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NCT05268289PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

8/10/2022

Completion Date

9/28/2028

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.

Detailed Description

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 Criteria

Age Range: 18 years to 100 years

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

Interventions

DRUG

Iptacopan (part 1)

DRUG

Iptacopan (part 2)

DRUG

Placebo + standard of care

DRUG

Iptacopan + placebo

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Conditions

Lupus Nephritis

Locations

AKDHC Medical Research ServicesLLC

Phoenix, Arizona 85016

United States

Kaiser Permanente Fontana

Fontana, California 92335

United States

Univ Calif Irvine

Irvine, California 92697

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

United States

Loma Linda University

San Bernardino, California 92408

United States

Olive View UCLA Medical Center

Sylmar, California 91342

United States

University of Colorado Denver

Aurora, Colorado 80045

United States

Royal Research Corp

Hollywood, Florida 33021

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Nephrology Associates Of Central FL

Orlando, Florida 32806

United States

Florida Kidney Physicians

Riverview, Florida 33578

United States

Florida Kidney Physicians

Riverview, Florida 33578

United States

Nep Assoc of Northern Illinois

Hinsdale, Illinois 60521

United States

Wichita Community Clcl Onco Program

Wichita, Kansas 67214

United States

Ochsner Health System

New Orleans, Louisiana 70121

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts 02115

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Stony Brook Internists PC

East Setauket, New York 11733

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Temple University

Philadelphia, Pennsylvania 19140

United States

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States

Dallas Nephrology Associates

Dallas, Texas 75204

United States

Prolato Clinical Research Center

Houston, Texas 77054

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States

Novartis Investigative Site

Rosario, Santa Fe Province 2000

Argentina

Novartis Investigative Site

San Luis, D5700CGQ

Argentina

Novartis Investigative Site

Santa Fe, S3000EPV

Argentina

Novartis Investigative Site

Salvador, Estado de Bahia 40150 150

Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais 30150-221

Brazil

Novartis Investigative Site

Juiz de Fora, Minas Gerais 36010 570

Brazil

Novartis Investigative Site

Barretos, São Paulo 14784 400

Brazil

Novartis Investigative Site

São Paulo, São Paulo 01308-050

Brazil

Novartis Investigative Site

São Paulo, São Paulo 04038-002

Brazil

Novartis Investigative Site

São Paulo, São Paulo 05403 000

Brazil

Novartis Investigative Site

Salvador, 40323-010

Brazil

Novartis Investigative Site

Nanning, Guangxi 530022

China

Novartis Investigative Site

Wuhan, Hubei 430022

China

Novartis Investigative Site

Shenyang, Liaoning 110004

China

Novartis Investigative Site

Yinchuan, Ningxia 750004

China

Novartis Investigative Site

Beijing, 100034

China

Novartis Investigative Site

Shenzhen, 518036

China

Novartis Investigative Site

Barranquilla, Atlántico 080020

Colombia

Novartis Investigative Site

Bogota, Cundinamarca 111411

Colombia

Novartis Investigative Site

Bucaramanga, Santander Department 680003

Colombia

Novartis Investigative Site

Montería, 230004

Colombia

Novartis Investigative Site

Marseille, 13005

France

Novartis Investigative Site

Nantes, 44093

France

Novartis Investigative Site

Paris, 75015

France

Novartis Investigative Site

Strasbourg, 67091

France

Novartis Investigative Site

Munich, Bavaria 81377

Germany

Novartis Investigative Site

Ludwigshafen, Germany 67063

Germany

Novartis Investigative Site

Frankfurt am Main, Hesse 60590

Germany

Novartis Investigative Site

Braunschweig, Lower Saxony 38126

Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia 51109

Germany

Novartis Investigative Site

Berlin, 13353

Germany

Novartis Investigative Site

Mainz, 55131

Germany

Novartis Investigative Site

Hong Kong, Hong Kong 999077

Hong Kong

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye 4032

Hungary

Novartis Investigative Site

Budapest, H-1083

Hungary

Novartis Investigative Site

Szeged, 6725

Hungary

Novartis Investigative Site

Ahmedabad, Gujarat 380015

India

Novartis Investigative Site

Kozhikode, Kerala 673008

India

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi 110029

India

Novartis Investigative Site

Vellore, Tamil Nadu 632 004

India

Novartis Investigative Site

Hyderabad, Telangana 500082

India

Novartis Investigative Site

Lucknow, Uttar Pradesh 226014

India

Novartis Investigative Site

Puducherry, 607402

India

Novartis Investigative Site

Ashkelon, 7830604

Israel

Novartis Investigative Site

Jerusalem, 9112001

Israel

Novartis Investigative Site

Ramat Gan, 5265601

Israel

Novartis Investigative Site

Kuantan, Pahang 25100

Malaysia

Novartis Investigative Site

Taiping, Perak 34000

Malaysia

Novartis Investigative Site

Selangor Darul Ehsan, 68100

Malaysia

Novartis Investigative Site

Tampico, Tamaulipas 89440

Mexico

Novartis Investigative Site

Mérida, Yucatán 97070

Mexico

Novartis Investigative Site

Aguascalientes, 20230

Mexico

Novartis Investigative Site

Veracruz, 91900

Mexico

Novartis Investigative Site

Makati City, National Capital Region 1218

Philippines

Novartis Investigative Site

Iloilo City, 5000

Philippines

Novartis Investigative Site

Quezon, 1102

Philippines

Novartis Investigative Site

Carnaxide, 2799-523

Portugal

Novartis Investigative Site

Coimbra, 3004-561

Portugal

Novartis Investigative Site

Lisbon, 1649-035

Portugal

Novartis Investigative Site

Porto, 4200 319

Portugal

Novartis Investigative Site

Vila Nova de Gaia, 4434 502

Portugal

FDI Clinical Research

San Juan, 00927

Puerto Rico

Novartis Investigative Site

Singapore, Singapore S308433

Singapore

Novartis Investigative Site

Port de Sagunt, Valencia 46520

Spain

Novartis Investigative Site

Barcelona, 08036

Spain

Novartis Investigative Site

Ciudad Real, 13005

Spain

Novartis Investigative Site

Madrid, 28034

Spain

Novartis Investigative Site

Madrid, 28040

Spain

Novartis Investigative Site

Seville, 41009

Spain

Novartis Investigative Site

Ankara, Bilkent-Cankaya 06800

Turkey (Türkiye)

Novartis Investigative Site

Istanbul, Fatih 34093

Turkey (Türkiye)

Novartis Investigative Site

Kayseri, Melikgazi 38039

Turkey (Türkiye)

Novartis Investigative Site

Bursa, Nilufer 16059

Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle 06500

Turkey (Türkiye)

Novartis Investigative Site

Mersin, Yenisehir 33110

Turkey (Türkiye)

Novartis Investigative Site

Cambridge, CB2 0QQ

United Kingdom

Novartis Investigative Site

Leicester, LE5 4PW

United Kingdom