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LNP023 for Membranous Nephropathy

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 15, day 29, day 57, day 85, day 113, day 141, day 169, day 266 and day 378
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, LNP023, against an existing one, rituximab, in patients with a kidney disease called membranous nephropathy who are at high risk of worsening. LNP023 targets immune system proteins, and rituximab reduces certain immune cells. Rituximab has been used for many years to treat idiopathic membranous nephropathy, showing effectiveness in inducing remission with fewer side effects compared to traditional immunosuppressive therapies.

Eligible Conditions
  • Membranous Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 15, day 29, day 57, day 85, day 113, day 141, day 169, day 266 and day 378
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 15, day 29, day 57, day 85, day 113, day 141, day 169, day 266 and day 378 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection)
Secondary study objectives
Change From Baseline in (eGFR) Estimated Glomerular Filtration Rate Over Time
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb)
Change From Baseline in Plasma Levels of sC5b-9
+7 more

Side effects data

From 2023 Phase 3 trial • 97 Patients • NCT04558918
20%
COVID-19
17%
Breakthrough haemolysis
9%
Pyrexia
9%
Nasopharyngitis
9%
Sinusitis
9%
Upper respiratory tract infection
9%
Blood lactate dehydrogenase increased
6%
Diarrhoea
6%
Back pain
3%
Sepsis
3%
Extravascular haemolysis
3%
Jaundice
3%
Arthritis bacterial
3%
Intervertebral discitis
3%
Pseudomonal sepsis
3%
Influenza A virus test positive
3%
Acute kidney injury
3%
Bilirubinuria
3%
Abdominal pain
3%
Nausea
3%
Vomiting
3%
Urinary tract infection
3%
Arthralgia
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anti-C5 Antibody (Randomized Treatment Period)
Any LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LNP023Experimental Treatment1 Intervention
As per protocol V00, participants took LNP023 10 mg orally b.i.d. for 4 weeks followed by LNP023 50 mg orally b.i.d. for 20 weeks. As per protocol amendment V01, participants took LNP023 50mg orally b.i.d. for 4 weeks followed by LNP023 200mg for 20 weeks.
Group II: RituximabActive Control1 Intervention
Rituximab 1 g i.v. at Day 1 and Day 15
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LNP023
2019
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,640 Total Patients Enrolled
~6 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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