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LNP023 for Membranous Glomerulonephritis

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 day 29 and day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose)
Awards & highlights

Study Summary

This trial will compare LNP023 to rituximab to see if LNP023 is more effective and safe in treating MN.

Eligible Conditions
  • Membranous Glomerulonephritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29 and day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 and day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ratio between baseline Urine Protein Creatinine Ratio and Urine Protein Creatinine Ratio at 24 weeks of treatment (from 24h urine collection)
Secondary outcome measures
Change in (eGFR) estimated Glomerular Filtration Rate from baseline to 24 weeks of treatment
Meausrement of Plasma levels of Bb and sC5b-9
Pharmacokinetic parameter AUClast in plasma
+7 more

Side effects data

From 2023 Phase 3 trial • 97 Patients • NCT04558918
20%
COVID-19
17%
Breakthrough haemolysis
9%
Blood lactate dehydrogenase increased
9%
Pyrexia
9%
Sinusitis
9%
Nasopharyngitis
9%
Upper respiratory tract infection
6%
Diarrhoea
6%
Back pain
3%
Vomiting
3%
Headache
3%
Pseudomonal sepsis
3%
Abdominal pain
3%
Nausea
3%
Extravascular haemolysis
3%
Bilirubinuria
3%
Arthralgia
3%
Jaundice
3%
Sepsis
3%
Intervertebral discitis
3%
Influenza A virus test positive
3%
Arthritis bacterial
3%
Acute kidney injury
3%
Urinary tract infection
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)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LNP023Experimental Treatment1 Intervention
LNP023
Group II: RituximabActive Control1 Intervention
Rituximab
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
2,866 Previous Clinical Trials
4,199,289 Total Patients Enrolled
~7 spots leftby May 2025