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

Last updated: April 28, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

Iptacopan (part 1)

Iptacopan (part 2)

Iptacopan + placebo

Clinical Study ID

NCT05268289
CLNP023K12201
2021-002046-33
  • Ages 18-100
  • All Genders

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 Criteria

Inclusion

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

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

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: Iptacopan (part 1)
Phase: 2
Study Start date:
August 10, 2022
Estimated Completion Date:
September 28, 2028

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    San Luis, 5700
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Santa Fe, S3000EPV
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Salvador, BA 40150 150
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Belo Horizonte, MG 30150-221
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Juiz de Fora, MG 36010 570
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Paulo, SP 05403 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Barretos, Sao Paulo 14784 400
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shenyang, Liaoning 110003
    China

    Active - Recruiting

  • Novartis Investigative Site

    Yinchuan, Ningxia 100039
    China

    Active - Recruiting

  • Novartis Investigative Site

    Beijing, 100034
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shenzhen, 518036
    China

    Active - Recruiting

  • Novartis Investigative Site

    Wuhan, 430022
    China

    Active - Recruiting

  • Novartis Investigative Site

    Bogota, Cundinamarca 111411
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Bucaramanga, Santander 0001
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Barranquilla, 080020
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Monteria, 230004
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Marseille, 13385
    France

    Active - Recruiting

  • Novartis Investigative Site

    Nantes Cedex 1, 44093
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris, 75015
    France

    Active - Recruiting

  • Novartis Investigative Site

    Strasbourg Cedex, 67091
    France

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Braunschweig, Niedersachsen 38126
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Koeln, Nordrhein-Westfalen 51109
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ludwigshafen, 67063
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Muenchen, 81377
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Pokfulam,
    Hong Kong

    Active - Recruiting

  • Novartis Investigative Site

    Budapest, H-1083
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Szeged, 6720
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Ahmedabad, Gujarat 380015
    India

    Site Not Available

  • Novartis Investigative Site

    Kozhikode, Kerala 673008
    India

    Active - Recruiting

  • Novartis Investigative Site

    Vellore, Tamil Nadu 632 004
    India

    Active - Recruiting

  • Novartis Investigative Site

    Hyderabad, Telangana 500082
    India

    Active - Recruiting

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh 226014
    India

    Active - Recruiting

  • Novartis Investigative Site

    New Delhi, 110029
    India

    Active - Recruiting

  • Novartis Investigative Site

    Puducherry, 607403
    India

    Site Not Available

  • Novartis Investigative Site

    Ashkelon, 78278
    Israel

    Site Not Available

  • Novartis Investigative Site

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Kuantan, Pahang 25100
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Taiping, Perak 34000
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Selangor Darul Ehsan, 68100
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Tampico, Tamaulipas 89440
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Merida, Yucatan 97070
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Aguascalientes, 20230
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Makati, Metro Manila 1218
    Philippines

    Active - Recruiting

  • Novartis Investigative Site

    Iloilo, 5000
    Philippines

    Active - Recruiting

  • Novartis Investigative Site

    Quezon, 1102
    Philippines

    Active - Recruiting

  • Novartis Investigative Site

    Carnaxide, Lisboa 2799 523
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Carnaxide - Linda-A-Velha, Lisboa 2790-134
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Coimbra, 3000 075
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Lisboa, 1649 035
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Porto, 4200 319
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Vila Nova De Gaia, 4434 502
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434 502
    Portugal

    Active - Recruiting

  • FDI Clinical Research

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Novartis Investigative Site

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, S308433
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Sevilla, Andalucia 41009
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Barcelona, Catalunya 08036
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Puerto De Sagunto, Comunidad Valenciana 46520
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Ciudad Real, 13005
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Ankara, Cankaya 06800
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Bursa, Gorukle 16059
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Mersin, 33110
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Talas / Kayseri, 38039
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Talas Kayseri, 38039
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Leicester, LE5 4PW
    United Kingdom

    Active - Recruiting

  • AKDHC Medical Research ServicesLLC

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Novartis Investigative Site

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Kaiser Permanente Fontana

    Fontana, California 92335
    United States

    Active - Recruiting

  • Univ Calif Irvine

    Irvine, California 92697
    United States

    Active - Recruiting

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Olive View UCLA Medical Center

    Sylmar, California 91342
    United States

    Active - Recruiting

  • University of Colorado Denver

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Royal Research Corp

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Nephrology Associates Of Central FL

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Florida Kidney Physicians

    Riverview, Florida 33578
    United States

    Active - Recruiting

  • Nep Assoc of Northern Illinois

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Wichita Community Clcl Onco Program

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Ochsner Health System

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Stony Brook Internists PC

    East Setauket, New York 11733
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Dallas Nephrology Associates

    Dallas, Texas 75204
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.