Iptacopan (part 1)Iptacopan (part 2)Placebo + standard of careIptacopan + placebo
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
Study summary
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
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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 Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone
Complete Renal Response is defined as meeting the following criteria: estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2 or no less than 85% of baseline value, and 24h urine protein-to-creatinine ratio (UPCR) ≤ 0.5 g/g.
Trial sites (103)
Facility
City
Region
Status
AKDHC Medical Research ServicesLLC
Phoenix
Arizona
Withdrawn
Kaiser Permanente Fontana
Fontana
California
Withdrawn
Univ Calif Irvine
Irvine
California
Withdrawn
Ronald Reagan UCLA Medical Center
Los Angeles
California
Recruiting
Loma Linda University
San Bernardino
California
Active Not Recruiting
Olive View UCLA Medical Center
Sylmar
California
Active Not Recruiting
University of Colorado Denver
Aurora
Colorado
Recruiting
Royal Research Corp
Hollywood
Florida
Recruiting
Mayo Clinic Jacksonville
Jacksonville
Florida
Recruiting
Nephrology Associates Of Central FL
Orlando
Florida
Active Not Recruiting
Florida Kidney Physicians
Riverview
Florida
Recruiting
Florida Kidney Physicians
Riverview
Florida
Recruiting
Nep Assoc of Northern Illinois
Hinsdale
Illinois
Completed
Wichita Community Clcl Onco Program
Wichita
Kansas
Recruiting
Ochsner Health System
New Orleans
Louisiana
Recruiting
Johns Hopkins Hospital
Baltimore
Maryland
Active Not Recruiting
Brigham and Womens Hosp Harvard Med School
Boston
Massachusetts
Recruiting
Mayo Clinic Rochester
Rochester
Minnesota
Withdrawn
University of Nebraska Medical Center
Omaha
Nebraska
Active Not Recruiting
Stony Brook Internists PC
East Setauket
New York
Recruiting
Cleveland Clinic Foundation
Cleveland
Ohio
Recruiting
Temple University
Philadelphia
Pennsylvania
Recruiting
Allegheny Health Network
Pittsburgh
Pennsylvania
Withdrawn
Dallas Nephrology Associates
Dallas
Texas
Active Not Recruiting
Prolato Clinical Research Center
Houston
Texas
Recruiting
Virginia Commonwealth University
Richmond
Virginia
Recruiting
Novartis Investigative Site
Rosario
Santa Fe Province
Withdrawn
Novartis Investigative Site
San Luis
Argentina
Withdrawn
Novartis Investigative Site
Santa Fe
Argentina
Active Not Recruiting
Novartis Investigative Site
Salvador
Estado de Bahia
Active Not Recruiting
Novartis Investigative Site
Belo Horizonte
Minas Gerais
Completed
Novartis Investigative Site
Juiz de Fora
Minas Gerais
Active Not Recruiting
Novartis Investigative Site
Barretos
São Paulo
Active Not Recruiting
Novartis Investigative Site
São Paulo
São Paulo
Active Not Recruiting
Novartis Investigative Site
São Paulo
São Paulo
Active Not Recruiting
Novartis Investigative Site
São Paulo
São Paulo
Completed
Novartis Investigative Site
Salvador
Brazil
Active Not Recruiting
Novartis Investigative Site
Nanning
Guangxi
Completed
Novartis Investigative Site
Wuhan
Hubei
Recruiting
Novartis Investigative Site
Shenyang
Liaoning
Recruiting
+ 63 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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