Recruiting
Phase 2

LNP023

Sponsor:

Novartis Pharmaceuticals

Code:

NCT05268289

Conditions

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Iptacopan (part 1)

Iptacopan (part 2)

Placebo + standard of care

Iptacopan + placebo

Study Details

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

Study ID

NCT05268289

Start date

Aug 10, 2022

Status verified date

Jul, 2026

Completion date

Sep 28, 2028

Anticipated

Primary completion date

Mar 19, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Iptacopan + standard of care (part 1)

Iptacopan + standard of care

placebo comparator: Placebo matching iptacopan + standard of care (part 1)

Placebo matching iptacopan standard of care

active comparator: Iptacopan + standard of care (part 2)

Iptacopan + standard of care

active comparator: Iptacopan + placebo (part 2)

Iptacopan + placebo standard of care

active comparator: Placebo matching iptacopan + standard of care (part 2)

Placebo matching iptacopan + standard of care

Interventions

Iptacopan (part 1)

Taken for 52 Weeks

Iptacopan (part 2)

Taken for 52 Weeks

Placebo + standard of care

Taken for 52 Weeks

Iptacopan + placebo

Taken for 52 Weeks

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111

Locations

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Rana Nikbakht Malvajerdi

RNikbakht@mednet.ucla.edu

Principal Investigator:

Lama Abdelnour

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Amber Podoll

Royal Research Corp

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Principal Investigator:

Elio Torres

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Principal Investigator:

Nabeel Aslam

Florida Kidney Physicians

Recruiting

Riverview, Florida, United States, 33578

Contacts

Principal Investigator:

Amit Johnsingh

Florida Kidney Physicians

Recruiting

Riverview, Florida, United States, 33578

Contacts

Principal Investigator:

Marc Richards

Wichita Community Clcl Onco Program

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Principal Investigator:

Wissam Saliba

Ochsner Health System

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Principal Investigator:

Ivo Lukitsch

Brigham and Womens Hosp Harvard Med School

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Valentina Castro

vcastro3@bwh.harvard.edu

Principal Investigator:

Finnian McCausland

Stony Brook Internists PC

Recruiting

East Setauket, New York, United States, 11733

Contacts

Principal Investigator:

Sobia Khan

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Sarah Cleveland

clevels@ccf.org

Principal Investigator:

Laura Ferreira-Provenzano

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Principal Investigator:

Iris Lee

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Principal Investigator:

Biruh Workeneh

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Jason Kidd

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-30.