville, Spain
- Novartis Investigative Site - Shenzhen, China
- Novartis Investigative Site - Strasbourg, France
- Novartis Investigative Site - Szeged, Hungary
Showing 60 of 103 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →