RecruitingPhase 2NCT05268289

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

240 participants

Start Date

Aug 10, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Iptacopan (part 1), a drug called Iptacopan (part 2), and others for people with lupus nephritis. The study is currently recruiting participants at 103 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIptacopan (part 1)

Taken for 52 Weeks

DRUGIptacopan (part 2)

Taken for 52 Weeks

DRUGPlacebo + standard of care

Taken for 52 Weeks

DRUGIptacopan + placebo

Taken for 52 Weeks


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

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San Luis, Argentina

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Santa Fe, Argentina

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Salvador, Estado de Bahia, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Juiz de Fora, Minas Gerais, Brazil

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Barretos, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Salvador, Brazil

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Nanning, Guangxi, China

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Wuhan, Hubei, China

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Shenyang, Liaoning, China

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Yinchuan, Ningxia, China

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Beijing, China

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Shenzhen, China

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Bucaramanga, Santander Department, Colombia

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Montería, Colombia

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Marseille, France

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Nantes, France

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Paris, France

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Strasbourg, France

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Munich, Bavaria, Germany

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Ludwigshafen, Germany, Germany

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Frankfurt am Main, Hesse, Germany

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Braunschweig, Lower Saxony, Germany

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Cologne, North Rhine-Westphalia, Germany

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Berlin, Germany

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Mainz, Germany

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Hong Kong, Hong Kong, Hong Kong

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Debrecen, Hajdu Bihar Megye, Hungary

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Budapest, Hungary

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Szeged, Hungary

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Ahmedabad, Gujarat, India

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Kozhikode, Kerala, India

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New Delhi, National Capital Territory of Delhi, India

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Vellore, Tamil Nadu, India

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Hyderabad, Telangana, India

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Lucknow, Uttar Pradesh, India

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Puducherry, India

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Ashkelon, Israel

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Jerusalem, Israel

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Ramat Gan, Israel

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Kuantan, Pahang, Malaysia

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Taiping, Perak, Malaysia

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Selangor Darul Ehsan, Malaysia

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Tampico, Tamaulipas, Mexico

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Mérida, Yucatán, Mexico

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Aguascalientes, Mexico

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Veracruz, Mexico

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Makati City, National Capital Region, Philippines

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Iloilo City, Philippines

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Quezon, Philippines

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Carnaxide, Portugal

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Coimbra, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Vila Nova de Gaia, Portugal

FDI Clinical Research

San Juan, Puerto Rico

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Singapore, Singapore, Singapore

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Port de Sagunt, Valencia, Spain

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Barcelona, Spain

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Ciudad Real, Spain

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Madrid, Spain

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Madrid, Spain

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Seville, Spain

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Ankara, Bilkent-Cankaya, Turkey (Türkiye)

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Istanbul, Fatih, Turkey (Türkiye)

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Kayseri, Melikgazi, Turkey (Türkiye)

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Bursa, Nilufer, Turkey (Türkiye)

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Ankara, Yenimahalle, Turkey (Türkiye)

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Mersin, Yenisehir, Turkey (Türkiye)

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Cambridge, United Kingdom

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Leicester, United Kingdom

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NCT05268289


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