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

May 28, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • San Luis, Argentina, 5700
        • Withdrawn
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EPV
        • Active, not recruiting
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Withdrawn
        • Novartis Investigative Site
  • Brazil
      • Salvador, Brazil, 40323-010
        • Active, not recruiting
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150 150
        • Active, not recruiting
        • Novartis Investigative Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Completed
        • Novartis Investigative Site
      • Juiz de Fora, Minas Gerais, Brazil, 36010 570
        • Active, not recruiting
        • Novartis Investigative Site
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784 400
        • Active, not recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04038-002
        • Active, not recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 01308-050
        • Active, not recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 05403 000
        • Completed
        • Novartis Investigative Site
  • China
      • Beijing, China, 100034
        • Active, not recruiting
        • Novartis Investigative Site
      • Shenzhen, China, 518036
        • Recruiting
        • Novartis Investigative Site
    • Guangxi
      • Nanning, Guangxi, China, 530022
        • Recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Novartis Investigative Site
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Active, not recruiting
        • Novartis Investigative Site
  • Colombia
      • Montería, Colombia, 230004
        • Active, not recruiting
        • Novartis Investigative Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Active, not recruiting
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111411
        • Active, not recruiting
        • Novartis Investigative Site
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 680003
        • Active, not recruiting
        • Novartis Investigative Site
  • France
      • Marseille, France, 13005
        • Completed
        • Novartis Investigative Site
      • Nantes, France, 44093
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75015
        • Withdrawn
        • Novartis Investigative Site
      • Strasbourg, France, 67091
        • Withdrawn
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Withdrawn
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Withdrawn
        • Novartis Investigative Site
    • Germany
      • Ludwigshafen, Germany, Germany, 67063
        • Withdrawn
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Withdrawn
        • Novartis Investigative Site
    • Lower Saxony
      • Braunschweig, Lower Saxony, Germany, 38126
        • Recruiting
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 51109
        • Recruiting
        • Novartis Investigative Site
  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 999077
        • Active, not recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H-1083
        • Withdrawn
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Withdrawn
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Withdrawn
        • Novartis Investigative Site
  • India
      • Puducherry, India, 607402
        • Withdrawn
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Withdrawn
        • Novartis Investigative Site
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Recruiting
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • Novartis Investigative Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632 004
        • Withdrawn
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Withdrawn
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Withdrawn
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Withdrawn
        • Novartis Investigative Site
  • Malaysia
      • Selangor Darul Ehsan, Malaysia, 68100
        • Recruiting
        • Novartis Investigative Site
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Recruiting
        • Novartis Investigative Site
    • Perak
      • Taiping, Perak, Malaysia, 34000
        • Recruiting
        • Novartis Investigative Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Completed
        • Novartis Investigative Site
      • Veracruz, Mexico, 91900
        • Active, not recruiting
        • Novartis Investigative Site
    • Tamaulipas
      • Tampico, Tamaulipas, Mexico, 89440
        • Active, not recruiting
        • Novartis Investigative Site
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Active, not recruiting
        • Novartis Investigative Site
  • Philippines
      • Iloilo City, Philippines, 5000
        • Withdrawn
        • Novartis Investigative Site
      • Quezon, Philippines, 1102
        • Recruiting
        • Novartis Investigative Site
    • National Capital Region
      • Makati City, National Capital Region, Philippines, 1218
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Carnaxide, Portugal, 2799-523
        • Active, not recruiting
        • Novartis Investigative Site
      • Coimbra, Portugal, 3004-561
        • Active, not recruiting
        • Novartis Investigative Site
      • Lisbon, Portugal, 1649-035
        • Active, not recruiting
        • Novartis Investigative Site
      • Porto, Portugal, 4200 319
        • Withdrawn
        • Novartis Investigative Site
      • Vila Nova de Gaia, Portugal, 4434 502
        • Recruiting
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • FDI Clinical Research
        • Principal Investigator:
          • Jose Cangiano
        • Contact:
          • Digmarie Rivera Franceschini
          • Phone Number: +1 787 722 1248
          • Email: drivera@fdipr.com
  • Singapore
    • Singapore
      • Singapore, Singapore, Singapore, S308433
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Novartis Investigative Site
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Recruiting
        • Novartis Investigative Site
      • Seville, Spain, 41009
        • Active, not recruiting
        • Novartis Investigative Site
    • Valencia
      • Port de Sagunt, Valencia, Spain, 46520
        • Withdrawn
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Bilkent-Cankaya
      • Ankara, Bilkent-Cankaya, Turkey (Türkiye), 06800
        • Active, not recruiting
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Active, not recruiting
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Active, not recruiting
        • Novartis Investigative Site
    • Nilufer
      • Bursa, Nilufer, Turkey (Türkiye), 16059
        • Recruiting
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Active, not recruiting
        • Novartis Investigative Site
    • Yenisehir
      • Mersin, Yenisehir, Turkey (Türkiye), 33110
        • Completed
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Active, not recruiting
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE5 4PW
        • Withdrawn
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Withdrawn
        • AKDHC Medical Research ServicesLLC
    • California
      • Fontana, California, United States, 92335
        • Withdrawn
        • Kaiser Permanente Fontana
      • Irvine, California, United States, 92697
        • Active, not recruiting
        • Univ Calif Irvine
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Principal Investigator:
          • Lama Abdelnour
        • Contact:
      • San Bernardino, California, United States, 92408
        • Active, not recruiting
        • Loma Linda University
      • Sylmar, California, United States, 91342
        • Active, not recruiting
        • Olive View UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Royal Research Corp
        • Principal Investigator:
          • Elio Torres
        • Contact:
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Principal Investigator:
          • Nabeel Aslam
        • Contact:
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • Nephrology Associates Of Central FL
      • Riverview, Florida, United States, 33578
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Completed
        • Nep Assoc of Northern Illinois
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Wichita Community Clcl Onco Program
        • Principal Investigator:
          • Wissam Saliba
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Health System
        • Principal Investigator:
          • Ivo Lukitsch
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Womens Hosp Harvard Med School
        • Principal Investigator:
          • Finnian McCausland
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • Mayo Clinic Rochester
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Active, not recruiting
        • University of Nebraska Medical Center
    • New York
      • East Setauket, New York, United States, 11733
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Laura Ferreira-Provenzano
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University
        • Principal Investigator:
          • Iris Lee
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15212
        • Withdrawn
        • Allegheny Health Network
    • Texas
      • Dallas, Texas, United States, 75204
        • Active, not recruiting
        • Dallas Nephrology Associates
      • Houston, Texas, United States, 77054
        • Recruiting
        • Prolato Clinical Research Center
        • Principal Investigator:
          • Biruh Workeneh
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Jason Kidd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iptacopan + standard of care (part 1)
Iptacopan + standard of care
Drug: Iptacopan (part 1)
Taken for 52 Weeks
Other Names:
  • LNP023
Placebo Comparator: Placebo matching iptacopan + standard of care (part 1)
Placebo matching iptacopan standard of care
Drug: Placebo + standard of care
Taken for 52 Weeks
Active Comparator: Iptacopan + standard of care (part 2)
Iptacopan + standard of care
Drug: Iptacopan (part 2)
Taken for 52 Weeks
Other Names:
  • LNP023
Active Comparator: Iptacopan + placebo (part 2)
Iptacopan + placebo standard of care
Drug: Iptacopan + placebo
Taken for 52 Weeks
Other Names:
  • LNP023 and placebo
Active Comparator: Placebo matching iptacopan + standard of care (part 2)
Placebo matching iptacopan + standard of care
Drug: Placebo + standard of care
Taken for 52 Weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares
Time Frame: Baseline and week 24

Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone

Complete Renal Response is defined as meeting the following criteria: estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2 or no less than 85% of baseline value, and 24h urine protein-to-creatinine ratio (UPCR) ≤ 0.5 g/g.
Baseline and week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares
Time Frame: Baseline, week 24, week 52
Proportion of patients achieving complete renal response or partial renal response
Baseline, week 24, week 52
Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24
Time Frame: Baseline, week 24 week 52
Frequency of renal flares between weeks 24 and 52
Baseline, week 24 week 52
Log-transformed ratio to baseline of 24h UPCR at week 24
Time Frame: Baseline week 24
Dose exposure response for reduction in proteinurea. (each 24h urine protein-to-creatinine ratio value will based on two 24 urine collections sampled within 10 days before the respective study visit)
Baseline week 24
Change from baseline FACIT-Fatigue Score
Time Frame: Weeks 24 and 52
Measure fatigue in patients
Weeks 24 and 52
Change from baseline in SLEDAI-2K score at weeks 24 and 52
Time Frame: Weeks 24 and 52
Measure disease activity in SLE
Weeks 24 and 52
Change from baseline in BILAG-2004 score at weeks 24 and 52
Time Frame: Weeks 24 and 52
Measure disease activity
Weeks 24 and 52
Time-to-Complete Renal Response (CRR) based on first morning void(FMV) urine samples
Time Frame: Week 24 and Week 52
Measurement of time to complete renal response based on urine samples
Week 24 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Actual)

March 19, 2026

Study Completion (Estimated)

September 28, 2028

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNP023K12201
  • 2021-002046-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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