Recruiting

Evaluation of Iptacopan (LNP023) with Standard-of-care for Active Lupus Nephritis Class III-IV

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the effectiveness of Iptacopan (LNP023) in combination with standard treatment for active Lupus Nephritis Class III-IV, by observing the proportion of patients achieving complete renal response at week 24, as measured by improved estimated glomerular filtration rate and reduced urine protein-to-creatinine ratio.

What is being tested

Iptacopan (part 1)

+ Iptacopan (part 2)

+ Placebo + standard of care

Drug
Who is being recruted

Urogenital Diseases+16

+ Autoimmune Diseases

+ Connective Tissue Diseases

From 18 to 100 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Study ContactNovartis PharmaceuticalsMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 10, 2022

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness, safety, and tolerability of a drug called iptacopan (LNP023) when used alongside standard treatment in patients with active Lupus Nephritis Class III-IV, +/- V. Lupus Nephritis is a kidney disease caused by systemic lupus erythematosus, an autoimmune disease. The study aims to find out if adding iptacopan to the usual treatment can improve outcomes for these patients, addressing a significant unmet need in managing this condition. In this study, participants are divided into groups and receive different combinations of treatments. Some groups receive iptacopan along with their standard treatment, while others receive only the standard treatment. The study's primary goal is to measure the proportion of patients achieving a 'Complete Renal Response' at week 24, in the absence of renal flares. A 'Complete Renal Response' is defined as having a specific estimated glomerular filtration rate (eGFR) and a 24-hour urine protein-to-creatinine ratio (UPCR) within certain values. These measurements help determine how well the kidneys are functioning.

Official TitleAn 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
NCT05268289
Principal SponsorNovartis Pharmaceuticals
Study ContactNovartis PharmaceuticalsMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesConnective Tissue DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisImmune System DiseasesKidney DiseasesLupus Erythematosus, SystemicLupus NephritisNephritisProteinuriaSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesSkin and Connective Tissue DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

3 inclusion criteria required to participate
Unequivocally positive ANA test result and/or a positive anti dsDNA at screening
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Iptacopan + standard of care

Group II

Active Comparator
Iptacopan + standard of care

Group III

Placebo
Placebo matching iptacopan standard of care

Group IV

Active Comparator
Placebo matching iptacopan + standard of care

Group 5

Active Comparator
Iptacopan + placebo standard of care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 103 locations

Recruiting

Ronald Reagan UCLA Medical Center

Los Angeles, United StatesOpen Ronald Reagan UCLA Medical Center in Google Maps
Recruiting

University of Colorado Denver

Aurora, United States
Recruiting

Royal Research Corp

Hollywood, United States
Recruiting

Mayo Clinic Jacksonville

Jacksonville, United States
Recruiting
103 Study Centers