Actively Recruiting

Phase 2
Age: 18Years - 100Years
All Genders
NCT05268289

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

Led by Novartis Pharmaceuticals · Updated on 2026-04-20

240

Participants Needed

103

Research Sites

320 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Positive ANA test or positive anti-dsDNA test at screening
  • Active biopsy-confirmed lupus nephritis Class III or IV, with or without Class V, within 3 months prior to screening
  • Active kidney disease requiring corticosteroids combined with MMF or MPS at screening
  • Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73 m2
  • Vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae
  • Receiving supportive care including stable doses of anti-malarials, ACE inhibitors or ARBs at screening
  • First presentation or flare of lupus nephritis
Not Eligible

You will not qualify if you...

  • Induction treatment with cyclophosphamide within 3 months before planned study treatment
  • Treatment with calcineurin inhibitors within 3 months prior to randomization
  • Rapidly progressive glomerulonephritis defined by 50% decline in eGFR within 3 months before screening
  • Renal biopsy showing more than 50% interstitial fibrosis/tubular atrophy or glomerulosclerosis or judged unlikely to respond to immunosuppressive therapy
  • Taking systemic corticosteroids over 5 mg/day prednisone equivalent for conditions other than SLE or lupus nephritis
  • For SLE or lupus nephritis, corticosteroid use exceeding average 15 mg/day prednisone equivalent in past 4 weeks or 30 mg/day in past week
  • Receipt of more than 1000 mg total dose of intravenous methylprednisolone pulses within 2 weeks prior to enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 103 locations

1

AKDHC Medical Research ServicesLLC

Phoenix, Arizona, United States, 85016

Withdrawn

2

Kaiser Permanente Fontana

Fontana, California, United States, 92335

Withdrawn

3

Univ Calif Irvine

Irvine, California, United States, 92697

Active, Not Recruiting

4

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

5

Loma Linda University

San Bernardino, California, United States, 92408

Active, Not Recruiting

6

Olive View UCLA Medical Center

Sylmar, California, United States, 91342

Active, Not Recruiting

7

University of Colorado Denver

Aurora, Colorado, United States, 80045

Actively Recruiting

8

Royal Research Corp

Hollywood, Florida, United States, 33021

Actively Recruiting

9

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

Actively Recruiting

10

Nephrology Associates Of Central FL

Orlando, Florida, United States, 32806

Active, Not Recruiting

11

Florida Kidney Physicians

Riverview, Florida, United States, 33578

Actively Recruiting

12

Florida Kidney Physicians

Riverview, Florida, United States, 33578

Actively Recruiting

13

Nep Assoc of Northern Illinois

Hinsdale, Illinois, United States, 60521

Active, Not Recruiting

14

Wichita Community Clcl Onco Program

Wichita, Kansas, United States, 67214

Actively Recruiting

15

Ochsner Health System

New Orleans, Louisiana, United States, 70121

Actively Recruiting

16

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Active, Not Recruiting

17

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts, United States, 02115

Actively Recruiting

18

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Withdrawn

19

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Active, Not Recruiting

20

Stony Brook Internists PC

East Setauket, New York, United States, 11733

Actively Recruiting

21

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

22

Temple University

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

23

Allegheny Health Network

Pittsburgh, Pennsylvania, United States, 15212

Withdrawn

24

Dallas Nephrology Associates

Dallas, Texas, United States, 75204

Active, Not Recruiting

25

Prolato Clinical Research Center

Houston, Texas, United States, 77054

Actively Recruiting

26

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

27

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina, 2000

Withdrawn

28

Novartis Investigative Site

San Luis, Argentina, 5700

Withdrawn

29

Novartis Investigative Site

Santa Fe, Argentina, S3000EPV

Active, Not Recruiting

30

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil, 40150 150

Active, Not Recruiting

31

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil, 30150-221

Completed

32

Novartis Investigative Site

Juiz de Fora, Minas Gerais, Brazil, 36010 570

Active, Not Recruiting

33

Novartis Investigative Site

Barretos, São Paulo, Brazil, 14784 400

Active, Not Recruiting

34

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 01308-050

Active, Not Recruiting

35

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 04038-002

Active, Not Recruiting

36

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 05403 000

Completed

37

Novartis Investigative Site

Salvador, Brazil, 40323-010

Active, Not Recruiting

38

Novartis Investigative Site

Nanning, Guangxi, China, 530022

Actively Recruiting

39

Novartis Investigative Site

Wuhan, Hubei, China, 430022

Actively Recruiting

40

Novartis Investigative Site

Shenyang, Liaoning, China, 110004

Actively Recruiting

41

Novartis Investigative Site

Yinchuan, Ningxia, China, 750004

Active, Not Recruiting

42

Novartis Investigative Site

Beijing, China, 100034

Active, Not Recruiting

43

Novartis Investigative Site

Shenzhen, China, 518036

Actively Recruiting

44

Novartis Investigative Site

Barranquilla, Atlántico, Colombia, 080020

Active, Not Recruiting

45

Novartis Investigative Site

Bogota, Cundinamarca, Colombia, 111411

Active, Not Recruiting

46

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia, 680003

Active, Not Recruiting

47

Novartis Investigative Site

Montería, Colombia, 230004

Active, Not Recruiting

48

Novartis Investigative Site

Marseille, France, 13005

Completed

49

Novartis Investigative Site

Nantes, France, 44093

Actively Recruiting

50

Novartis Investigative Site

Paris, France, 75015

Withdrawn

51

Novartis Investigative Site

Strasbourg, France, 67091

Withdrawn

52

Novartis Investigative Site

Munich, Bavaria, Germany, 81377

Withdrawn

53

Novartis Investigative Site

Ludwigshafen, Germany, Germany, 67063

Withdrawn

54

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany, 60590

Withdrawn

55

Novartis Investigative Site

Braunschweig, Lower Saxony, Germany, 38126

Actively Recruiting

56

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany, 51109

Actively Recruiting

57

Novartis Investigative Site

Berlin, Germany, 13353

Withdrawn

58

Novartis Investigative Site

Mainz, Germany, 55131

Actively Recruiting

59

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong, 999077

Active, Not Recruiting

60

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary, 4032

Withdrawn

61

Novartis Investigative Site

Budapest, Hungary, H-1083

Withdrawn

62

Novartis Investigative Site

Szeged, Hungary, 6725

Withdrawn

63

Novartis Investigative Site

Ahmedabad, Gujarat, India, 380015

Withdrawn

64

Novartis Investigative Site

Kozhikode, Kerala, India, 673008

Actively Recruiting

65

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

66

Novartis Investigative Site

Vellore, Tamil Nadu, India, 632 004

Withdrawn

67

Novartis Investigative Site

Hyderabad, Telangana, India, 500082

Actively Recruiting

68

Novartis Investigative Site

Lucknow, Uttar Pradesh, India, 226014

Actively Recruiting

69

Novartis Investigative Site

Puducherry, India, 607402

Withdrawn

70

Novartis Investigative Site

Ashkelon, Israel, 7830604

Withdrawn

71

Novartis Investigative Site

Jerusalem, Israel, 9112001

Withdrawn

72

Novartis Investigative Site

Ramat Gan, Israel, 5265601

Withdrawn

73

Novartis Investigative Site

Kuantan, Pahang, Malaysia, 25100

Actively Recruiting

74

Novartis Investigative Site

Taiping, Perak, Malaysia, 34000

Actively Recruiting

75

Novartis Investigative Site

Selangor Darul Ehsan, Malaysia, 68100

Actively Recruiting

76

Novartis Investigative Site

Tampico, Tamaulipas, Mexico, 89440

Active, Not Recruiting

77

Novartis Investigative Site

Mérida, Yucatán, Mexico, 97070

Active, Not Recruiting

78

Novartis Investigative Site

Aguascalientes, Mexico, 20230

Completed

79

Novartis Investigative Site

Veracruz, Mexico, 91900

Active, Not Recruiting

80

Novartis Investigative Site

Makati City, National Capital Region, Philippines, 1218

Actively Recruiting

81

Novartis Investigative Site

Iloilo City, Philippines, 5000

Withdrawn

82

Novartis Investigative Site

Quezon, Philippines, 1102

Actively Recruiting

83

Novartis Investigative Site

Carnaxide, Portugal, 2799-523

Active, Not Recruiting

84

Novartis Investigative Site

Coimbra, Portugal, 3004-561

Active, Not Recruiting

85

Novartis Investigative Site

Lisbon, Portugal, 1649-035

Active, Not Recruiting

86

Novartis Investigative Site

Porto, Portugal, 4200 319

Withdrawn

87

Novartis Investigative Site

Vila Nova de Gaia, Portugal, 4434 502

Actively Recruiting

88

FDI Clinical Research

San Juan, Puerto Rico, 00927

Actively Recruiting

89

Novartis Investigative Site

Singapore, Singapore, Singapore, S308433

Actively Recruiting

90

Novartis Investigative Site

Port de Sagunt, Valencia, Spain, 46520

Withdrawn

91

Novartis Investigative Site

Barcelona, Spain, 08036

Active, Not Recruiting

92

Novartis Investigative Site

Ciudad Real, Spain, 13005

Actively Recruiting

93

Novartis Investigative Site

Madrid, Spain, 28034

Actively Recruiting

94

Novartis Investigative Site

Madrid, Spain, 28040

Actively Recruiting

95

Novartis Investigative Site

Seville, Spain, 41009

Active, Not Recruiting

96

Novartis Investigative Site

Ankara, Bilkent-Cankaya, Turkey (Türkiye), 06800

Active, Not Recruiting

97

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye), 34093

Active, Not Recruiting

98

Novartis Investigative Site

Kayseri, Melikgazi, Turkey (Türkiye), 38039

Active, Not Recruiting

99

Novartis Investigative Site

Bursa, Nilufer, Turkey (Türkiye), 16059

Actively Recruiting

100

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye), 06500

Active, Not Recruiting

101

Novartis Investigative Site

Mersin, Yenisehir, Turkey (Türkiye), 33110

Completed

102

Novartis Investigative Site

Cambridge, United Kingdom, CB2 0QQ

Active, Not Recruiting

103

Novartis Investigative Site

Leicester, United Kingdom, LE5 4PW

Withdrawn

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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