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RECRUITING

NCT05268289

PHASE2

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2022-08-10

Completion Date

2028-09-28

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Lupus Nephritis

Interventions

DRUG

Iptacopan (part 1)

Taken for 52 Weeks

DRUG

Iptacopan (part 2)

Taken for 52 Weeks

DRUG

Placebo + standard of care

Taken for 52 Weeks

DRUG

Iptacopan + placebo

Taken for 52 Weeks

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

Locations (103)

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

Novartis Investigative Site

San Luis, Argentina

Novartis Investigative Site

Santa Fe, Argentina

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Juiz de Fora, Minas Gerais, Brazil

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Salvador, Brazil

Novartis Investigative Site

Nanning, Guangxi, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Shenyang, Liaoning, China

Novartis Investigative Site

Yinchuan, Ningxia, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Shenzhen, China

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Montería, Colombia

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Strasbourg, France

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Ludwigshafen, Germany, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Braunschweig, Lower Saxony, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Ahmedabad, Gujarat, India

Novartis Investigative Site

Kozhikode, Kerala, India

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India

Novartis Investigative Site

Vellore, Tamil Nadu, India

Novartis Investigative Site

Hyderabad, Telangana, India

Novartis Investigative Site

Lucknow, Uttar Pradesh, India

Novartis Investigative Site

Puducherry, India

Novartis Investigative Site

Ashkelon, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Kuantan, Pahang, Malaysia

Novartis Investigative Site

Taiping, Perak, Malaysia

Novartis Investigative Site

Selangor Darul Ehsan, Malaysia

Novartis Investigative Site

Tampico, Tamaulipas, Mexico

Novartis Investigative Site

Mérida, Yucatán, Mexico

Novartis Investigative Site

Aguascalientes, Mexico

Novartis Investigative Site

Veracruz, Mexico

Novartis Investigative Site

Makati City, National Capital Region, Philippines

Novartis Investigative Site

Iloilo City, Philippines

Novartis Investigative Site

Quezon, Philippines

Novartis Investigative Site

Carnaxide, Portugal

Novartis Investigative Site

Coimbra, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Porto, Portugal

Novartis Investigative Site

Vila Nova de Gaia, Portugal

FDI Clinical Research

San Juan, Puerto Rico

Novartis Investigative Site

Singapore, Singapore, Singapore

Novartis Investigative Site

Port de Sagunt, Valencia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Ciudad Real, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Seville, Spain

Novartis Investigative Site

Ankara, Bilkent-Cankaya, Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Kayseri, Melikgazi, Turkey (Türkiye)

Novartis Investigative Site

Bursa, Nilufer, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Mersin, Yenisehir, Turkey (Türkiye)

Novartis Investigative Site

Cambridge, United Kingdom

Novartis Investigative Site

Leicester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (103)