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

Last updated: May 29, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

Placebo + standard of care

Iptacopan (part 1)

Iptacopan (part 2)

Clinical Study ID

NCT05268289
CLNP023K12201
2021-002046-33
  • Ages > 18
  • 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 screening 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 10 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 20 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: Placebo + standard of care
Phase: 2
Study Start date:
August 10, 2022
Estimated Completion Date:
March 13, 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

    Sao Paulo, SP 05403 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Beijing, 100034
    China

    Active - Recruiting

  • Novartis Investigative Site

    Wuhan, 430022
    China

    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

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Muenchen, 81377
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Pokfulam,
    Hong Kong

    Active - Recruiting

  • Novartis Investigative Site

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Novartis Investigative Site

    Vellore, Tamil Nadu 632004
    India

    Active - Recruiting

  • Novartis Investigative Site

    New Delhi, 110029
    India

    Active - Recruiting

  • Novartis Investigative Site

    Puducherry, 607403
    India

    Active - Recruiting

  • Novartis Investigative Site

    Ashkelon, 78278
    Israel

    Active - Recruiting

  • 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 8944
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Merida, Yucatan 97070
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

    Veracruz, 91900
    Mexico

    Active - Recruiting

  • Novartis Investigative Site

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

    Active - Recruiting

  • Novartis Investigative Site

    Lisboa, 1600190
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434 502
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    San Juan, 00927
    Puerto Rico

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Sevilla, Andalucia 41009
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Bursa, Gorukle 16059
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Ankara, 06560
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Talas / Kayseri, 38039
    Turkey

    Active - Recruiting

  • Novartis Investigative Site

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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