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Phase 2RecruitingInterventionalNCT05268289

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

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

  • Lupus Nephritis
I want to take partRefer a patient7 sites in India (4 recruiting) · 103 worldwide

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
240
Started
10 August 2022
Main results
19 March 2026
Study ends (estimated)
28 September 2028
Allocation
Randomized
Design
Sequential
Purpose
Treatment
Masking
Quadruple (participant, care provider, investigator, outcomes assessor)
Sites
103 · 7 in India
First posted
7 March 2022
Registry updated
1 October 2026

Can you take part?

  • Ages 18 years to 100 years.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.

Age groups: adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Read the 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.

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

What participants receive

  • Active comparator

    Iptacopan + standard of care (part 1)

    Iptacopan + standard of care

    Drug: Iptacopan (part 1)

  • Placebo comparator

    Placebo matching iptacopan + standard of care (part 1)

    Placebo matching iptacopan standard of care

    Drug: Placebo + standard of care

  • Active comparator

    Iptacopan + standard of care (part 2)

    Iptacopan + standard of care

    Drug: Iptacopan (part 2)

  • Active comparator

    Iptacopan + placebo (part 2)

    Iptacopan + placebo standard of care

    Drug: Iptacopan + placebo

  • Active comparator

    Placebo matching iptacopan + standard of care (part 2)

    Placebo matching iptacopan + standard of care

    Drug: Placebo + standard of care

Interventions

  • Iptacopan (part 1)Drug

    Also known as LNP023

    Taken for 52 Weeks

  • Iptacopan (part 2)Drug

    Also known as LNP023

    Taken for 52 Weeks

  • Placebo + standard of careDrug

    Taken for 52 Weeks

  • Iptacopan + placeboDrug

    Also known as LNP023 and placebo

    Taken for 52 Weeks

What the study 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.

    Time frame: Baseline and week 24

Secondary outcomes

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

    Proportion of patients achieving complete renal response or partial renal response

    Time frame: Baseline, week 24, week 52

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

    Frequency of renal flares between weeks 24 and 52

    Time frame: Baseline, week 24 week 52

  3. Log-transformed ratio to baseline of 24h UPCR at 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)

    Time frame: Baseline week 24

  4. Change from baseline FACIT-Fatigue Score

    Measure fatigue in patients

    Time frame: Weeks 24 and 52

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

    Measure disease activity in SLE

    Time frame: Weeks 24 and 52

  6. Change from baseline in BILAG-2004 score at weeks 24 and 52

    Measure disease activity

    Time frame: Weeks 24 and 52

  7. Time-to-Complete Renal Response (CRR) based on first morning void(FMV) urine samples

    Measurement of time to complete renal response based on urine samples

    Time frame: Week 24 and Week 52

Who is running it

Lead sponsor
Novartis Pharmaceuticals
Sponsor type
Industry
Responsible party
The sponsor
Organisation
Novartis
Data monitoring committee
Yes
US FDA-regulated drug
Yes
US FDA-regulated device
No
Sponsor's study ID
CLNP023K12201
Other IDs
2021-002046-33

  • Novartis Pharmaceuticals

    Study director

    Novartis Pharmaceuticals

Study sites(103)

  • Novartis Investigative Site

    Kozhikode, Kerala, India

    Recruiting

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, India

    Recruiting

  • Novartis Investigative Site

    Hyderabad, Telangana, India

    Recruiting

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, India

    Recruiting

  • Novartis Investigative Site

    Ahmedabad, Gujarat, India

    Withdrawn

  • Novartis Investigative Site

    Vellore, Tamil Nadu, India

    Withdrawn

  • Novartis Investigative Site

    Puducherry, India

    Withdrawn

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, United States

    Recruiting

  • University of Colorado Denver

    Aurora, Colorado, United States

    Recruiting

  • Royal Research Corp

    Hollywood, Florida, United States

    Recruiting

  • Florida Kidney Physicians

    Riverview, Florida, United States

    Recruiting

  • Florida Kidney Physicians

    Riverview, Florida, United States

    Recruiting

  • Wichita Community Clcl Onco Program

    Wichita, Kansas, United States

    Recruiting

  • Ochsner Health System

    New Orleans, Louisiana, United States

    Recruiting

  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts, United States

    Recruiting

  • Stony Brook Internists PC

    East Setauket, New York, United States

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, United States

    Recruiting

  • Temple University

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Prolato Clinical Research Center

    Houston, Texas, United States

    Recruiting

  • Novartis Investigative Site

    Wuhan, Hubei, China

    Recruiting

  • Novartis Investigative Site

    Shenyang, Liaoning, China

    Recruiting

  • Novartis Investigative Site

    Shenzhen, China

    Recruiting

  • Novartis Investigative Site

    Nantes, France

    Recruiting

  • Novartis Investigative Site

    Braunschweig, Lower Saxony, Germany

    Recruiting

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, Germany

    Recruiting

  • Novartis Investigative Site

    Mainz, Germany

    Recruiting

  • Novartis Investigative Site

    Budapest, Hungary

    Recruiting

  • Novartis Investigative Site

    Kuantan, Pahang, Malaysia

    Recruiting

  • Novartis Investigative Site

    Taiping, Perak, Malaysia

    Recruiting

  • Novartis Investigative Site

    Selangor Darul Ehsan, Malaysia

    Recruiting

  • Novartis Investigative Site

    Makati City, National Capital Region, Philippines

    Recruiting

  • Novartis Investigative Site

    Quezon, Philippines

    Recruiting

  • Novartis Investigative Site

    Vila Nova de Gaia, Portugal

    Recruiting

  • FDI Clinical Research

    San Juan, Puerto Rico

    Recruiting

  • Novartis Investigative Site

    Singapore, Singapore, Singapore

    Recruiting

  • Novartis Investigative Site

    Ciudad Real, Spain

    Recruiting

  • Novartis Investigative Site

    Madrid, Spain

    Recruiting

  • Novartis Investigative Site

    Madrid, Spain

    Recruiting

  • Novartis Investigative Site

    Bursa, Nilufer, Turkey (Türkiye)

    Recruiting

  • AKDHC Medical Research ServicesLLC

    Phoenix, Arizona, United States

    Withdrawn

Showing 40 of 103 sites, filter to narrow it down. 36 of 103 on this study are recruiting right now, and 7 are in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

  • 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
Participant data shared
Yes

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

Source: ClinicalTrials.gov record NCT05268289, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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