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

NCT05268289 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CLNP023K122012021-002046-33
• Study Type: interventional
• Target: 240
• Locations: 20 countries
• Sites: 103

Brief 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.

Conditions

Lupus Nephritis

Keywords

LNP023; Iptacopan; Lupus Nephritis; proteinuria; Urine Protein-to-Creatinine Ratio; complete renal response; estimated glomerular filtration rate; renal flares; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares

  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 Outcomes (7)

• Parts 1 and 2: Proportion of patients achieving CRR or PRR in the absence of renal flares

  Baseline, week 24, week 52

• Proportion of patients achieving ≥25% UPCR reduction in the absence of renal flares compared to baseline at week 24

  Baseline, week 24 week 52

• Log-transformed ratio to baseline of 24h UPCR at week 24

  Baseline week 24

• Change from baseline FACIT-Fatigue Score

  Weeks 24 and 52

• Change from baseline in SLEDAI-2K score at weeks 24 and 52

  Weeks 24 and 52

Study Arms (5)

Iptacopan + standard of care (part 1)

ACTIVE COMPARATOR

Iptacopan + standard of care

Drug: Iptacopan (part 1)

Placebo matching iptacopan + standard of care (part 1)

PLACEBO COMPARATOR

Placebo matching iptacopan standard of care

Drug: Placebo + standard of care

Iptacopan + standard of care (part 2)

ACTIVE COMPARATOR

Iptacopan + standard of care

Drug: Iptacopan (part 2)

Iptacopan + placebo (part 2)

ACTIVE COMPARATOR

Iptacopan + placebo standard of care

Drug: Iptacopan + placebo

Placebo matching iptacopan + standard of care (part 2)

ACTIVE COMPARATOR

Placebo matching iptacopan + standard of care

Drug: Placebo + standard of care

Interventions

Iptacopan (part 2) DRUG

Taken for 52 Weeks

Also known as: LNP023

Iptacopan + standard of care (part 2)

Placebo + standard of care DRUG

Taken for 52 Weeks

Placebo matching iptacopan + standard of care (part 1); Placebo matching iptacopan + standard of care (part 2)

Iptacopan + placebo DRUG

Taken for 52 Weeks

Also known as: LNP023 and placebo

Iptacopan + placebo (part 2)

Iptacopan (part 1) DRUG

Taken for 52 Weeks

Also known as: LNP023

Iptacopan + standard of care (part 1)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (103)

AKDHC Medical Research ServicesLLC

Phoenix, Arizona, 85016, United States

WITHDRAWN

Kaiser Permanente Fontana

Fontana, California, 92335, United States

WITHDRAWN

Univ Calif Irvine

Irvine, California, 92697, United States

ACTIVE NOT RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Loma Linda University

San Bernardino, California, 92408, United States

ACTIVE NOT RECRUITING

Olive View UCLA Medical Center

Sylmar, California, 91342, United States

ACTIVE NOT RECRUITING

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Royal Research Corp

Hollywood, Florida, 33021, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Nephrology Associates Of Central FL

Orlando, Florida, 32806, United States

ACTIVE NOT RECRUITING

Florida Kidney Physicians

Riverview, Florida, 33578, United States

RECRUITING

Florida Kidney Physicians

Riverview, Florida, 33578, United States

RECRUITING

Nep Assoc of Northern Illinois

Hinsdale, Illinois, 60521, United States

ACTIVE NOT RECRUITING

Wichita Community Clcl Onco Program

Wichita, Kansas, 67214, United States

RECRUITING

Ochsner Health System

New Orleans, Louisiana, 70121, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

ACTIVE NOT RECRUITING

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

WITHDRAWN

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

ACTIVE NOT RECRUITING

Stony Brook Internists PC

East Setauket, New York, 11733, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

WITHDRAWN

Dallas Nephrology Associates

Dallas, Texas, 75204, United States

ACTIVE NOT RECRUITING

Prolato Clinical Research Center

Houston, Texas, 77054, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Novartis Investigative Site

Rosario, Santa Fe Province, 2000, Argentina

WITHDRAWN

Novartis Investigative Site

San Luis, 5700, Argentina

WITHDRAWN

Novartis Investigative Site

Santa Fe, S3000EPV, Argentina

ACTIVE NOT RECRUITING

Novartis Investigative Site

Salvador, Estado de Bahia, 40150 150, Brazil

ACTIVE NOT RECRUITING

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30150-221, Brazil

COMPLETED

Novartis Investigative Site

Juiz de Fora, Minas Gerais, 36010 570, Brazil

ACTIVE NOT RECRUITING

Novartis Investigative Site

Barretos, São Paulo, 14784 400, Brazil

ACTIVE NOT RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, 01308-050, Brazil

ACTIVE NOT RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, 04038-002, Brazil

ACTIVE NOT RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, 05403 000, Brazil

COMPLETED

Novartis Investigative Site

Salvador, 40323-010, Brazil

ACTIVE NOT RECRUITING

Novartis Investigative Site

Nanning, Guangxi, 530022, China

RECRUITING

Novartis Investigative Site

Wuhan, Hubei, 430022, China

RECRUITING

Novartis Investigative Site

Shenyang, Liaoning, 110004, China

RECRUITING

Novartis Investigative Site

Yinchuan, Ningxia, 750004, China

ACTIVE NOT RECRUITING

Novartis Investigative Site

Beijing, 100034, China

ACTIVE NOT RECRUITING

Novartis Investigative Site

Shenzhen, 518036, China

RECRUITING

Novartis Investigative Site

Barranquilla, Atlántico, 080020, Colombia

ACTIVE NOT RECRUITING

Novartis Investigative Site

Bogota, Cundinamarca, 111411, Colombia

ACTIVE NOT RECRUITING

Novartis Investigative Site

Bucaramanga, Santander Department, 680003, Colombia

ACTIVE NOT RECRUITING

Novartis Investigative Site

Montería, 230004, Colombia

ACTIVE NOT RECRUITING

Novartis Investigative Site

Marseille, 13005, France

COMPLETED

Novartis Investigative Site

Nantes, 44093, France

RECRUITING

Novartis Investigative Site

Paris, 75015, France

WITHDRAWN

Novartis Investigative Site

Strasbourg, 67091, France

WITHDRAWN

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

WITHDRAWN

Novartis Investigative Site

Ludwigshafen, Germany, 67063, Germany

WITHDRAWN

Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany

WITHDRAWN

Novartis Investigative Site

Braunschweig, Lower Saxony, 38126, Germany

RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 51109, Germany

RECRUITING

Novartis Investigative Site

Berlin, 13353, Germany

WITHDRAWN

Novartis Investigative Site

Mainz, 55131, Germany

RECRUITING

Novartis Investigative Site

Hong Kong, Hong Kong, 999077, Hong Kong

ACTIVE NOT RECRUITING

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

WITHDRAWN

Novartis Investigative Site

Budapest, H-1083, Hungary

WITHDRAWN

Novartis Investigative Site

Szeged, 6725, Hungary

WITHDRAWN

Novartis Investigative Site

Ahmedabad, Gujarat, 380015, India

WITHDRAWN

Novartis Investigative Site

Kozhikode, Kerala, 673008, India

RECRUITING

Novartis Investigative Site

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

RECRUITING

Novartis Investigative Site

Vellore, Tamil Nadu, 632 004, India

WITHDRAWN

Novartis Investigative Site

Hyderabad, Telangana, 500082, India

RECRUITING

Novartis Investigative Site

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

Novartis Investigative Site

Puducherry, 607402, India

WITHDRAWN

Novartis Investigative Site

Ashkelon, 7830604, Israel

WITHDRAWN

Novartis Investigative Site

Jerusalem, 9112001, Israel

WITHDRAWN

Novartis Investigative Site

Ramat Gan, 5265601, Israel

WITHDRAWN

Novartis Investigative Site

Kuantan, Pahang, 25100, Malaysia

RECRUITING

Novartis Investigative Site

Taiping, Perak, 34000, Malaysia

RECRUITING

Novartis Investigative Site

Selangor Darul Ehsan, 68100, Malaysia

RECRUITING

Novartis Investigative Site

Tampico, Tamaulipas, 89440, Mexico

ACTIVE NOT RECRUITING

Novartis Investigative Site

Mérida, Yucatán, 97070, Mexico

ACTIVE NOT RECRUITING

Novartis Investigative Site

Aguascalientes, 20230, Mexico

COMPLETED

Novartis Investigative Site

Veracruz, 91900, Mexico

ACTIVE NOT RECRUITING

Novartis Investigative Site

Makati City, National Capital Region, 1218, Philippines

RECRUITING

Novartis Investigative Site

Iloilo City, 5000, Philippines

WITHDRAWN

Novartis Investigative Site

Quezon, 1102, Philippines

RECRUITING

Novartis Investigative Site

Carnaxide, 2799-523, Portugal

ACTIVE NOT RECRUITING

Novartis Investigative Site

Coimbra, 3004-561, Portugal

ACTIVE NOT RECRUITING

Novartis Investigative Site

Lisbon, 1649-035, Portugal

ACTIVE NOT RECRUITING

Novartis Investigative Site

Porto, 4200 319, Portugal

WITHDRAWN

Novartis Investigative Site

Vila Nova de Gaia, 4434 502, Portugal

RECRUITING

FDI Clinical Research

San Juan, 00927, Puerto Rico

RECRUITING

Novartis Investigative Site

Singapore, Singapore, S308433, Singapore

RECRUITING

Novartis Investigative Site

Port de Sagunt, Valencia, 46520, Spain

WITHDRAWN

Novartis Investigative Site

Barcelona, 08036, Spain

ACTIVE NOT RECRUITING

Novartis Investigative Site

Ciudad Real, 13005, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28034, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28040, Spain

RECRUITING

Novartis Investigative Site

Seville, 41009, Spain

ACTIVE NOT RECRUITING

Novartis Investigative Site

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

ACTIVE NOT RECRUITING

Novartis Investigative Site

Istanbul, Fatih, 34093, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Novartis Investigative Site

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Novartis Investigative Site

Bursa, Nilufer, 16059, Turkey (Türkiye)

RECRUITING

Novartis Investigative Site

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Novartis Investigative Site

Mersin, Yenisehir, 33110, Turkey (Türkiye)

COMPLETED

Novartis Investigative Site

Cambridge, CB2 0QQ, United Kingdom

ACTIVE NOT RECRUITING

Novartis Investigative Site

Leicester, LE5 4PW, United Kingdom

WITHDRAWN

Related Publications (1)

• Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.

  PMID: 37528520 DERIVED

MeSH Terms

Conditions

Lupus Nephritis; Proteinuria; Lupus Erythematosus, Systemic

Interventions

iptacopan; Standard of Care

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 7, 2022
• Study Start: August 10, 2022
• Primary Completion: March 19, 2026
• Study Completion (Estimated): September 28, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); BR (8); HU (3); MY (3); ME (4); IL (3); CN (6); HK (1); PH (3); AR (3); ES (6); US (26); PT (5); DE (7); TU (6); IN (7); SG (1); CO (4); FR (4); GB (2)