Last Update: Dec 22, 2025
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLNP023K12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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. 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.

Lupus Nephritis
Phase2
Recruiting
240
Aug 10, 2022
Sep 28, 2028
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

Iptacopan (part 1)

Taken for 52 Weeks
Drug

Iptacopan (part 2)

Taken for 52 Weeks
Drug

Iptacopan + placebo

Taken for 52 Weeks
Drug

Placebo + standard of care

Taken for 52 Weeks

Eligibility Criteria

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

Novartis Investigative Site

Recruiting

Shenyang,Liaoning,110004,China

Novartis Investigative Site

Recruiting

Wuhan,Hubei,430022,China

Novartis Investigative Site

Recruiting

Nanning,Guangxi,530022,China

Novartis Investigative Site

Recruiting

Shenzhen,518036,China

Novartis Investigative Site

Recruiting

Cologne,North Rhine-Westphalia,51109,Germany

Novartis Investigative Site

Recruiting

Mainz,55131,Germany

Novartis Investigative Site

Recruiting

Vila Nova de Gaia,4434 502,Portugal

FDI Clinical Research

Recruiting

San Juan,00927,Puerto Rico

Jose Cangiano
Digmarie Rivera Franceschini

Novartis Investigative Site

Recruiting

Madrid,28040,Spain

Novartis Investigative Site

Recruiting

Ciudad Real,13005,Spain

Novartis Investigative Site

Recruiting

Madrid,28034,Spain

Novartis Investigative Site

Recruiting

Bursa,Nilufer,16059,Turkey (Türkiye)

Virginia Commonwealth University

Recruiting

Richmond,Virginia,23298,United States

Keila Najera
Jason Kidd

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles,California,90095,United States

Lama Abdelnour
Rana Nikbakht Malvajerdi

Loma Linda University

Recruiting

San Bernardino,California,92408,United States

Sayna Norouzi
Gema Castaneda Duenas

University of Colorado Denver

Recruiting

Aurora,Colorado,80045,United States

Amber Podoll
Elizabeth Wagner

Cleveland Clinic Foundation

Recruiting

Cleveland,Ohio,44195,United States

Sarah Cleveland
Laura Ferreira-Provenzano

Royal Research Corp

Recruiting

Hollywood,Florida,33021,United States

Elio Torres
Yalily Perez

Mayo Clinic Jacksonville

Recruiting

Jacksonville,Florida,32224,United States

Cameron King
Nabeel Aslam

Florida Kidney Physicians

Recruiting

Riverview,Florida,33578,United States

Amit Johnsingh
Jamie Coney
Yvette Martinez
Marc Richards

Prolato Clinical Research Center

Recruiting

Houston,Texas,77054,United States

Dilshad Begum
Biruh Workeneh

Temple University

Recruiting

Philadelphia,Pennsylvania,19140,United States

Julia Aruta
Iris Lee

Stony Brook Internists PC

Recruiting

East Setauket,New York,11733,United States

Sobia Khan
Melissa Espinoza

Brigham and Womens Hosp Harvard Med School

Recruiting

Boston,Massachusetts,02115,United States

Valentina Castro
Finnian McCausland

Ochsner Health System

Recruiting

New Orleans,Louisiana,70121,United States

Ivo Lukitsch
Gavin Skipper

Wichita Community Clcl Onco Program

Recruiting

Wichita,Kansas,67214,United States

Wissam Saliba
Barb Johnson

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals