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Clinical Trials in the USA / NCT05268289
Recruiting Phase 2

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

NCT05268289 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2022-08-10
Last updated
2026-07-30

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

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)

Trial sites (103)

FacilityCityRegionStatus
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.

More Novartis Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT05268289 on ClinicalTrials.gov ↗ ← All trials in the USA